Manufacturing Associate Resume Samples

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S Prosacco

Saige

Prosacco

639 Marlee Park

Houston

+1 (555) 897 5476

639 Marlee Park

Houston

Phone

p +1 (555) 897 5476

Experience Experience

San Francisco, CA

Manufacturing Associate

San Francisco, CA

Cole Inc

San Francisco, CA

Manufacturing Associate

6) Participate on Continuous Improvement teams and implement continuous improvement tools in the area, such as 6S visual management and standard work
Satisfaction in working at the cutting edge of biotech, and seeing your work make a difference in the world
Perform all tooling or carbide changes, and troubleshoot and make necessary adjustments to equipment
Performs rework per rework instructions
Provide guidance and expert advice to management or other groups on recruiting, selection and retention. Lead job modeling sessions for hiring managers
Perform 5S in the workstation
Provide other assistance as assigned by the Production Lead

Detroit, MI

Lead Manufacturing Associate

Detroit, MI

Hoppe-Hills

Detroit, MI

Lead Manufacturing Associate

Identify, develop and implement process improvements, equipment improvements/upgrades
Assist in daily analysis of scrap to identify training/improvement opportunities in manufacturing processes
Perform set-up and change-over on equipment
Provides training and operational guidance to junior staff and also serves to mentor junior staff in manufacturing techniques
Understand all work requests, personnel support for these requests and effectively communicate schedules to Supervisor
Perform several basic Manufacturing operations or some complex manufacturing operations proficiently
Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions

present

Chicago, IL

Senior Manufacturing Associate

Chicago, IL

Pouros, Herman and Doyle

present

Chicago, IL

Senior Manufacturing Associate

present

May provide feedback to area management on junior staff performance
Performs batch record review, procedure revisions, and work order generation
Mentor new recruits and assist in staff development and training
Performs the manufacturing process for the production of Cell & Gene Therapy products, Master and Working Cell Banks, and final product fills
Performs batch record review, procedure revisions and work order generation
Works with senior manufacturing personnel to improve and optimize manufacturing methods
Implement continuous improvements in ABC Production, using CI methodologies such as Lean

Education Education

Bachelor’s Degree in Life Sciences

Ashford University

Bachelor’s Degree in Life Sciences

Skills Skills

Have good understanding and be knowledgeable on Good Manufacturing Practice (GMP) and filling Device History Record (DHR)
Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area
Proficient and knowledgeable in the operation and basic to moderate troubleshooting of at least two manufacturing area
Theoretical Knowledge - Basic knowledge of chemicals and laboratory equipment
Proficient and knowledgeable in the operation and moderate to complex troubleshooting of two or more manufacturing area’s
Able to read and follow detailed English written instructions and have good verbal/written communication skills
Strong organizational skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential
Ability to interface with Quality Control, Quality Assurance, Materials Management
Demonstrated ability to perform basic mathematical calculations and be able to measure to a 1/4 inch reliably and consistently
Ability to assist in writing master batch records and complete Batch Production Records under Good Manufacturing Practices

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Manufacturing Associate Resume Examples & Samples

Visually insure component location and orientation is correctly installed
Operate machinery and test equipment used in the manufacture of circuit boards
Visually inspect small components for damage and ensure the correct part is being installed
Follow written instructions and established procedures. Follow company, plant, and departmental rules and regulations
Uses a variety of hand tools to complete tasks
Prepare finished products for packing and shipping containers
Prepare and maintain reports and records as needed
Perform 5S in the workstation

Manufacturing Associate Resume Examples & Samples

Machining to conduct alterations and necessary repairs on tools, gages and fixtures
Perform machine tool set-ups with proficiency and in a safe manner
Assure all fixtures and gages (simple and complex) are calibrated and/or fabricated to specifications with minimal assistance
Typical tasks include, but are not limited to the following
Understand and work to the P&W tool related procedures
Fabricate and Calibrate ID/OD gages for inspection of diameters, compute compound angles accurately and with proficiency
Accept responsibility for fixturing and gaging to be within specification, assure tools are properly identified with all information including tool number, weight and change letter
Accurately and thoroughly execute related SAP transactions
Complete all required activity related to machine sign-in procedures, clean-up and maintenance of equipment, clocking procedures, tooling sign-out for inventory management
Follow EHS guidelines and procedures such as use of proper P.P.E., following Job Safety Analysis work sheets and watching for the safety of co-workers
Work to ACE initiatives following guidelines; contribute to continuous improvement of all work-related functions

Vandalia Manufacturing Associate Resume Examples & Samples

1 year of experience in electronic assembly
1 year of manufacturing or mechanical work experience
1 year of prior assembly experience

Vandalia Manufacturing Associate Resume Examples & Samples

Perform electrical connections for electrical, electro/mechanical, and electronic assemblies
Insert, wind, and connect all coils, transformers, armatures, exciters, inductance coils, rotors, and stators as necessary
Complete assemblies using nuts, bolts, and screws
Perform mechanical measurements using scales, calipers, and gages
Solder and braze assemblies, sub-assemblies, and components as necessary
Perform potting, coating, and cleaning of all components
Review, understand, and follow routers, procedures, specification, and other instructions for completeness to perform operation
Build up electrical harness assemblies and other types of controllers
Assemble and disassemble electrical components
Coat assemblies with various solutions per specifications
Use pneumatic and hand tools to perform assembly tasks
Keep all machinery, tools, and work areas clean
Apply basic math calculations (addition, subtraction, multiplication and division of fractions, decimals, and whole numbers)
Maintain strong attention to detail and knowledge of production processes
Demonstrate manual dexterity to perform assembly tasks in a safe and efficient manner
Maintain an excellent record of attendance and punctuality
Work in a team-based environment
Make decisions based on experience and available data
Accept and give constructive criticism
Maintain a positive attitude
Demonstrate an ambition to excel and advance in skills and knowledge
Conform to all EHS guidelines including, but not limited to, wearing proper PPE
Work in an area where there may be moderate noise intensity (85 to 89.9 dBa) and areas where hearing protection is required
Work in an area where, due to normal machining operations, there may be dust, fumes, or smoke (not over OSHA Permissible Exposure Levels)
Lift up to 25 pounds repetitively, occasionally lift up to 35 pounds non-repetitively, and sometimes lift over 35 pounds with assistance
Successful candidate may be required to take classes in team building, environmental health and safety, and/or other on-the-job training to learn specific assignments
Comply with and support all GE policies and the “Integrity: The Spirit and The Letter of Our Commitment” guide
Able and willing to read and understand applicable information such as written instructions, procedures and specifications that apply to daily work operations
Able and willing to use hand tools (pliers, wrenches, hammers, etc.)
Able and willing to enter a randomized drug & alcohol testing program
Able and willing to solder and braze
Able and willing to perform light machining including but not limited to drill press, flush and back flush, lead cutting, stripping and forming
Able and willing to perform mechanical measurements using scales, calipers, and gauges
Able and willing to use pneumatic tools

Vandalia Manufacturing Associate Resume Examples & Samples

Build and assemble rotors, stators, and generators
Vacuum impregnate wound components
Perform light machining as necessary
Able and willing to read and understand applicable information such as prints, written instructions, procedures and specifications that apply to daily work operations

Manufacturing Associate Resume Examples & Samples

Follow standard operating procedures to assemble, test and package products
Follow all job safety recommendations
Enter data into ERP systems
Experienced in the use of hand tools, powered tools including routers, sanders, dremmel tools and measuring devices
Must be able to work with minimal supervision but also to take direction from team members in a small but highly motivated manufacturing team
Must have excellent housekeeping skills and be able to work with a very sticky Epoxy adhesive and 2-propanl without causing contamination of product, tools and equipment
This is in Liqi-Cels most physically demanding production area. Some of the jobs the applicant will be required to do
Hold one end of a 10” diameter stainless steel pipe while using a custom tool to manually push a very tight o-ring into place with the other hand
Lift a 40” long pipe over the potting bundles
Maneuver drum dollies containing 55 gallons of Epoxy
Manually break loose large 1” nuts from epoxy potting molds
Manually break loose large epoxy cartridges from the potting molds
Maneuver 3” water lines into place during testing
Manually slide tight plastic sleeve over large bundle diameters
Maneuver a production cart containing 300 lbs. of product down the hallway to the other production area 150 yards away
Work in a wet testing environment--will be required to wear water proof safety shoes
Minimum one (1) year of manufacturing and/or mechanical assembly experience
Minimum three (3) years of manufacturing experience
Minimum three (3) years of mechanical assembly experience
Previous experience using hand and/or power tools

Manufacturing Associate Resume Examples & Samples

Under moderate supervision, perform all responsibilities necessary to operate, troubleshoot, set up, adjust, repair and maintain equipment and execute the manufacturing processes
Perform a variety of tasks including but not limited to process execution and monitoring to assure product quality and manufacturing throughput
Perform routine cleaning, housekeeping and non-routine maintenance
Adhering to strict compliance with procedures according to the roles and responsibilities
Move material and product to and from work centers within the manufacturing site
Accurately complete paperwork and electronic transactions for all documentation requirements including but not limited to computer transactions, batch record steps and paper and electronic logbooks
Drive continuous improvement including the identification of opportunities to improve production and efficiency in a compliant safe manner
This position requires a High school diploma or its equivalent. An Associate’s degree or Bachelor's degree is preferred
A minimum of 2 years of experience working in a manufacturing environment is required
Pharmaceutical/GMP experience is preferred
Candidates must be able to meet the physical demand of that this position requires: continuous lifting and/or moving from 5 to 25lbs. weight material, and frequent lifting or moving average (25-50 lbs) weight material
Candidates must successfully pass 5 written skills tests to be considered for hire
A basic working knowledge of Microsoft Word and Excel is required.Production

Manufacturing Associate Resume Examples & Samples

Log-on to the computer and scan work order
Read process sheet and blueprint for the work order
Set-up the seal machines in the cell, by adding tooling to the machines
Process parts through machining
Measure seals using tools such as micrometers, pi tape, gauge, venires, etc. by checking dimensions as indicated on the blueprints
Place completed seals on the rack and take finished product to designated area
Document and control dimension using the SPC (statistically process control)
Participate in lean and 5S+ activities, as required
Complete and maintain production line logs

Manufacturing Associate Resume Examples & Samples

High School Diploma or GED Required
At least 18 years of Age
Basic Computer Literacy
Basic Reading and Writing

Manufacturing Associate D-material Handling Resume Examples & Samples

US Work Authorization
90 days minimum Rockwell service
Previous material handling & fork-truck experience preferred

Manufacturing Associate D Resume Examples & Samples

HS Diploma
US work authorization
Minimum of 90 days of Rockwell service
Previous material handling experience

Manufacturing Associate Resume Examples & Samples

Demonstrated ability to follow written or verbal directions
Demonstrated ability to perform basic mathematical calculations and be able to measure to a 1/4 inch reliably and consistently
Must be able to lift up to 50 pounds for an 8 hour shift
Must be able to work up to 50 hours a week (mandatory Overtime until the second shift is staffed)
2ND SHIFT POSITION 2-10:30PM

Manufacturing Associate Resume Examples & Samples

Assemble RTD sensors, thermocouples, thermistors and speed sensors
Participate in all required training
Understand and support Trade Compliance policies
Provide other assistance as assigned by the Production Lead
Must be able to read and write and possess basic mathematical skills
Must be comfortable working independently or as a member of a team
Good hand/eye coordination, dexterity and attention to detail required
High school diploma or GED at a minimum
Formal training in welding processes through trade school, technical college or prior OJT. (certification a plus)
Tig Welding experience a plus – minimum of 5 years proven experience preferred
Experience with both ferrous and non-ferrous metals, with strong background with 300 series stainless steels
Brazing experience is a plus
Soldering experience a plus
Promote teamwork and cooperative effort
Help train and give guidance to employees
Provide customers with the highest quality of products and services
Report to work as scheduled

Manufacturing Associate Resume Examples & Samples

Mounts assembled components, such as transformers, resistors, transistors, capacitors, integrated circuits, and sockets, on circuit cards and chassis assemblies
Connects component lead wires to printed circuit or routes and connects wires between individual component leads and other components, connectors, terminals, and contact points
Connects wires to wire-wrap panels according to wire lists
Assembles and attaches hardware, such as caps, clamps, knobs, and switches, to assemblies
Performs intermediate assembly tasks, such as potting, encapsulating, sanding, cleaning, epoxy bonding, curing, stamping, etching, impregnating, and color-coding parts and assemblies
Performs rework per rework instructions
Works to engineering drawing, sketches and verbal direction, works on major complex assemblies with little or no manufacturing assistances, can offer up manufacturing suggestions to improve process flow
High School Diploma and five years or more of related experience
Soldering, wire-wrapping

Manufacturing Associate Resume Examples & Samples

Possession of a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in life sciences or a related field, or four (4) years of equivalent experience in lieu of degree
Foreign degrees must be evaluated for U.S. equivalency
A minimum of two (2) years of progressively responsible experience in GMP biotech or cell culture/fermentation
Knowledge of the regulatory issues associated with cGMP manufacturing of biopharmaceutical products
Knowledge of cGMP’s as they relate to manufacturing operations
Ability to write and follow standard operating procedures
Ability to assist in writing master batch records and complete Batch Production Records under Good Manufacturing Practices
Working knowledge of computer assisted manufacturing/production equipment
Ability to work in a BL2 environment
Ability to be gowning certified
Possession of one or more skills in the following areas
Cell culture
Fermentation
Ability to interface with Quality Control, Quality Assurance, Materials Management

Manufacturing Associate Resume Examples & Samples

Possession of a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in life sciences or a related field, or four (4) years equivalent experience in lieu of degree
No experience is required with a Bachelor’s degree
Four years of job related experience in a pharmaceutical cGMP environment may be substituted for the degree
Cleanroom and BL2 experience
This position may require work on 2nd or 3rd shift and weekends as needed
Knowledge of at least one of the following

Manufacturing Associate Resume Examples & Samples

Possession of a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in life sciences or a related field, or four years’ equivalent experience in lieu of degree
Foreign degrees must be evaluated for U.S. Equivalency
A minimum of two (2) years progressively responsible experience in GMP biotech or cell culture/fermentation

Manufacturing Associate Resume Examples & Samples

Performs the manufacturing process for the production of clinical and commercial Cell & Gene Therapy products, Master and Working Cell Banks, and final product fills
Demonstrates technical knowledge and contributes to the overall operations
Contributes to the achievement of departmental goals and objectives
Understands the importance of the regulatory compliance requirements for the production of biologics
Participates in manufacturing operations in assigned area per cGMPs
Authors Batch Production Records, Standard Operating Procedures (SOP’s) and Solution Preparation Records as needed to accurately reflect manufacturing processes
Completes production records and maintains clean room environment to comply with regulatory requirements
Assists in the startup and validation efforts for the Manufacturing Facility and may represent Manufacturing during Factory Acceptance Testing of new equipment
Ensures junior manufacturing personnel comply with standard operating procedures and master production records
Works on routine manufacturing assignments as well as other assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations
Normally receives no instructions on routine work and general instructions on new assignments
Works under minimal supervision from the area supervisor or area leader
High School diploma and at least 2 year experience or Bachelor’s degree
Meets physical requirements of the job, as follows: must have the ability to lift a minimum of 50 pounds, stand for long periods, bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks
Experience in aseptic processing techniques a plus
Clarity of vision at near and mid-ranges (less than 20 feet), depth perception and ability to identify and distinguish colors
Holiday and shift work often required based on manufacturing schedule as determined by Management

Senior Manufacturing Associate Resume Examples & Samples

Performs the manufacturing process for the production of Cell & Gene Therapy products, Master and Working Cell Banks, and final product fills
Contributes to the achievement of company and departmental goals and objectives
Has a working knowledge of the regulatory compliance requirements for the production of commercially manufactured biologics
Often functions as the lead operator in manufacturing operations in assigned area per cGMPs
Ensures junior manufacturing personnel comply with Standard Operating Procedures (SOP’s) and Batch Records and that training records for junior staff are accurate and current
In conjunction with management personnel, participates in the technical transfer, planning, implementation, and maintenance of manufacturing processes and procedures
Authors Adverse Events and Reviews Validation reports and Master Production Records to ensure documents are accurate and complete
Evaluates operating procedures for accuracy and efficient operation and makes corrections as necessary
Expert on all aspects of assigned processes
Provides training and operational guidance to junior staff and also serves to mentor junior staff in manufacturing techniques
Provides technical expertise to area associates and supervision during process and equipment troubleshooting exercises
Bachelor’s degree with major in Biology, Chemistry or related Science major and 4 years of experience in cell production/biologics facility or equivalent
Must have Commercial Biologics Manufacturing Experience
Ability to work under limited supervision and to handle problems of a more difficult nature
Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations
Must be able to wear appropriate clean room attire (i.e. surgical masks) and all Personal Protective Equipment (PPE)

Manufacturing Associate Resume Examples & Samples

Applies Job skills, GMP's and Solta's company polices and work instructions to perform routine work related to the production of complements. Sub-assemblies and final assemblies
Able to perform and verify line clearance in each work station as required, verification of the accuracy and completeness of the job/label print traveler
Work as part of the Manufacturing team to meet Production goals
Fast paced, repetitive wiring and electrical component assembly tasks of precision assemblies. Repetitive and electro-mechanical assembly of precision components and assemblies. Assembly tasks may entail the use of a variety of adhesives. Tasks may require use of Electrostatic Dissipation devices (straps). Tasks require careful handling techniques to prevent damage to product. Some of these tasks require the use a microscope
Component inspection per Solta's specifications
Component cleaning and packaging. Some cleaning and packaging operations may be performed according to proper procedures. (Restrictive clothing and hygiene requirements apply)
Operation of a variety of mechanical and electro-mechanical assembly, curing fixtures and equipment
Electrical programming and testing operations utilizing various test fixtures and results, yield information and other data as required onto Solta traveler documents of other data collection devices
Recording of lot control, inspection results, test results, yield information and other data as required onto Solta traveler documents of other data collection devices

Manufacturing Associate Resume Examples & Samples

A High School diploma or equivalent combined with 5-8 years of experience, or a Biotechnology Certificate or Associate’s Degree in science related field combined with 3-5 years of experience is required
A Bachelor’s Degree in Physical or Chemical Sciences (life sciences) or related Engineering field, and a minimum of 1-3 years of experience is preferred
Experience with operating automated manufacturing control systems is preferred
Experience utilizing parts washers and autoclaves for the preparation of manufacturing and/or laboratory equipment
Critical understanding of the importance of documentation and data traceability
Extensive familiarity with executing Standard Operating Procedures in a manufacturing or assembling environment, preferably in the pharmaceutical industry
Strong working knowledge of Good Documentation and current Good Manufacturing Practices
Demonstrated ability to perform product and/or process investigations preferred
Experience operating automated manufacturing control systems is preferred
Ability to multi-task and adjust priorities as necessary
Ability to manage both day-to-day operations as well as project work in a fast paced environment
This position requires minimum travel. Average travel for this position is less than 5% with some variation based upon the demands of business imperatives

Senior Manufacturing Associate Resume Examples & Samples

High school diploma with a minimum of 8 years relevant bio-manufacturing experience required
Biotechnology Certificate from an accredited institution and/or an Associate’s degree in a science related or engineering field, with a minimum of 5-8 years of related experience preferred
Bachelor’s degree in a science related or engineering field, and a minimum 3-5 years of related experience preferred
Extensive experience with operating automated manufacturing control systems, utilizing parts washers and autoclaves for the preparation of manufacturing and/or laboratory equipment
Strong working knowledge of Good Documentation and current Good Manufacturing Practices required
Experience with the revision and review of Standard Operating Procedures and Batch/Production Records in a manufacturing, preferably in the pharmaceutical industry
Demonstrated experience to perform product and/or process investigations
Demonstrated experience to train and develop employees in a manufacturing environment
Experience with automated manufacturing control systems required
Ability to manage multiple priorities at one time and adjust priorities as necessary
Must be able to work well independently and in a team environment
Must have the ability to lift up to 50 pounds
Requires physical activity such as standing for long periods of time, walking, and working with hands
Must be able to work in a controlled or clean room environment requiring special gowning
Some weekends or holidays may be required

Manufacturing Associate, Fermentation Resume Examples & Samples

Prepares components, media and solutions as needed
Trains others on execution of manufacturing processes and utilization of equipment
May lead project planning, execution & wrap up
May function as subject matter expert with clients for manufacturing programs

Senior Manufacturing Associate, Fill Finish Resume Examples & Samples

Performs various semi-routine manufacturing tasks under the guidelines of established SOP’s and cGMP regulations
Writes deviations, OOS and any other investigations pertaining to the group
Works with Management to implement process improvements, trainings, new projects and facility repairs
Interacts with other Manufacturing associates helping to streamline processes and ensure oversight throughout operations
Responsible for communicating issues or deviations in a timely manner to the client
May troubleshoot manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of manufacturing supervisor
Develops expertise in specific areas of manufacturing which add value to the company
Assists in the research and implementation of new methods and technologies to enhance operations. Routinely implements production and manufacturing procedures
Assists in the development of scalable processes with improved product yield and reduced costs for manufacturing systems
Responsible for routine maintenance of production equipment and production suites. May research and procure equipment for multiple manufacturing processes
Initiates and writes revisions to current GMP/SOP guidelines. Reliably executes and writes well defined SOP’s and manufacturing batch records

Manufacturing Associate Resume Examples & Samples

Production, filling and inspection of pharmaceutical formulations
Assist with facility cleaning and operational maintenance
Assist with facility and process validations as required
Perform aseptic production operations and validations
Assist with environmental monitoring as required
Assist with clean room sanitization as required
Assist with RCRA and safety inspections as required
Document all work as required by CGMPs on a timely basis
Read and follow all Company SOPs and guidelines
Abide by all safety requirements as defined by the company
Basic knowledge of the Scientific Method including chemistry and biology, along with math skills, including simple algebra
Ability to read, understand and accurately follow company SOPs and guidelines
Basic knowledge of steam/dry heat sterilization theories
Basic knowledge of HAZCOM, RCRA and other Safety requirements
Basic level of mechanical/technical aptitude
Good documentation skills and attention to detail
Ability to lift / move 40 lbs. overhead
Ability to learn how to operate all types of production equipment (I.e. Autoclave, Dry Heat Oven, etc.)
Good collaborative/team skills; works well in small team environment
Readily adapts to changing job duties and ability to work under pressure
Motivated, disciplined, flexible

Manufacturing Associate Resume Examples & Samples

Organization and interpersonal Skills (Oral, Written, etc.)
Good Computer and Database Skills
Comprehensive training focused on current Good Manufacturing Practices (cGMP) in the pharmaceutical industry
Experience in GMP manufacturing facility desirable
Vial or general inspection experience desirable

Manufacturing Associate Resume Examples & Samples

Operate manufacturing equipment and instruments
Complete assigned tasks in a timely manner
Conduct daily activities in an organized, efficient manner
Perform simple, routine, complex, and critical operations
Troubleshoot equipment issues, when necessary
Ensure process equipment is appropriately maintained for operation
Perform and document operations in accordance with cGMP’s
Execute equipment qualification protocols and validation protocols
Routinely draft and revise standard operating procedures and master batch records
Recognize and initiate process deviations
Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
Embrace Alexion Core Competencies
Train other staff
Communicate effectively, written and verbal
Maintain training compliance
Ensure a safe working environment for all staff
Review batch records and other manufacturing process records
Plan daily activities and schedule operations
Perform deviation investigations and closure
Interact with other departments
Perform data collection, compilation, and statistical analysis
Become technical expert on select equipment or processes
Interact with vendors and outside resources
Complete assigned projects
May act as shift lead, providing instruction to the team
Must be able to work within and adapt to complex electronic systems such as SAP and Trackwise
Must have good working knowledge of MS Excel and Word
Ability to work in an intense, fast-paced work environment
2-5 years experience in a cGMP biopharmaceutical manufacturing environment

Manufacturing Associate Resume Examples & Samples

Be the shift lead, providing instruction to the team
Troubleshoot and resolve operational problems during processing
Represent Manufacturing in cross functional initiatives and meetings
Monitor and evaluate process trends and recommend and implement continuous improvement strategies as appropriate
Manage multiple projects independently
Plan and implement complex changes
Technical expert for entire area(s)
Interact independently with regulatory agencies
Develop and provide training on complex manufacturing processes
Perform Manufacturing review and approval of critical documents
Develop process validation protocols
Analyze complex problems and determine and implement solutions
More than 8 years experience in a cGMP biopharmaceutical manufacturing environment

Manufacturing Associate Resume Examples & Samples

With senior manufacturing personnel, executes all routine operations in the manufacturing of the Company's RPE product
Operate and ensures proper maintenance of BSC's, microscopes, incubators, centrifuges, pH meters, and other manufacturing equipment
Able to perform aseptic technique in a biological safety cabinet, media changes, cell passaging and in-process testing
Initiate Document Change Requests; author, revise and review manufacturing documentation
Reports any issues related to manufacturing performance, process and safety to management in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement
Flexible hours dependent on Manufacturing schedule with some weekend work required
BA degree with focus on Biologics and 4+ years of experience
Production/Processing - Knowledge of raw materials, production processes, quality control, and other techniques for maximizing the effective manufacture of pharmaceutical products. Includes advanced knowledge of aseptic technique and basic lab instruments, (Centrifuge, Pumps, Scales, etc.)

Manufacturing Associate Resume Examples & Samples

Participate in all aspects of manufacturing including but not limited to: preparation of buffer solutions, product manufacturing, filling, and labeling
Cleaning and sanitization of parts and equipment
Cleaning and disinfecting manufacturing rooms
Transferring product, equipment, and components within the CNC and ISO classified areas
Stocking production area with supplies
Executing process steps according to defined SOPs and batch records
Documenting activities in accordance with cGMPs
Following accurate verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation
Maintaining cleanliness and orderliness of operational area
Preparing or revise cGMP required documents
Identifying process and quality problems and following corrective actions
Demonstrating knowledge and understanding of GMPs and how they apply to specific responsibilities
Communicating progress effectively
Maintaining a safe working environment
Following company policies and procedures
BA/BS with 0-1 years of relevant experience or high school diploma/GED with 0-2 years of relevant experience
Proficient in Microsoft-based computer software programs: Word, Excel, and Google applications such as Mail and Drive
Effective writing and verbal communication skills
Able to work flexible schedules on a short notice

Manufacturing Associate Resume Examples & Samples

Revision of cGMP documents
Handling/completion of batch documentation
In process measurements and aseptic sampling
Execution of validation protocols
Read and understand work instructions (in English)

Manufacturing Associate Resume Examples & Samples

Perform antibody conjugation and purification
Follow SOPs to perform experiments. Use ERP database and other database to document activities
Set up production specification for manufacturing
Trouble-shooting problematic conjugations with emphasis on optimizing reaction conditionSkills

Manufacturing Associate, / Ii-purification Resume Examples & Samples

Following Standard Operating Procedures (SOP’s)
Effectively advance multiple projects simultaneously
Perform all essential functions related to antibody purification manufacturing including: centrifugation, making buffers, using the spectrophotometer, running SDS-PAGE gels, and performing endotoxin tests
Performing basic math calculations to calculate concentration and amounts of antibodies
Performing column chromatography manually as well as using FPLC
Using the ERP database to execute production orders
Maintaining laboratory equipment and supplies
BS degree in Biochemistry, Biology, Chemistry, or Related Science
1-5 years of industry experience in antibody purification or protein purification
Basic understanding of antibody structure and how various chromatography methods work
Hands-on experience with column chromatography is a must
Strong organizational, documentation, and communication skills
Must be able to take initiative and be flexible, highly motivated, and dependable
Good computer skills are required
Experience with automated purification systems is strongly desired
Previous experiences with automated purification system such as AKTA is a plus

Manufacturing Associate Resume Examples & Samples

Contributes to design meetings such as operability and 3D modeling reviews. Understands current Biological Manufacturing processes enough to suggest improvements to Safety and Efficiency. Understands how equipment should operate and assist in design of the process automation
Writes/contributes to functional specification documents and participates in creation of commissioning and or validation protocols necessary for plant start up. Writing of relevant SOP’s or manufacturing batch records to support new processes
Assemble and procure manufacturing related items needed in processing suites, laboratories, or the warehouse in order to organize and efficiently run the facility
Actively participates in creating training for manufacturing staff to include cGMP operations as well as safety
Able to work independently as well as in global cross functional teams
Executes or directs FAT protocols without the need for supervision
Assignments are complex in nature where considerable judgment and initiative are required in resolving problems and developing recommendations
A comprehensive acquaintance with and understanding of both general and specific aspects of the job and their practical application to complex problems and situations ordinarily encountered in the functional area
Full understanding of subject processes, technology/science of functional area
Applies time management and job skills in accordance with company policies and procedures to complete a range of moderate to complex tasks
Possesses a thorough understanding of the manufacturing process, including manufacturing support activities. Has strong technical knowledge, including understanding relevant engineering and scientific concepts
Possesses strong technical understanding of equipment function, application and procedures, and identifies potential process and equipment improvements. Understands the theory and concepts behind the process, including an understanding of the impact of their own area on upstream and downstream activities
Knowledgeable on routine and non-routine process occurrences. Recognizes potential process and equipment problems. Understands implications of test/process specifications, operating ranges, alert and action limits. Able to apply understanding to avoid potential issues
Writes new SOPs and edits existing SOPs
Understands basic biotechnology processing - purpose of major unit operations and microbial control concepts
Reviews/creates validation protocols. Possesses strong understanding of validation concepts
Understands validation SOPs and the impact of validation on cGMPs and production

Manufacturing Associate Resume Examples & Samples

Demonstrates knowledge and understanding of GMPs and how they apply to specific responsibilities
Follows accurate verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation
Identifies, escalates and documents events that deviate from normal operation; participate as needed in investigations
Maintains cleanliness and orderliness of operational area
Performs all operations in assigned operational area
Monitors operations to ensure compliance with process specifications
Demonstrates ability to troubleshoot basic mechanical operations
Effectively utilizes Microsoft office applications

Manufacturing Associate Resume Examples & Samples

Operate manufacturing equipment in strict accordance with SOP’s to complete task in support of cell culture operations
Perform Component Weighing, batching of media and buffer, sterile filtration and aseptic technique in a CGLP manufacturing facility
Routine production of media and buffer at 25L – 2000L scale
Perform CIP for media preparation tanks (Nalgene and stainless steel tanks)
Perform the set-up of process equipment
Assist in the review of document records for completeness and accuracy
Operate complex systems and equipment in strict accordance with SOP's, and safety guidelines
Operate the autoclave and perform autoclaving solutions and equipment
Assist in implementing of production procedures to optimize manufacturing processes
May participate in plant trials for evaluating process modifications
May provide training to new personnel in all areas of Media Prep and CCCD activities
Troubleshoot processing problems
Maintains all associated documentation for operations being perform
Accurately complete batch records and logs sheets
Monitor and maintain laboratory equipment operation
Requires an Associate’s degree and 3-5 years of experience or Bachelor's degree and 1-3 years of experience with cGLPs/GMPs in biotech or pharmaceutical industry and a minimum of 3-5 years’ experience with buffer, media and equipment preparation. Requires ability to lift up to 25-45 pounds
Should be able handle multiple tasks simultaneously
Experience reviewing and creating documents
Self-motivated and have excellent organization, communication and computer skills

Senior Manufacturing Associate Resume Examples & Samples

Practices and promotes safe work habits and adheres to Genzyme's safety procedures and guidelines
Maintains cleanliness and orderliness of process area
Maintains production area with supplies
Performs batch record review, procedure revisions, and work order generation
May be responsible for training less experienced or new operators
May be designated as a lead operator on manufacturing operations
Fulfills role of lead trainer on numerous operations and is an area SME
Mentors less experienced operators and performs support function for supervisor
Leads teams to the execution of the daily work plan
May attend scheduling and MDI meetings in absence of supervisor
High school diploma/GED with 5-7 years of experience in cGXP manufacturing environment, or Bachelor's degree with 3-5 years of experience
Bachelor's degree with 4-6 years of experience in bulk biologics cGMP manufacturing
Familiarity with Manufacturing Control Systems (i.e. DeltaV)
Extended experience in large-scale purification operations
Experience reviewing and creating controlled documents
Experience in column packing and qualification
Experience in leading teams

Senior Manufacturing Associate Resume Examples & Samples

Practices and promotes safe work habits and adheres to Genzyme’s safety procedures and guidelines
Ensures production area is stocked with supplies
Performs batch record review, procedure revisions and work order generation
May lead shift handover or act as a shift lead in the absence of a supervisor
High School Diploma/GED with 5-7 years in cGXP manufacturing environment, or Bachelor's degree with 3-5 years of experience
Experience on-the-floor leadership or "subject matter expertise" in Cell Culture operations
Familiarity with deviation management systems (i.e. Trackwise)

Manufacturing Associate Resume Examples & Samples

In compliant with Milford’s Environmental Monitoring program, perform aseptic clean sampling of biological processes, gas and water systems. Samples to be submitted to QC lab for testing that includes viable, total particulate air, oil content, and moisture
Perform viable surface plating, total particulate and viable air sampling using Particle Counter and Microbial testers with media plates
Author, revise, or prepare documents (SOPs, BRs, Forms, Job Aids) to assist in the implementation of measures that will minimize the number of exceptions occurring in the department
Update SOP manual binders on the production floor, order batch production records, review batch production forms and logs, maintain and archive production records in coordination with quality
Operate cleaning/sanitization systems (such as glasswasher and autoclave, etc). Manually clean portable equipment and small parts
Provide support for on-the-floor production activities through the provision of documents, supplies, gowning, disposables, materials and kittingas requested
Operate Manufacturing process equipment (such as robot, portable mixers, chromatograph, etc.) Assemble and operate filtration and chromatography systems
Monitor and record batch parameters, including computer data entry. Complete relevant paperwork following GDP/GMP guidelines
Perform mathematical calculations related to production processes
Perform routine maintenance and cleaning of production equipment to ensure equipment remains GMP compliant
Participate on Continuous Improvement Teams (such as 5S, Gemba, etc.)
With high school diploma: Minimum of 4 to 6 years of related experience required
With Associate’s degree: Minimum of 2 to 4 years of related experience required
With Bachelor’s degree: Minimum of 0 to 2 years of related experience required
Knowledge of cGMP manufacturing preferred; BS-level indidivuals without previous GMP experience will be trained
Able to perform aseptic samplings independently according to schedule
Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: air samplers, autoclaves, process tanks, incubators, analytical equipment

Manufacturing Associate Resume Examples & Samples

Performs/ assists with Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record, SLR and control system
Actively participates in training activities, managing their individual training plan
Is able to execute validation protocols relatively independently
Utilizes Manufacturing knowledge to train others, improve process operations and affect positive change and demonstrates ability to troubleshoot moderate to complex mechanical operations
Proficient and knowledgeable in the operation and moderate to complex troubleshooting of two or more manufacturing area’s
Supports deviation investigations and participates in cross functional project teams, supports technical transfers with relevant teams/ individuals
Good knowledge of current Good Manufacturing Practices (cGMP’s). Working knowledge of all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups
Has a good understanding of cGMP Biotech or Pharmaceutical operations
CGMP: Understands cGMP requirements and follows those requirements, including requirements for good documentation practices
Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups)
Possesses good knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management
Possesses a thorough understanding of the scientific theory of biologics manufacturing
Has a good understanding of biotechnology processing - purpose of major unit operations and microbial control concepts
Actively pursues learning of required skills, new skills, and new equipment
Understand routine procedures upon which they have been trained, is able to revise and create new procedures
Possesses good equipment understanding, including understanding equipment function and application
Ability to train less experienced or new manufacturing associates
Supports deviation investigations. Participates in cross functional projects teams, supports technical transfers with relevant teams/individuals
Proficient in MS Office and related PC skills

Manufacturing Associate Resume Examples & Samples

Performs Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record, SLR and control system
Completes /reviews validation protocols, deviation reports, change controls in accordance with cGMP’s
Performs the weighing, dispensing of raw materials for media and buffers
Performs the preparation of small and large volume media and buffer solutions, filtration and transfer of product
Operates bench top equipment including pH, conductivity, osmo meters, pumps, tubing welders , filter integrity testers etc
Dispensing, labeling, transfer/staging of raw materials and parts
Assembly/disassembly, cleaning and sterilization of components, parts and equipment
Maintaining equipment, area and cleaning logbooks
Cleaning sanitizing production rooms and equipment,
Stocking production and cleaning supplies
Author/ review/improve SOP’s, batch records, protocols and technical reports
Utilizes Manufacturing knowledge to train others, improve process operations and affect positive change and demonstrates ability to troubleshoot basic mechanical operations
Proficient and knowledgeable in the operation and basic to moderate troubleshooting of at least two manufacturing areas
Advanced knowledge of current Good Manufacturing Practices (cGMP’s). Working knowledge of all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups
Experience with cGMP Biotech or Pharmaceutical operations
Possesses advanced knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management
Possesses advanced understanding of the scientific theory of biologics manufacturing
Understands biotechnology processing - purpose of major unit operations and microbial control concepts
Understand routine procedures upon which they have been trained
Possesses advanced equipment understanding, including understanding equipment function and application
Proficient and knowledgeable in the operation and basic to moderate troubleshooting of at least two manufacturing area

Manufacturing Associate Resume Examples & Samples

Is able to execute validation protocols relatively independently after training and instruction
Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area
CGMP: Understands basic cGMP requirements and follows those requirements, including requirements for good documentation practices

Manufacturing Associate Resume Examples & Samples

Bachelor (B.S.) or equivalent education or experience required
Must be able to learn to gown for a class 10,000 cleanroom
Must be able to learn how to operate in a GMP production environment with aseptic technique
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. The ability to write routine reports and correspondence. Finally, the ability to speak effectively before groups of customers or employees of organization

Manufacturing Associate Resume Examples & Samples

*This is a temp to perm position***
1) Performs standard manufacturing tasks, such as: electromechanical assembly operations, soldering, testing, packaging and verifying the quality of parts, assembles and finished drives, servos and motion control products. Performs modular troubleshooting, rework and repair
2) Operates manufacturing machines and test equipment utilizing appropriate gauging and tooling to adjust the equipment while applying judgment to assure conformance to specifications. Performs standard setups
3) Completes process data accurately
4) Performs preventive maintenance. Daily keeps work area clean and functional
5) Performs material handling functions including MRP data entry to maintain raw material and WIP inventory accuracy
6) Completes miscellaneous duties as assigned

Manufacturing Associate Direct ECT Resume Examples & Samples

Adhere to all personal protective equipment and safety requirements
Ability to operate machinery and perform changeovers, as needed
Assemble components into machined valve body
Reset faults, as appropriate
Perform visual inspections and identify potential quality concerns
Perform lot control and tagging of components, work in process, and/or finished goods
Complete check sheets and reports, as necessary
Retrieve and unpack components and stock the line
Pack parts into dunnage
Operate pallet truck to move material and dunnage
Clean cell and area
Use hand gages and/or other testing devices to perform quality checks

Manufacturing Associate Resume Examples & Samples

Operates production machinery according to specifications and makes adjustments to machinery to correct problems or errors
Inspects work pieces
Fills out hr by hr boards and any other related documents
Cleans and lubricates production machinery
Uses judgment and initiative to solve problems

Manufacturing Associate Resume Examples & Samples

Follow SOPS, maintain batch records, and analyze lot histories
Prepare buffers and dilutions
Perform dialysis and centrifugation
Pipetting and use of pH meter and UV-VIS spectrophotometer
Perform basic math calculations to calculate amounts of antibodies and concentrations
Perform column chromatography and agarose gel electrophoresis
Use of ERP database
Basic understanding of IgG antibody protein structure
Basic understanding of how antibody conjugation is performed
1-3 years of relevant lab experience related to antibody purification and conjugation

Manufacturing Associate Resume Examples & Samples

Responsible for implement of the required production plan
Follow up and implementation the manufacturing / quality processes
Strict Follow up working instruction (FBI)
Timely raise any non-conforming issues to team leader and supervisor
Strict follow up production procedures
Strict follow up DMC process
Responsible for use tools correctly for production
Involve process improvement activities
Maintain quality standard that include Class A, FTT, OOBQ, lean assessment etc and Quality Management System ISO9000/14000
Have 1+ experiences working in a factory in a team environment
Good operation build skill
Strong initiative for learning
Good team work and co-operation
Have problem analysis and solving skill 6. Good PC knowledge in Microsoft Excel and Word 7. Prefer to have ability for both spoken and written English

Plastics Manufacturing Associate Resume Examples & Samples

Must be able to multitask
Able to operate 3-5 presses
Must communicate effectively, sharing accurate and complete information/ideas using courtesy, tact, and correct grammar
Must be able to work in a fast paced environment, while maintaining quality and safety standards
Excellent communication & training skills
Able to read and understand detailed instructions and procedures
Preferred experience with ISO and GMP standards and practices
Knowledge of Microsoft Office (Outlook, Excel & Word)
Able to stand, bend and/ or kneel per job requirement
Ability to lift up to 45 lbs
High School diploma/GED equivalent, preferred 0-2 years of Manufacturing Associate experience

Mars Petcare Manufacturing Associate Resume Examples & Samples

Performs all assigned activities and job tasks with a line or area
Operates equipment in a safe and efficient manner
Takes corrective action in solving problems to root cause level
Assess equipment operating reliability and perform routine repairs, adjustments and malfunction troubleshooting
Performs and /or works with Maintenance to complete equipment preventive maintenance
Maintains accurate records of QC checks, production numbers or waste performance
Performs all shift support documentation in a quality matter
Perform Quality Control tasks such as metal checks, inspection of date codes, item numbers, dump logs, etc
Demonstrates high degree of ownership for product quality:Performs all standard checks & other quality related duties
Understands production schedules, production computer systems, work instructions and production inventories
3+ years of manufacturing experience operator a variety of machines is a plus
2 years of work experience within manufacturing or a technical and or trade discipline is desired
Demonstrated competency in computer and pc software including MS office and email
Knowledge of inventory control principles
Ability to stand on a concrete floor
Wearing proper personal protective equipment (hair net, bump cap, ear plugs, safety shoes, and uniform)
Bending, stooping, twisting, turning, standing for extended periods of time, reaching, climbing stairs, and lifting
Must be able to adapt to temperature and environmental extremes such as hot to cold, dust, dirt and chemicals
Have a high school diploma, GED or equivalent education
Must be willing and able to work and accept varying shifts and schedules
Ability to understand and effectively communicate in the English language

Lead Manufacturing Associate, Cell Culture Resume Examples & Samples

Operate and train others in the use of manufacturing process equipment to perform various productions steps such as
Expansion of cells in roller bottles and flasks
Automated and manual cell culture systems supporting cell growth, expansion, and harvesting systems
Viral inactivation mixing systems
Execute manufacturing operations that require the operation of BSC’s, microscopes, incubators, mixing equipment, automated cell culture harvesting equipment, conductivity meters, autoclaves, and other manufacturing equipment
Perform purification processes such as filtration and chromatography
Train and mentor other team members and monitor training for newer team members
Provide guidance regarding GMPregulations and may make recommendations regarding their interpretation
Interface with other departments (such as Maintenance, Metrology, Validation) to resolve issues related to equipment, process, compliance
Complete required documentation and guide other operators on proper GMP recording of entries and comments in batch records, forms and protocols. Perform documentation reviews and revisions
Resolve issues related to equipment, process and compliance. Act as “go to” person for troubleshooting. Investigate any process problems in a timely manner and provide documentation
Assist with process/equipment validation and data analysis
Represent Manufacturing department in cross functional teams as necessary
Serve as a leader on Continuous Improvement Teams (such as 5S, Gemba, etc.)
With Bachelor’s degree: 3-5 years of related GMP manufacturing experience required
With Associate’s degree: 5-7 years of related GMP manufacturing experience required
With high school diploma: 7-9 years of related GMP manufacturing experience required
Knowledge of cGMP manufacturing and in-depth process knowledge of cell culture processes
Thorough knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems
Proficiency in a variety of mathematical disciplines and able to work with both the metric and USA standards of measurement and military time. Must be able to apply quantitative analysis to analyze process performance
Able to read and follow detailed English written instructions and have good verbal/written communication skills. Good procedural writing skills
Able to record in records legibly and grammatically correctly
Good computer skills, knowledge of Microsoft Word, Excel, Visio
Able to meet schedule requirements; this position includes shift, weekend, holiday work and overtime at times

Temporary Manufacturing Associate Resume Examples & Samples

Demonstrate excellent understanding of cGMPs and other relevant regulations (e.g. environmental etc.)
Be responsible for following SOPs, policies and other necessary procedures to ensure successful operation of the drug product facility
Interface with Materials Management and the Release and Stability Laboratory to coordinate the purchase and delivery of necessary materials and the testing of routine cleaning and release samples
Monitor development scientists to assure they operate effectively in a cGMP environment
A bachelor’s degree or 2+ years with solid oral dosage experience
Ability to build excellent understanding and application of cGMPs and other appropriate regulations to ensure successful operation of a dual use (development and commercial) drug product facility (including authoring SOPs, policies etc.)
Inventive and innovative, self-starter who is comfortable and successful working in a multi-disciplinary team under defined timelines

Manufacturing Associate Resume Examples & Samples

Technical Skills – Developing
Troubleshooting – Developing
Theoretical Knowledge - Basic knowledge of chemicals and laboratory equipment
Written Communication - Able to document process and successfully uses GDP
Interpersonal Communication - Demonstrates appropriate communication within the department and to supervisor
Presentation Skills – Developing
Sphere of Influence – Developing
Leadership – Developing
Planning – Developing
Processing Capabilities - Able to perform operations with oversight
Project Performance - Able to constructively participate in projects affecting the local department
Training - Proactively seeks opportunities to learn new skills
Continuous Improvement - Participates in continuous improvement initiatives

Manufacturing Associate Resume Examples & Samples

Packages and labels disposable products based on weekly forecasts and load requirements
Ensures all labeling is correct based on Engineering Drawings and Packaging Inserts
Able to stand for long hours working in a controlled environment
Performs visual inspection of disposable products in accordance with written procedures
Performs packaging integrity testing of disposable products in accordance with written procedures
Completes all information required by the Workorder and notifies Supervisor if information is missing or incorrect
Special projects as required by the Department Manager/ Supervisor or business needs
Must be detail oriented and a self starter
Able to work in a team environment and follow verbal and written instructions
Must be able to work overtime as required to support business needs and have good attendance
Good hand eye coordination and mechanically inclined

Manufacturing Associate Resume Examples & Samples

Maintains operational areas by ensuring that manufacturing clean rooms are neat and orderly in accordance with cGMPs
Follows Good Manufacturing Practices and maintains a current GMP document-training log
Ensures that equipment used in the GMP facility are in working order and are properly maintained
Makes sure that there is a minimum inventory level of standard stock materials
Ensures that all gowning supplies are restocked as required so manufacturing operations are not interrupted
Formulates buffers and media in accordance to established procedures for use in GMP operations
Filter integrity testing utilizing Sartocheck 3 Filter Integrity Tester
Operate and maintain Autoclave (19 cu ft)
Operate and maintain Gruenberg Oven (15 cu ft)
Assists Manufacturing Associates with production processes
Trains new technicians on required processes and procedures
Complies with all safety policies, practices and procedures
Reports all unsafe activities to supervisor and/or Human Resources
Participates in proactive team efforts to achieve departmental and company goals
Associate's degree (A.A.) or high school degree required
A minimum of one to two years related life sciences industry experience
Require experience working in a GMP production environment with aseptic technique
Must be able to gown for a class 10,000 cleanroom environment and work under aseptic conditions in a class 100 environment

Aseptic Manufacturing Associate Resume Examples & Samples

High School diploma or equivalent required. BS preferred, additional experience in lieu of degree considered
Knowledge of cGMP practices preferred
Proactive communication

Manufacturing Associate Resume Examples & Samples

Acts as subject matter expert for a specific piece of equipment
Routinely implements production and manufacturing procedures
Accurately documents data and writes/reviews batch records under cGMP guidelines
Reliably executes and writes well defined SOP’s and manufacturing batch records. Initiates and writes revisions to current GMP/SOP guidelines

Temporary Manufacturing Associate Resume Examples & Samples

Undertake to perform the assigned tasks in a safe manner
Manufacture of the Company’s products to exacting standards of cGMP
Accurate and legible completion of batch paperwork
Obtaining clearance before commencing batch runs

Manufacturing Associate Resume Examples & Samples

Operate process equipment under strict adherence to cGMP, OSHA and United Therapeutics' policies and regulations
Perform basic trouble-shooting, assist with technical issues
Receive and handle production raw materials
Write area SOPs
Work on problems of moderate scope
This individual should have strong written and verbal communication skills
Team player committed to quality and working effectively
Good professional documentation skills
Ability to objectively, accurately, and thoroughly convey complex issues in writing
Ability to interact with other departments effectively

Manufacturing Associate Resume Examples & Samples

Operate bioprocess equipment under strict adherence to cGMP, OSHA and Unither policies and regulations
Maintain and prepare production documentation
Assist with technical issues and problems
Scale-up and basic trouble-shooting, assist with technical issues
Ability to work effectively in a team

Manufacturing Associate Resume Examples & Samples

Assists with Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record, SLR and control system
Executes validation protocols under supervision/direction of others
Recognizes and performs scheduled tasks
Understand routine procedures upon which they have been trained. Possesses basic equipment understanding, including understanding equipment function and application

Manufacturing Associate Resume Examples & Samples

BS/BA degree in biological science or related field
2+ years of previous experience in a chemistry, molecular biology and/or biochemistry setting
A strong working knowledge of standard laboratory techniques of molecular biology is required (PCR, DNA and RNA isolation, bacterial transformations, microarray assays)
Strong oral and written communication, organization, team building and computer skills essential

Manufacturing Associate / Blender Operator Resume Examples & Samples

Operates and ensures proper operation of manufacturing equipment
Conducts regular in-process checks of quality attributes of materials and products and to ensure the equipment is operating correctly
Assists in recording accurate production and inspection data and is responsible for completing manufacturing paperwork in compliance with required SOPs and cGMPs
Performs set ups, changeovers and cleans the work area throughout the shift to ensure proper clearance of materials
Continuously looks for and helps to implement improvements to the process, productivity, quality and reduce costs
Performs other related duties as assigned
High School Diploma or Equivalency required
Must possess basic math and reading comprehension skills and be able to read, speak and comprehend instructions in English, including procedure documents, as well as proofread alpha and numeric data
Requires ability to follow standard work and Standard Operating Procedures (SOPs)
Basic computer skills and the ability to navigate through computer based training systems and use in the course of daily work may be required
Must be able to communicate effectively as a member of a work team
Must meet all locally defined training requirements
Experience in a pharmaceutical, Federal Drug Administration (FDA) controlled, other controlled regulatory agencies, or Current Good Manufacturing Practices (cGMP) packaging or manufacturing environment is preferred
Required to operate and handle material handling equipment
Ability to work overtime as required

Manufacturing Associate Resume Examples & Samples

Install leads, bushings, tap changers and accessories
Install and fabricate buss bars and various copper connections
Fabricate internal leads and lugs
Operate vacuum pump equipment
Perform simple wiring diagnostic testing
Installation of external chambers and conservator units
Rotate mandrel and wind coil using foot pedal
Guide strap/wire with 2 hands onto coil as mandrel turns
Use mallet to hammer strap into place as mandrel turns
Load wire reel to spool rack
Work on adjustable platform
Shot blast to remove scale, slag and dirt from tanks and parts
Set up and operate machines such as press brakes, shears, rolls, drills and saws
Load/unload tractor trailers using forklifts and dolly
Deliver parts and materials to factory floor and other designated areas
Sanding and touch up painting of transformer
Perform simple winding operations
Wiring of control cabinet accessories, switches and components
Perform finishing, pressure tests and assemble work on transformers
Comply with all job-related safety requirements
Additional duties may be assigned, as required
6+ Months experience in a manufacturing environment
2+ years of comparable experience working in a manufacturing environment
Forklift operation certification
Crane and hoist training
Experience working in confined spaces
Proven basic math skills and the ability read measurement tools
Ability to read a blueprint and know the meaning of a dotted line and a solid line
Understanding of a manufacturing environment, terminology, and processes
Technical background is a plus
Local candidates are preferred – no relocation assistance will be provided

Manufacturing Associate Resume Examples & Samples

Operates in a safe manner in order to avoid injury to self and others
Basic investigational skills trending Delta V parameters
Follow cGMPs to document data and information in Batch Production Records, Solution Lot Records and equipment logbooks as instructed
Actively participates in and manages their individual training plan
Interacts with others in a professional and courteous manner in accordance with Biogen’s Core Behaviors

Manufacturing Associate Resume Examples & Samples

Must be able to perform the qualifications of a Manufacturing Associate I
Technical Skills – Comfortable with set-up and operations, daily maintenance, and break down of simple/routine equipment. Qualified to perform CIP, SIP autoclave, small parts preparation. Able to identify processing gaps and assist with implementation of new technologies. Has access to JDE and understand how to create facility Work Orders
Troubleshooting – Proficient at troubleshooting minor to moderate problems. Understands when and to whom to elevate
Theoretical Knowledge - Understands the scientific and technical background associated with areas they are performing
Written Communication - Able to draft simple to moderate DCRs and complete minor NCR investigations
Interpersonal Communication - Communicates professionally within and outside of the department
Presentation Skills – Able to present clear-cut concepts to local group
Sphere of Influence – Able to influence within the operational group
Leadership – Able to lead group through a major process step
Logistics - Understands systems for purchasing routine items. Able to procure items and supplies
Planning – Consistently understands and provides feedback for operations occurring within the current work week
Processing Capabilities - Takes the lead during processing steps. Prepares the shift for upcoming processes
Project Performance - Able to lead a department team or moderate project with oversight. Consistently works as a project team member on Kiazen and other improvement initiatives
Training - Can successfully train newer team members on routine processes
Continuous Improvement - Actively performs as equipment and room owner. Applies 5S and TPM as required to improve area

Manufacturing Associate Resume Examples & Samples

Manufacturing of Master and Working Cell Banks, Cell & Gene Therapy products, and/or final product fills
Interact with Engineering, Facilities, Validation, Quality Assurance, Quality Control, Project Management, and Materials Management groups. As needed, further interaction will be required with material/equipment vendors and commercial partners
Responsible for activities required for successful operation of assigned project area including: ensuring batch production activities follow all documentation and Standard Operating Procedures (SOPs)
Contributes to overall scientific rigor through objective laboratory investigation
Cleans process suites and equipment
Reviews and signs logbooks
Conducts development projects and verification runs from inception to completion
Prepares and revises technical documents and reports
Communicates status of operations, safety and maintenance problems, in a timely manner to Area Management
Participates in internal meetings as appropriate
Monitors and communicates inventory needs to company’s Materials Management group
Initiates deviations/investigations
High School diploma and at least 3 years in cell production/biologics facility or Bachelor’s degree with major in Biology, Chemistry or related Science major and 2 - 3 years of experience in cell production/biologics facility or equivalent
Experience in aseptic processing techniques and some understanding of regulatory requirements for a cGMP manufacturing facility is required
Ability to work under limited supervision at times and to handle problems

Manufacturing Associate Resume Examples & Samples

Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record, SLR and control system
Documents/Records and Reviews cGMP data and information for processing steps and/or equipment activities, following standard operating procedures. Revises documents as instructed. Key documentation includes batch records, SLRs, and equipment logbooks and support of deviation filings and root cause analysis activities. Capable of minor equipment and/or process changes
Actively participates in training activities, managing their individual training plan. Trains other associates as required

Senior Manufacturing Associate Resume Examples & Samples

Lead shift during purification operations
Mentor new recruits and assist in staff development and training
Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems
Identify the technical, procedural and equipment issues that hinder production and compliance. Inform support departments and manager as needed. Ensure equipment and materials are in place as required for each production run
Antibody and enzyme purification via Affinity chromatography, Size Exclusion chromatography, Ion Exchange chromatography, Hydrophobic Interaction and Tangential Flow Filtration (TFF)
Plan and prepare needs for processes and activities
Pack, unpack, and clean production scale chromatography columns
Operate and maintain BioProcess chromatography skid
PH and conductivity meter calibration and testing
Aseptic technique utilizing excellent hand skills with slow, deliberate movement
Product filtration (sterile filtration, ultrafiltration, viral filtration)
Product filling (aseptic processing including media fill qualifications)
GMP documentation
Revise and initiate Batch Production Records, Standard Operation Procedures, study protocols and reports
Control and track raw material inventory
Maintain and clean cleanroom facility and equipment
Manually clean small parts and equipment
Filter integrity testing utilizing Sartocheck 3/4 Filter Integrity Tester
Operate and maintain ARS Autoclave
Perform daily monitoring of equipment
Prepare glassware and equipment for production
Related Bachelor's degree (ie Biology, Biotechnology, Chemical Engineers) plus 2 - 5 years cGMP mammalian and/or fermentation cell culture experience
Preferably, experience working with new products in a pilot or manufacturing facility and/or assist in process development of clinical products
Need two years of experience working with liquid chromatography columns or similar equipment
Highly desirable: experience working in a GMP production environment with aseptic technique

Senior Manufacturing Associate Resume Examples & Samples

Perform daily monitoring of equipment in pilot and manufacturing facilities
Cell culture expansions and aseptic techniques (thaw cell banks -1mL vial through cell culture expansion and maintenance - up to 36L spinner flasks performed in a BSC)
Operate and maintain equipment - NOVA analyzers, pH meters, CO2 analyzers, pH and DO simulators, microscope, pipettors, Vi-Cell cell counter, and CIP skid
Harvest operations - pod filtration and TFF system
Operate Sartocheck filter integrity testers
Revise and initiate Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and forms
Collaborate with other departments for raw materials, testing requirements, documentation, validation, maintenance, and scheduling
Ensure that equipment and material are available as required for each production run
Identify the technical, procedural, and equipment issues that hinder production and compliance. Inform support departments and manager as needed
Assist in the transfer of technology from process sciences (PS) and MSAT to cGMP Manufacturing
Assist with periodic technical and compliance investigations, inspections, and audits
Report all unsafe activities to manager and/or Human Resources
Communicate with team members, supervisors and members of other departments, as appropriate, to assure prompt resolution of problems
Ability to train other associates with assigned tasks
Operate and maintain Getinge Autoclave and Gruenberg Oven
Prepare media and buffer
Perform aseptic filling
Proficient in personal computer skills, including e-mail, record keeping, routine database activity, word processing, spreadsheets, and graphics
Ablity to handle, prioritize, and lead multiple tasks and projects simultaneously

Lean Manufacturing Associate Resume Examples & Samples

Adhere to all company policies
Perform assembly using established assembly and/or test procedures and written instructions
Meet Lean Manufacturing Competencies

Manufacturing Associate Resume Examples & Samples

This is a 6 month temporary position**
Performs standard manufacturing tasks, such as: electromechanical assembly operations, soldering, testing, packaging and verifying the quality of parts, assembles and finished drives, servos and motion control products. Performs modular troubleshooting, rework and repair
Operates manufacturing machines and test equipment utilizing appropriate gauging and tooling to adjust the equipment while applying judgement to assure conformance to specifications. Performs standard setups
Completes process data accurately
Performs preventive maintenance. Daily keeps work area clean and functional
Performs material handling functions including MRP data entry to maintain raw material and WIP inventory accuracy
Completes miscellaneous duties as assigned

Lead Manufacturing Associate Resume Examples & Samples

Knowledge of cGMP manufacturing and in-depth process knowledge of cell culture and/or purification processes
Thorough knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical (HPLC) equipment and CIP/SIP systems
Good computer skills including Microsoft Word and Excel
Demonstrated interpersonal and leadership skills and be able to lead a work team effectively and efficiently in a team environment
Able to meet schedule requirements. This position schedule is four 10-hour days (Sunday-Wednesday) and may include additional weekend, holiday work and overtime at times

Manufacturing Associate Resume Examples & Samples

Performs clean in place operations to prepare equipment for manufacturing operations
High school diploma/GED with 3-5 years of experience in cGXP manufacturing environment, or Bachelor's degree with 1-3 years of experience
Bachelor's degree with 2-4 years of experience in bulk biologics cGMP manufacturing
Experience in a GXP environment
Experience facilitating and delivering training
Experience creating controlled documents
Experience in Lean manufacturing and MDI (management for daily improvement) participation

Manufacturing Associate Resume Examples & Samples

Executing daily tasks such as washing and sterilizing vials and filling components for use in production operations, the inspection of filled, labeled and packaged vials and performing facility and equipment cleaning according to standard operating procedures
Recording activities in batch documentation and equipment logbooks according to good documentation practices as well as updating and/ or authoring Standard Operating Procedures to optimize production processes
Timely reporting of equipment malfunction to manufacturing management
Maintaining an inventory of manufacturing supplies and ordering additional materials as necessary
Assisting in activities related to other onsite departments such as the execution of validation protocols
Other duties as assigned by manufacturing management which contribute to the overall success of the site

Manufacturing Associate Resume Examples & Samples

Prepare large scale components and equipment for GMP production
Perform clean in place and sterilization operations to prepare equipment for manufacturing operations
Escalate issues to a supervisor or higher level co-worker
Review and create operation documents and batch records
Identify subtle variances from typical manufacturing operations; communicate to a supervisor and other support groups
Facilitate and execute daily work plan
May be responsible for batch record review, as a delegate
Effectively demonstrate understanding of cGMPs and how it applies to specific responsibilities
Follow written procedures in operating production equipment and performing processing steps
Maintain orderliness of process area
Maintain production area with supplies
Monitor operations to ensure compliance with process specifications and SOPs
Complete process documentation in accordance with good documentation practices (GDP)
Practice and promote safe work habits and adheres to Genzyme’s safety procedures and guidelines
Work under direct supervision to a supervisor or a shift lead
Perform support function for more senior operators
Utilize manufacturing knowledge to improve process operations and affect positive change
High school diploma, Biotech Certification with 3-5 years in a cGMP manufacturing environment, or
Associate’s Degree or equivalent and 1+ years of experience in a cGMP manufacturing environment, or Bachelor’s Degree in science related field with 1-2 years experience

Manufacturing Associate, Cell Culture Resume Examples & Samples

With senior manufacturing personnel, executes all routine operations in the manufacturing of the Company's RPE product
Operate and ensures proper maintenance of BSC's, microscopes, incubators, centrifuges, pH meters, and other manufacturing equipment
Able to perform aseptic technique in a biological safety cabinet, media changes, cell passaging and in-process testing
Completes required documentation following proper GMP recording of entries and comments in batch records, forms and protocols
Initiate Document Change Requests; author, revise and review manufacturing documentation
Clean and maintain equipment for use in CGMP operations including the handling of CO2 and Liquid Nitrogen tanks and systems
Works within the team and department in order to follow best practices and meet department goals
Reports any issues related to manufacturing performance, process and safety to management in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement
BA/BS degree in Life Sciences or Engineering required, with 7+ years' relevant experience; or 5+ years with Masters' degree; or 2+ years' experience with a Ph.D. in. In lieu of a Life Sciences degree, candidates with a minimum of 10+ years of relevant industry experience in biotechnological and/or pharmaceutical manufacturing and quality assurance and/or quality engineering
Production/Processing - Knowledge of raw materials, production processes, quality control, and other techniques for maximizing the effective manufacture of pharmaceutical products. Includes advanced knowledge of aseptic technique and basic lab instruments, (Centrifuge, Pumps, Scales, etc.)
Biology - Knowledge of organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment
Safety/Security - Knowledge of relevant equipment, policies and procedures to promote effective and safe operations for the protection of people, data and company property
LI-EP

Senior Manufacturing Associate Resume Examples & Samples

Implement continuous improvements in ABC Production, using CI methodologies such as Lean
Evaluate business processes using standard tools to identify opportunities for improvement
Implement improvements to business processes to enable increased effectiveness and efficiency
Develop partnerships with other groups to enable effective collaboration
Bachelor’s Degree in science or engineering or equivalent
At least 8 years relevant experience; at least 10 years experience (preferred)
Training and certification in continuous improvement, e.g., Lean or Six Sigma, or substantial experience using CI methodologies to drive improvement
Strong computer skills, especially in standard office programs, preferably including data analysis

Manufacturing Associate Resume Examples & Samples

Assembles parts and/or products according to standardized work
Rotates through the department work stations based on business need
Maintains a clean, safe working environment according to 5s and department safety guidelines
Maintains flexibility to meet team, department, and plant goals
Participates in HMPS improvement activities within current department or other departments as appropriate
Commits to meeting overtime requirements
Performs additional responsibilities as requested to achieve business objectives

Manufacturing Associate Resume Examples & Samples

Plant cleaning (including floors, benches, fermentors, equipment, etc.) waste disposal, lean manufacturing and good manufacturing practices (GMP)/compliance
Record and document procedures with detail and accuracy. This includes batch records, training records, logbooks, standard operating procedures (SOPs) and validation protocols
Weigh and prepare culture media, buffers, and solutions
Set-up, prepare, and operate manufacturing equipment/labware/assemblies (including: filtration skid, chromatography skid, fermentor, autoclave/sterilizer, etc.) in accordance with current good manufacturing practices (cGMP)
Monitor fermentation and purification operations (including trouble-shooting and diagnosis of instruments, equipment, process, etc.)
Sample solutions and perform analytical assays (including cell counts, pH, conductivity, etc.)
Perform technical training (including hands-on and class based training)
Identify and implement equipment and process improvements
Coordinate and collaborate with vendors
Create and revise standard operating procedures, batch records, specifications, etc
Execute quality systems (includes: critical work orders (CWO), planned change requests (PCR), engineering change requests (ECR), deviations, corrective action preventative action (CAPA))
Coordination and collaboration of activities with other departments
Execution of other tasks/assignments/projects as given by Manufacturing Management
At least 2 years of college science in Cell Biology, Biochemistry, Chemistry, Biology, or a related field from a four-year college or university
Mfg Assoc II: 2 to 4 years of related experience; or 4 to 8 years of experience and/or training or equivalent combination of education and experience
Mfg Assoc III: 4 to 6 years of related experience; or 6 to 10 years of experience and/or training or equivalent combination of education and experience
Skills in Biological/Chemical Sciences, Math and English
Knowledge of cGMP’s
No physical limitations for lifting, standing, repetitive motions, color blindness or hearing impaired
Ability to lift >50lbs, stand on feet for 2 hours, squat, crawl, bend and work in loud, wet, and hot/cold environments

Manufacturing Associate Resume Examples & Samples

Reliably executes well defined SOP’s
Initiates revisions to current GMP/SOP guidelines
Operates TFF system, Rotavap, chiller, Microfluidizer, Homogenizer, rotary lobe pump, high shear mixer, SIP, autoclave, depyrogenation oven and CIP system
Maintains and qualifies aseptic bulk production operations in GMP production facilities containing over 27,000 square ft. of Grade A, B, C, and D clean room manufacturing areas

Manufacturing Associate nd Shift M-F Resume Examples & Samples

Quality Control of reagents and routine data analysis
Inventory Control of reagents, chemicals and supplies using proper labeling and computerized transactions
Labeling of tubes and bottles and dispensing of reagents

Manufacturing Associate Resume Examples & Samples

Operate bioprocess equipment under strict adherence to cGMP, OSHA and United Therapeutics policies and regulations
Write area SOPs and production batch records
Collaborate with process development on technical transfer issues
Work on problems of advanced scope with in-depth analysis of situations or data
Lead resolution of production problems
Ability to work shifts to cover a 24/7 operation
Demonstrated ability to work effectively in a team

Manufacturing Associate Resume Examples & Samples

Performs the manufacturing process for the GMP production of Master and Working Cell Banks
Performs Cell Bank verification runs
Performs support functions (e.g. Runner function) in the manufacture of Cell & Gene Therapies and final fill
Contributes to the overall operations and to the achievement of departmental goals and objectives
Performs basic Standard Operating Procedures (SOP’s) revisions and Solution Preparation Records as needed to accurately reflect manufacturing processes
Provides operational support for manufacturing activities including media/buffer preparation, cleaning activities, and equipment/materials staging
Supports technical transfer of production technologies from client to clinical and commercial operations
Edits Batch Production Records and Standard Operating Procedures as needed to accurately reflect process steps and capture process changes
Works on routine manufacturing assignments per written procedures, where ability to recognize deviation from accepted practice is required
May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts. Examples include Standard Operating Procedure (SOP) or Batch Record revision or generalized trouble shooting of equipment
Normally receives minimal instructions on routine work and detailed instructions on new assignments
Works under close supervision from supervisor or senior manufacturing personnel
≥ 2 Years in Cell Culture Technology with Associates degree or 0 - 2 Years in Cell Culture Technology with Bachelor’s degree with major in Biology, Chemistry or related Science major

Manufacturing Associate Resume Examples & Samples

May author/ review/improve SOP’s, batch records, protocols and technical reports
Actively participates in training activities, managing their individual training plan. Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area
Basic knowledge of current Good Manufacturing Practices (cGMP’s). Working knowledge of all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups
Familiar with or experience with cGMP Biotech or Pharmaceutical operations
Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management
Possesses a basic understanding of the scientific theory of biologics manufacturing
Possesses basic equipment understanding, including understanding equipment function and application

Manufacturing Associate Resume Examples & Samples

Cell culturing of hybridoma cell lines
Cell banking
Performing ELISA and PCR assays
Documentation in lab notebooks, controlled forms and data bases
Written and verbal communication

Manufacturing Associate, Level Resume Examples & Samples

Basic principles of hygienic practices and microbiology preferred
Familiarity with use of computers
Experience with processing in a cleanroom environment
Ability to follow and comply with detailed procedures
Experience of biological manufacturing operations preferred
Ability to work inter and intra-departmentally and potentially with customers. Ability to work in a team environment. Ability to strive in stressful situations

Manufacturing Associate Resume Examples & Samples

Working closely with the product develop team on new product transfers
Monitoring inventory and planning for new lot production in a timely manner
Conducting in process testing, optimization and troubleshooting by running multiplex bead-based assays and analyzing dataFollowing SOPs in manufacturing processes and documenting all manufacturing activities in an ISO-compliant manner
Filling customer orders

Manufacturing Associate Resume Examples & Samples

Responsible for production runs of manufactured components and the measurement of the product must conform to customer specifications
Load and unload parts
Perform inspection of parts
Operate machines per production and quality control requirements
Maintain the work area and equipment in a clean orderly condition
Complete required Quality/Production paperwork

Manufacturing Associate Resume Examples & Samples

Manufacture Virus Vectors under GMP regulations
Work with reagents, raw materials, and column packing for the for manufacture of clinical and non-clinical vectors
Perform upstream virus production and downstream purification

Manufacturing Associate Resume Examples & Samples

4) Participate in the creation and revision of manufacturing related documents
5) Participate in training and mentoring other operators on the floor
6) Participate on Continuous Improvement teams and implement continuous improvement tools in the area, such as 6S visual management and standard work
8) Perform disposal of hazardous waste
9) May perform other duties as assigned
10) Follow basic safety rules, SOPs, cGMP, work rules and other company’s policies
11) Perform removal of hazardous waste
Must be able to apply quantitative analysis to analyze process performance
Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement
Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Good procedural writing skills
Good computer skills, knowledge of Microsoft Word and Excel
Must have demonstrated interpersonal and leadership skills and be able to lead a work team effectively and efficiently in a team environment

Manufacturing Associate Resume Examples & Samples

Core manufacturing responsibilities - Works as a part of the team and fills, seals, inspects and labels antigen prodcuts in a GMP/ISO environment and prepares materials for filling operation according to standard operating procedures (SOPs). Performs other daily assigned tasks to support manufacturing and informs management of issues in a timely manner
Production Planning/Execution – Works with the Technical Services and Purification groups to support bulk fill operation
Equipment – Responsible for the operation of fill equipment, as well as preparation equipment such as autoclaves
Inventory Control – Performs SAP duties that include cycle counting, reservations, issuing to process orders, and charging of expiring raw materials
Lnspection and Labeling – Performs final inspection and labeling processing which may include qualification as a visual inspector
Compliance – Provides input and participates in deviation report investigations
Assembles, completes, and reviews run-specific batch record packets
Completes all training documentation within a pre-defined timeframe
Abides by the Quality Policy while contributing to organizational goals and metrics for Grifols Diagnostic Solutions
Works well in a team environment and utilizes project management skills to oversee completion of production lots
Complies with cGMP and ISO requirements
Maintains accurate documentation related to manufacturing processes
Demonstrates leadership skills to train and guide fellow associates
Minimum 2 years of experience with a BA/BS in a GMP environment (minimum 4 years of experience for Associate III)
Must have knowledge of fill/finish processes
Experience following and writing SOPs
Computer knowledge required with experience using MS Word and Excel
Able to document work accurately and has excellent organizational skills
Experience with preparation of reagents following manufacturing SOPs is desireable
Delivers quality products and services on time to all customers, both internal and external
Must be attentive to detail
Effectively manages time
Considers how daily activities impact product quality and the success of the business
Monitor processes and products to identify opportunities for continuous improvement
Experience in project management is desireable
Knowledge of Kaizen continuous improvement and 5S workplace organization is desireable
Qualification on clean room gowning and experience on operations performed in a clean room environment is desireable
Passing eye vision test to support 100% Visual Inspection activities is desirable

Manufacturing Associate Resume Examples & Samples

Basic understanding/familiarity with large scale manufacturing equipment
Proficient with computer systems
Ability to maintain and performance maintenance on basic machinery and tools
Efficient, error-free packaging operations
Education: High school level

Manufacturing Associate Coordinator Resume Examples & Samples

Participate in Safety Committee Meetings, and/or other plant-wide safety initiatives
Demonstrate effective communication (both written and verbal), as well as high levels of motivation and leadership
Support Lean Six Sigma activities, including generation of Kaizens
Maintain a professional approach and appearance for work activities
Excellent verbal and communication skills
Willingness to assist others in the department
2 years' experience in Production Coordinator or similar roles
Ability to manage several different tasks at the same time
Proficiency in working with the following computer programs/systems: Excel, Microsoft Word, PowerPoint, Microsoft Outlook, TMS, Dimples, and SAP

Manufacturing Associate Resume Examples & Samples

Demonstrated understanding of advanced operations line management techniques and theories
Intermediate understanding of semiconductor production operations concepts
Demonstrated time management and prioritization skills
Proven ability to communicate and present effectively to a wide variety of audiences
Proven ability in multi-tasking and driving complex projects
Basic understanding of algebraic concepts
Advanced PC skills and familiarity with MS Office Outlook, Word, Excel, and PowerPoint
Basic understanding of SPC principles
Proven ability to troubleshoot intermediate problems and identify and resolve root causes
Proven ability to lead teams to execute at high levels
Proven ability to recognize performance gaps and identify steps to improve
Proven ability to follow basic procedures and work with minimal supervision
Prepare an interview presentation that demonstrates their readiness for the role

Lynn Manufacturing Associate Resume Examples & Samples

Set-up and operate Mills and / or Lathes, Punch Press, Spot Weld, Bench and EDM Machines
Work with types of materials involved such as castings, forgings
Set-up involve changing chuck jaws, tool holders, fixtures, boring bars, drills, reamers, and setting tools
Work to established Lean Manufacturing guidelines involving one-piece flow, standard work, 6S, set-up reduction and wet process lines
Minimum of 1 year of machining experience with Lathes and / or Mills, Punch Press, Bench or Spot Weld Machines and EDM Machines
Demonstrated experience or successful completion of classes in geometric tolerancing
Demonstrated work experience in reading and interpreting blueprints
Ability to verify and inspect own work using micrometers, plug gages, height gage and surface plates
Ability to run manual equipment concurrently as required
Ability to work effectively in a cellular, team oriented environment
Ability to work under general direction with minimal supervision
Excellent attendance history
Ability to produce error free products
Accurately completes job related paperwork
Strives to meet or exceed job requirements
Experience with machining high temp material (inconel, stainless, titanium, etc.)
Working knowledge of Lean Manufacturing and a teaming environment
Experience machining to aerospace standards and specifications
Ability to work from and follow written instruction precisely (MOS, routers, engineering drawings)
Ability to operate multiple machines
Optical Comparator experience

Manufacturing Associate Resume Examples & Samples

Containment of issues as they arise on shift
Assist supervisor as needed on shift
Accountability for results
Contribute to a culture of safety first in compliance with Environmental, Health, and Safety (EHS) through all manufacturing associates and production engineers. Understand and follow Job Hazard Analysis (JHA) packets
Train and explain process to others and ensure execution of processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply
Understanding of supplier/customer process streams and interdependencies
Must be able to read and follow detailed written instructions and have good verbal/written communication skills
Experience in a regulated production

Manufacturing Associate Days Resume Examples & Samples

Conducts training for less experienced personnel
High school diploma/GED with 3-5 years of experience in cGXP manufacturing environment, or Bachelor’s Degree with 1-3 years of experience
Bachelor’s degree with 2-4 years of experience in bulk biologics cGMP manufacturing
Effectively uses process automation systems to operate production processes (i.e. DeltaV)
Experience in reviewing and creating controlled documents

Manufacturing Associate Resume Examples & Samples

Runs Directed Light Laser and Coherent Laser
Under limited supervision, uses schematics, blue prints, MAPs
Assignments are moderately complex
Ability to cross train in several areas including but not limited to Elastomer Shop, Fab Shop, and Screen Shop
Previous machine operation experience
A minimum of 5 years production experience

100

GMP Cell Culture Manufacturing Associate CMC Resume Examples & Samples

Operates and maintains production equipment as it relates to cell culture – fermentation. Including, but not limited to: calibrations, preventative maintenance, initiating work orders, etc
Performs a variety of complex tasks under general guidance and in accordance with current GMPs
Experienced with drafting, executing, documenting and reviewing data, and approval of SOP’s and batch records according to GMP guidelines
Maintain records to comply with regulatory requirements and performs daily in-process testing
Provides detailed observations, analyzes data, and interprets results
Initiates deviations, assesses product quality impact, and proposes and executes Corrective and Preventative Actions (CAPA)
Change owner for implementation or revision of equipment, documentation, and material specifications
Maintains daily workload schedule and relevant resource requirements
Proposes implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success
Develops effective working relationships with both internal and external partners
Provides training to new personnel in a specific technical process
Assisting in audits from internal or external partners
Transparent and adheres to quality standards set by regulations and GMP policies, procedures and mission
Communicates effectively with managers, colleagues and subordinates
Ability to participate effectively as a team player in all aspects of GMP’s
Demonstrated administrative leadership with knowledge-based expertise in related areas that can be applied to meeting GMP’s strategic goals
Travels as needed
Associates degree with a minimum of 5 years’ experience in upstream mammalian cell culture or upstream process development. GMP experience is a requirement
Knowledge of cell culture process steps including cell banking, thaw and expansion, production, and harvest
Experienced with manufacturing of bulk drug substance following SOPs and batch records within a cGMP regulated environment
Knowledge of specific product-related operations in cell culture/fermentation
Skill leading upstream production in absence of Associate Manager
Ability to ensure plans and resources (people, facilities, supplies etc.) are efficiently utilized to ensure uninterrupted supply of products produced
Ability to mentor and train colleagues
Occasional off shift work and weekend work
1st shift and/or possible swing shift, if necessary to meet manufacturing process schedule
On-call required for acknowledging alarms from equipment during off shift hours
Preferred BS degree in Chemical Engineering, Biotechnology, Biology, Chemistry or related Engineering discipline with 3-5 years mammalian cell culture experience, or MS with at least 2 years’ experience in upstream mammalian cell culture and cGMP manufacturing
Single use bioreactor and single use media preparation experience
Ability to observe technical issues and directs troubleshooting of process and equipment problems
Ability to operate with minimal supervision of complex systems and equipment and optimizes their use in manufacturing in accordance with GMP’s
Ability to work on complex assignments of diverse scope and ability to exercise judgment within defined procedures and practices to determine appropriate actions

101

Manufacturing Associate, Cell Culture Resume Examples & Samples

Completes required documentation following proper GMP recording of entries and comments in batch records, forms and protocols
Clean and maintain equipment for use in CGMP operations including the handling of CO2 and Liquid Nitrogen tanks and systems
Works within the team and department in order to follow best practices and meet department goals
Associate Degree with focus on Biologics and 2+ years of experience. In lieu of the Associates Degree, candidates with a minimum of 5 years of relevant industry experience in biotechnological and/or pharmaceutical manufacturing
LI-TW

102

Manufacturing Associate Resume Examples & Samples

Ability to interpret, receive direction and apply both written and oral communication
Flexible to quickly adapt to learning new tasks, moving to new areas to meet changing customer demands
Flexible and able to work overtime, nights, various shifts and weekends as required
Flexible to work in multiple areas as required
Demonstrated competencies in: teamwork, professional demeanor, quality, job knowledge, communication, problem solving and lean principles, flexibility, attendance and timeliness

103

Manufacturing Associate Resume Examples & Samples

Cross train and/or work on any Fiber/Web equipment as necessary including Leach to meet schedule
Work with hazardous chemicals
Understands environmental regulations as they pertain to operating the Industrial Waste Treatment area
Maintain accurate records, logs and collect any necessary date for use by
Use protective equipment as required
Other duties as required by management
Requires a high school diploma, G.E.D. or equivalent. Experience in a heavy manufacturing environment is desired
Able to read and understand written instructions
Must be accurate with both calipers and micrometer
Strong team attitude
Experience in like work centers
Ability to Able to lift a minimum of 60 lbs. on occasion
Ability to be accurate with both calipers and micrometer
Experience in working with steel microfibers is preferred but not needed
The physical demands and work environment characteristics that may be described here are representative of those an employee encounters while performing the duties/responsibilities of this job to include, but not limited to integrity, excellent customer service orientation, respect for others, leadership and communication skills. Reasonable accommodations may be made to enable individuals with disabilities to perform the duties and responsibilities
Any requirements may be modified to reasonably accommodate individuals with disabilities
Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees
Requirements are representative of minimum levels of knowledge, skills and/or abilities. The incumbent must have the abilities or aptitudes to perform each duty and responsibility proficiently
This description does not create an employment contract, implied or otherwise. All employment relationships at Pall Corporation - Deland are “at will.”

104

Senior Biopharmaceutical Manufacturing Associate Resume Examples & Samples

3-6 years prior manufacturing experience in the pharmaceutical or biotechnology industry, with the demonstration of a high level of performance
Strong verbal and written skills. Must be able to follow detailed processing instructions as well as accurately documenting all necessary documentation
Ability to work a shift that covers a 24/7 operation and work different/ rotating shifts
Monitor and audit work processes to ensure compliance and completion of goals
Assist with closure of process deviations, investigations and corrective actions
Maintains a high level of mechanical and technical aptitude and training
Assist resolution of technical and process problems; Identify, develop and implement process improvements
Works on problems of advanced scope where analysis of situation or data requires a review of identifiable factors, including process history
Identify process issues; collaborate with team and external departments to address best practices
Will work with some hazardous materials under the appropriate safety procedures
Small Scale Upstream Experience with knowledge of the following

105

Senior Biopharmaceutical Manufacturing Associate Resume Examples & Samples

Maintain at least 85% cGMP training to ensure compliance
Perform CIP , FIT and SIP of product tanks
Maintain at least an 95% cGMP training proficiency to ensure compliance
Able to work around heights, carry load up to 50lbs
Able to support 24/7 operations that includes weekends and holidays

106

Manufacturing Associate Resume Examples & Samples

Weighing and mixing epoxy-based materials
Light mechanical assembly of small components, using hand tools and torque drivers
Work with hands under a microscope performing hand soldering of fine pitch cables and flexible circuits
Manual assembly operations including shielding, gluing, and cable preparation
Use of high-precision tools such as: height gage, calipers, micrometers
Measurement of thin layers using high precision drop gauges
Ability to lift up to 25 pounds with or without accommodations
Experience in high tech manufacturing preferred
Must have excellent hand-eye coordination, manual dexterity
Must have the ability to read and comprehend written instructions
Must have excellent attention to detail
Volt has over 60 years of staffing experience. We work with many of the Fortune 500 and 1000 companies to provide workforce solutions. We offer many direct hire full-time positions as well as many contingent/temporary positions. We offer our workers competitive pay and benefits, as well as educational programs and redeployment assistance

107

GMP Manufacturing Associate Downstream Processing CMC Resume Examples & Samples

Assist in developing procedures (SOP’s & Master Batch Records) for the Manufacturing Downstream group
Complete assigned tasks associated with Purification operations and assist in execution of operations such as column chromatography, TFF, CIP, column packing
Assist in troubleshooting equipment or process issues
Initiate and complete deviations, change controls, investigations, as assigned using TrackWise or any similar software system
Ability to train other associates and willing to be involved in cross-training in other groups, as required
Ability to lead the purification operations
Ability to multi-task and work well with the team
Completes all training documentation within a defined time-frame
Performs review of the manufacturing documentation of the associated area
At minimum an Associate’s degree in biology, chemistry or a related scientific or technical area
2 to 4 years of experience within cGMP manufacturing. GMP experience a requirement
3-5 years hands on experience with Purification equipment such as columns, TFF, filling
Experience with TrackWise for performing change controls, deviations
Strong background in aseptic technique and microbial controls
Strong understanding of cGMP’s as applicable to biologic operations
Must be able to read, interpret, and follow SOP’s, batch documents and other procedures
5 or more years combined experience in cGMP manufacturing
S. in biology or related life-sciences field
Experience with process control SCADA software (e.g., WonderWare)
Experience with single use systems
Experience authoring controlled documents, such as SOP’s and batch documents

108

Manufacturing Associate Resume Examples & Samples

Working in a production environment
Ability work in team environment
Working on a production floor

109

Manufacturing Associate Resume Examples & Samples

Moving material in and out of warehouses
Lifting objects up to 50lbs
Handling finished materials and moving to appropriate storage areas within the warehouse
Working in a team environment to efficiently process orders
Ability to lift up to 50 pounds repeatedly
Ability to stand/walk for long periods of time

110

Manufacturing Associate Resume Examples & Samples

Ability to read assembly prints /Drawings
Basics math and computer skills
Ability to understand and adhere to policies and procedures
Ability and desire to work in a team orientated environment, quality conscious

111

Manufacturing Associate Resume Examples & Samples

Assemble furniture parts
Moving material in and out of machines
Lifting office furniture materials (up to 30 lbs)
Quality Control/Production Inspection
Verify/identify parts and/or materials; report shortages or damaged materials
Possess basic math skills, such as adding and subtracting
Ability to bend, twist, and stand for periods of up to 10 or 12 hours
Ability to work cooperatively within the team as well as with members of other teams to meet goals

112

Manufacturing Associate Resume Examples & Samples

May be cross-trained in other department operations
Medium physical demand requires continuous scooping, dumping, lifting or moving of 5 to 45 kg and frequent moving, pushing, pulling and rolling of up to 100 kg. Physical demand also involves standing/walking, reaching and grasping (75%) and stooping, crouching and sitting
Mental demand requires frequent attention to multiple, repetitive aspects of the tableting process as well as to the details of specific manufacturing instructions, verification of product integrity and recording of information on paperwork
Visual demand is continuous and requires good hand/eye coordination, clarity of vision at 20 inches or less and the ability to bring objects into sharp focus, to identify and distinguish colors, to handle small parts and visually inspect the product for quality standards
Exposure to active materials requires incumbent to wear a respirator/mask on a regular basis
Protective clothing including uniform shirt and slacks, jacket, safety glasses, booties, hairnet, hearing protection, gloves are worn continuously in performance of the job functions
Work hazards include proximity to moving mechanical equipment, exposure to active powder ingredients and dust, odors, cleaning agents, noise, and vibration
Perform the basic functions of arithmetic; add, subtract, multiply and divide all units of measure
Capability of operating tablet press
Accuracy and attention to detail are critical

113

Manufacturing Associate Resume Examples & Samples

Proficient in basic shop math including decimals and fractions and US standard measuring system
Has basic understanding and is able to use sound judgment to interpret production documents to meet production standards
Knows how to proficiently uses basic hand tools,
Must be able to correctly complete D.I.R.’s. and all required process documents,
Has the ability to effectively communicate, understand and follow verbal and written instructions
As required, knows how to use the computer terminal to access and enter production information and can efficiently use the information once accessed
Correctly uses basic measuring instruments such as micrometers, dial indicators and scale,
Knows how to interpret drawings, routings, sketches and work orders,
Understands diameters and radius,
Knows when and how to adjust setup during operations,
Has experience with ERP (SAP shop floor transactions) and barcode readers
Has experience in cellular manufacturing

114

Manufacturing Associate Resume Examples & Samples

Three (3) to four (4) years of previous experience in chemistry, molecular biology and/or biochemistry
Strong working knowledge of standard laboratory techniques of molecular biology is required (PCR, DNA and RNA isolation, bacterial transformations, microarray assays
Familiarity with TapeStation benchtop electrophoresis instrument

115

Manufacturing Associate Resume Examples & Samples

Complete required training (e.g. cGMP, safety and work instructions, etc.) within the stipulated time frame
Ensure compliance with all applicable company policies, procedures, safety and regulations at all times
Ensure proper housekeeping and maintain cleanliness (6S) of the working areas
Meet the schedules and performance expectations set up by Superiors
Familiar with our products, processes, work instructions, safety, and regulatory guidelines to the tasks associated
Able to take on additional tasks or responsibilities as assigned by Superiors/ Management
Able to efficiently maintain accurate training logs, training records, and assessment records, etc., able to provide guides to others to complete the tasks, and able to identify the opportunities for improvement
Able to efficiently maintain Department documents (e.g. organization chart, confirmations, Spot awards, Surveys, and other required documents) and training programs (e.g. training slides, training packages, evaluation forms, assessment documents, etc.), able to provide guides to others to complete the tasks, and able to identify the opportunities for improvement
Able to efficiently support the staff retention and new SA recruitment activities. (E.g. schedule & coordinate the interview, support the practical test & Fab tour, compile the interview results, etc.), able to provide guides to others to complete the tasks, and able to identify the opportunities for improvement
Able to efficiently maintain training matrix and certification for Consumables Manufacturing as well as provide guides to others to complete the tasks
Able to prepare and support (e.g. plan, schedule, communication, logistics, etc.) various events and training activities efficiently (e.g. training events, workshops, communications, meetings, demonstrations, team building, and external events, etc.), able to provide guides to others to complete the tasks, and able to conduct basic training/communications
Able to write simple training materials and other documents or certain part of documents (e.g. TTT program, SA interview program, new employee induction program, training evaluation forms, and job competency assessment documents, Dept. org chart, and other documents, etc.)
Able to develop and certify OJT trainers with minimal guidance
Able to conduct job competency assessment for shop floor employees with minimal guidance
Able to conduct periodic internal process audits (e.g. video audits), and/or 6S inspections, and document and compile the audit results & follow-up actions with minimal guidance
Able to monitor the completion of compliance training in LMS, Job competency qualification/certification, Incident acknowledgement, and the completion of new employee induction and probation, etc. with minimal guidance
Min. ‘O’ Level or equivalent required, with preference for NTC / NiTEC/ Diploma Certificate
5+ years of experience in a manufacturing/ production environment for ‘O’ levels or 0-2 years’ experience with NTC and above
1+ year of training experience at shop floor/ production line and with Train the Trainer are preferred
3+ years of experience as a team/line leader is a plus
Experience in GMP controlled manufacturing/ production environment is preferred
Basic Excel skills and Basic PowerPoint skills
Basic Presentation skills
Basic Coaching skills
Basic OJT assessment skills (e.g. good questioning, observation, and feedback skills)
Basic skills with minimal guidance on Supervisory and team management skills (e.g. feedback, motivation, promote team spirit, solve conflicts among subordinates and performance management, etc.)

116

Manufacturing Associate Conjugation Resume Examples & Samples

Have basic understanding of IgG antibody protein structure and how antibody conjugation is performed
Follow SOPs, forms and batch records
Perform basic math calculations to calculate amount of antibodies and concentrations
Ability to perform column chromatography, use spectrophotometer, UV detector and fraction collector
Familiar with ERP/MRP database to execute production order
Able to meet important deadlines and due dates related to antibody conjugation
Bachelor of Science in Biology, Biochemistry, Chemistry or related Science
1-3 years of relevant lab experience related to protein conjugation
Ability to follow SOP and batch records, prepare buffers, dilution, dialysis, centrifugation, column chromatography
Ability to use balance, Spectrophotometer, pipette, UV detector, agarose gel electrophoresis, pH meter
ERP/MRP database knowledge
Strong organization, documentation, and communication skills are essential
Must be able to take initiative, be flexible, and highly be motivated and dependable

117

Manufacturing Associate Resume Examples & Samples

Perform Filling, Lyophilization, Inspection, Label and Package Operations (including Engineering and Process Development runs) following standard operating procedures as needed on a small to large scale. Assist Validation to execute Validation protocols
Perform media, buffer and solution preparations with sterile filtration as needed. Perform daily and weekly cleaning of the manufacturing areas
Adhere with cGMP, CBER, USP, WHO, EP, JP, Sanofi Pasteur Global Quality Directives (GQDs) or other guidance. Responsible for completing cGMP documentation without documentation errors. Maintain the Manufacturing Area inspection ready. Maintain training at > 95%
Responsible for assisting in the scale-up, maintenance, trouble shooting of equipment issues and is able to effectively work with Facilities and/or EIT to ensure all equipment is in working order
Take an active role in creating and maintaining a safe environment. Follow all safety procedures. Attend all safety training and exercise self-disciplined to follow all HSE policies
Provide support to integrate best practices, where appropriate, into manufacturing
Requires immunizations prior to performing work within the manufacturing area
Must be able to read and follow detailed instructions and have good written and verbal communication skills
Good interpersonal skills and ability to work in a team environment

118

Production / Lite Manufacturing Associate Resume Examples & Samples

Executes timely re-supply of raw materials while operating production equipment
Ability to grip/grasp continuously during the assigned shift
6 months experience in a manufacturing environment required

119

Manufacturing Associate Resume Examples & Samples

1 – 3 years machining, warehousing, machine maintenance, welding, auto mechanic, career technical education (CTE) or related mechanical experience required
Must possess a clear understanding of general math including arithmetic, algebra, and geometry
Ability to read, write, speak & comprehend English
Ability to read and comprehend component drawings
Knowledge of basic computer skills, Microsoft Office
Demonstrated ability to use hand tools, power tools, measuring tools and material handling equipment
Successfully pass Work keys (score: 4) and Benet Manufacturing test
Successfully gain admission to State Center Community College Machinist and Maintenance Mechanic certificate programs
These positions are four-year, entry-level, developmental positions. These positions will include mandatory, paid-attendance in courses offered through State Center Community College District (SCCCD) at the Madera Center and Fresno City College CTE programs. Employees in these positions will be required to maintain a B average (3.0) or better as a condition of employment
Once employed, the employee will be expected to develop and advance into Manufacturing Associate levels 2, 3, and 4, in each subsequent year of employment
At the end of the four year program, employees will attain Journeyman status and SCCCD certificates, pending all requirements are met
Candidates will be selected for employment in either the Manufacturing or Service departments. However, all candidates will be cross-trained to work in both departments
Candidates, accepted into these positions, must be willing to travel throughout United States and internationally and must possess or be able to obtain a valid passport
Candidates, accepted into the positions, will be asked to commit to work an additional four (4) years after attaining Manufacturing Technician I or Service Technician I status with JBT, subject to performance reviews and quality of work. This provision does not alter or change JBT’s at will employer status

120

Manufacturing Associate PO Resume Examples & Samples

BS/BA or Associates Degree with 0-2 or more years of directly related experience. Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience
0-2 years prior manufacturing experience in the pharmaceutical or biotechnology industry, with the demonstration of a high level of performance
Understanding of the basic FDA cGMP regulations
At least six months of purification and chromatography experience
Completing daily manufacturing tasks per standard operating procedures and batch document instructions
Dispense large and small amounts of raw materials
Work with hazardous materials under the appropriate safety procedures
Must be able to follow detailed processing instructions as well as accurately documenting all necessary documentation

121

Lead Manufacturing Associate PO Resume Examples & Samples

5+years prior manufacturing experience in the pharmaceutical or biotechnology industry
Experience working in a large scale cGMP Purification Manufacturing
Ability to work a shift that covers a 24/7 operation
Strong problem-solving and troubleshooting skills as demonstrated by a consistent track record of solutions to technical problems within large scale cGMP Purification Manufacturing
Ability to perform the following operations: CIP, SIP, SOP, cGMP, Tangential Flow Filtration, UF/DF, Chromatography columns, Column packing, A280 Spectrophotometry, ,Virus filtration, Depth Filtration, Bulk Filtration, Aseptic technique, and, Filter integrity testing
Draft and revise SOPs and Batch Records as necessary
Lead closure of process deviations, investigations and corrective actions
Lead new production projects, develop commissioning plans and author commissioning documents
Member/Lead of project teams for technical transfer or new product scale-up

122

Manufacturing Associate Resume Examples & Samples

Picks, packs and prepares product for shipment as specified in the customer order and in accordance with division policies and procedures
Responsible for the complete and accurate shipping of all products, daily cycle counts, maintenance of finished goods warehouse and receipting of finished goods into the respective inventories in accordance with established procedures
Responsible for reporting accuracy of all shipping transactions in SAP
Reports any shipping related problems as they occur to the Logistics Manager
Supports goals of continuous improvement by serving on ad hoc committees and or teams as required
Contacts carriers for service
Minimum one year of manufacturing experience; preferably in a shipping/finished goods department
Shipping and forklift experience will distinguish the most desirable candidate

123

Manufacturing Associate Resume Examples & Samples

BS in a life science field with preference for chemistry or biochemistry
Two years experience in manufacturing or relevant industry. Will consider other work experience that demonstrates a strong work ethic and mechanical aptitude
Experience handling hazardous materials
Experience adhering to safety and following standard operating procedures
Experience using large scale chemical processing equipment or other industrial or manufacturing equipment
Ability to work independently with little supervision
Ability to organize work to keep several projects moving forward through effective time management and prioritization
Excellent communication skills, both verbal and technical
Consistently able to work quickly and accurately meeting department standards
Experience with the principles of lean manufacturing a plus
Experience utilizing inventory management systems, preferably SAP
Manufacture assigned products, following standard manufacturing procedures and quality standards
Will review existing manufacturing procedures and provide technical expertise to improve procedures
Complete equipment set-up, operation, post production clean-up and hazardous waste disposal
Complete in-process testing as required and update analytical staff on anticipated testing needs
Assist with resolving technical issues as well as maintenance of production equipment
May establish operation equipment specifications and improve manufacturing techniques
Assist in developing methods and procedures to control or modify manufacturing processes

124

Biopharm Manufacturing Associate Resume Examples & Samples

Ability to work shift that covers a 24/7 operation
Ability to lift and carry materials weighing as much as 50lbs
Monitors critical process parameters
Maintain and prepare high quality documentation

125

Manufacturing Associate Resume Examples & Samples

3+ years of experience in a manufacturing environment or 1+ year of proven work experience in Operations at the Lancaster, PA Plant required
1+ year of experience with computerized materials management and document tracking systems required
Experience working within chemical weigh, compression and/or processing preferred
Must be able to meet the physical demands of this job which include: Frequently lifting/carrying 1-10 lbs. and occasionally lift/carry 11-50 lbs., lifting from the ground to knees and waist and from the waist to shoulders
Excellent interpersonal skills required
Basic computer skills, including Windows Operating Systems and applications or equivalent required
Must be able to use manufacturing equipment, quality testing equipment and basic hand tools
The ability to work 2nd shift (2pm – 10pm) on a regular basis in support of continuous operations required along with the ability to have flexibility for overtime and/or working on the weekendsProduction

126

Manufacturing Associate Iv-various Shifts Resume Examples & Samples

Must be able to read and follow detailed written/electronic instructions and have good verbal/written communication skills
In depth understanding of manufacturing techniques and ability to prioritize in a fast paced environment
Troubleshoot and identify atypical processing conditions and how to respond to them
Understanding of supplier/customer process streams and interdependencies, and be able to work on cross functional teams
Must be able to read, write and converse in English
Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and US standards of measurement
Must have good interpersonal skills, be able to work effectively and efficiently in a team environment and provide constructive feedback and coaching to other Associates

127

Manufacturing Associate Resume Examples & Samples

Visually inspect part for details
Clean and wash part(s) with Solvent or other method as directed
Trim flash/excess materials and/or cut parts from various rubber parts and assemblies using cutting tools
Package parts per work instructions
Identify materials by tagging, marking and storing in proper location
Prepare inserts and/ or workstation with required tools and equipment
Operate light machinery (such as a beading machine)
Complete Hour-by-Hour chart
Train other employees
Follow written and verbal work instructions
Mechanical aptitude, occasionally may lift up to 30 pounds
Must be able to work up to 50 hours a week and occasional weekends
1+ years of experience required in manufacturing or heavy labor

128

We are Looking for a Manufacturing Associate to our Night Shift Team Resume Examples & Samples

Troubleshooting, mastering and experience in handling of deviations
Close cross-departmental collaboration with the other departments
As a person, you are proactive, responsible and well-organized
You are an experienced user of IT/control systems (knowledge of DeltaV is an advantage)
You are fluent in both written and spoken English and Danish

129

Manufacturing Associate Resume Examples & Samples

Perform precision CNC lathing operations
Perform limited programming of CNC lathes
Perform machine set up and diamond tool changes
Perform visual, optical, and dimensional inspection for verifications
Properly document manufacturing operations to comply with FDA regulations
Diamond tool inspection and monitoring
All other duties as assigned by management
Visual acuity correctable to 20/20 or better
Ability to add and subtract positive and negative decimal numbers
Ability to lift a maximum weight of 20 pounds
Ability to pay attention to details
Ability to effectively communicate with coworkers in a positive manner
Ability to sit and perform repetitive inspection procedures for extended periods of time

130

Manufacturing Associate Resume Examples & Samples

Perform visual, in-process and final inspection of parts
Package parts according to work instructions
Use equipment properly and follow safety features and operating procedures
Basic Math Skills

131

Senior Biopharmaceutical Manufacturing Associate Resume Examples & Samples

2-4 years prior manufacturing experience in the pharmaceutical or biotechnology industry
Assist in the training of less experienced team members
Prepares standard operating procedures and production batch records
Assist with technical issues and problems, identify deviations and collaboratively participate in the investigations

132

Lead Biopharmaceutical Manufacturing Associate Resume Examples & Samples

3-6 years prior manufacturing experience in the pharmaceutical or biotechnology industry
Operation of Bioprocess Equipment under strict adherence to and enforce cGMP, OSHA and polices and regulations, or others as required
Trains new and less experienced team members
Conduct relevant process, cGMP and safety training
Effectively troubleshoot equipment and processing problems
Ensures all production activities are completed in a safe and compliant manor
Leads the production team as required in the absence of senior staff
Lead resolution of technical and process problems, initiate change control for equipment/process modifications
Identify, develop and implement process improvements, equipment improvements/upgrades
Monitor and audit work processes to ensure compliance and completion of targets
In conjunction with Supervisor, insure completion of daily operations
LI-GSK

133

Biopharm Manufacturing Associate Resume Examples & Samples

Actively participates in effective troubleshooting of equipment and processing problems
Receive, stage and track materials
Assists with problems of moderate scope where analysis of situation or data requires a review of identifiable factors

134

Manufacturing Associate Resume Examples & Samples

Performs operations within defined labor standards
Sets up and operates production equipment
Accurately completes manufacturing batch records and equipment logs
Cleans and maintains work area and equipment
May perform equipment calibrations
Obtains training in Health and Safety, GMP or other areas as required
Computer skills (spreadsheets, office documents, etc..)
Industrial safety practices (OSHA)
Lab safety
Ability to understand and comply with a variety of policies of moderate complexity
Demonstrated ability to work independently as well as part of a team
Good hand and eye coordination and manual dexterity skills
Chemical solvent handling & safety
Ability to work in a clean-room environment with appropriate gowning restrictions

135

Manufacturing Associate Resume Examples & Samples

Assist Personnel in Handling of Material throughout the Fabrication area
This position will handle material on the paint line and serve as a helper in other areas
Must be able to lift up to 35 pounds on a consistent basis
Use Manual material handling equipment for moving loads in and out of the area
Ensure that all paperwork matches product and keep accurate counts
Occasionally will operate secondary equipment
Maintain neat and orderly work areas
Observe all safety rules and keep safety first for self and others

136

Manufacturing Associate Resume Examples & Samples

MPR generation and revision
On the floor support for execution of process changes
Training on documents and process changes
Document review and coordination of changes with production area
Support specialists/supervisors as needed
Supporting projects as needed
Reviewing source documents (QCTP, FFR, PD, etc) to ensure alignment with manufacturing capabilities
Recipe review and testing
Contributes to the development of new concepts, techniques, and standards
Considerable knowledge of cGMP standards, and the current code of Federal Regulations (CFR)
Considerable knowledge to perform trouble shooting and root cause analysis
Equipment knowledge to perform first line trouble shooting and root cause analysis
1-3 years work experience in pilot or commercial biologics manufacturing under cGMP with Bachelors. 0-2 years with Masters degree
Good organizational skills
Basic first-line management skills for daily operation
Situational Self Leadership

137

Lead Biopharmaceutical Manufacturing Associate Resume Examples & Samples

BS/BA or Associates Degree with 5+ years of directly related experience. Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience
5+ years prior manufacturing experience in the pharmaceutical or biotechnology industry, with the demonstration of a high level of performance
Demonstrated ability to work effectively in a team, lead teams and implement project plans on time and on budget
Ability to lift and carry materials weighing as much as 40lbs
Must demonstrate GSK values and behaviors at all times
Operation of Bioprocess Equipment under strict adherence to and enforce cGMP, local EH&S, OSHA and polices and regulations, or others as required
Completes daily manufacturing tasks with strict adherence and compliance to Batch Records, SOPs and good GMP practices and procedures
Monitors critical process parameters; Ensures any changes noticed in process parameters are communicated to the next level of supervision
Documents/Communicates all manufacturing activities clearly and accurately
Qualified and authorized to train on most/all processes within department; Conduct relevant process, cGMP and safety training
Provide information to the supervisor on performance of the team
Coach, facilitate, solve work problems and participate in the work of the team
Communicate assignments, milestones and deadlines to the team and individuals based on supervisor’s instructions
Actively leads continuous improvement processes and/or represents department cross-functionally
Leads the production team as required in the absence of supervisor. Ability to adapt to shifting priorities and schedule changes based on minimal supervisor instruction
Lead troubleshooting/resolution of technical and process problems, initiate change control for equipment/process modifications
Ability to process maintenance, calibration, and equipment repair work orders and informs supervisor in timely manner
Assists specialist/management in investigations for departmental deviations; Lead closure of process deviations, investigations and corrective actions as needed
Ability to represent department as a Subject Matter Expert (SME) during internal/external audits; Present the manufacturing areas in a state of audit readiness
Develops effective working relationships with team members and across functions
Actively represents and/or lead in cross-functional team activities such as BDS, Changeover, Process/Cleaning Validation, Technical Transfers, New Product introduction (NPI), etc

138

Manufacturing Associate Resume Examples & Samples

Coordinate and perform training of others with respect to the safe and responsible operation of assigned manufacturing equipment mentioned above
Adhere to, provide input to, and edit documented work instructions such as PPF, POCI, EOI, JSA, assembly prints, and others
Ensure electronic updates of inventory and work order transactions are timely and accurate
Relevant experience operating industrial or military mechanical equipment
Proficiency with computer programs (experience with spreadsheets and Material Management programs will be considered a plus)

139

Manufacturing Associate Resume Examples & Samples

Processes, cryopreserves, and otherwise manipulates cell products using sterile techniques
Process and test products: cell counts, viability, sterility sampling, and tissue culture
Proficiently operate equipment according to designed procedures.:cell washer & counters, temperature monitoring systems, laminar flow hoods, microscopes, centrifuges, pipettes, etc

140

Manufacturing Associate Process Development Resume Examples & Samples

Performs routine troubleshooting for purification/conjugations with minimal supervision
Demonstrates consistency in technique, documentation, data entry, labeling, sample collection, equipment operation, and production yield. Complete weekly assignments on time
Prepares summary reports when performing process/product troubleshooting and optimization
Performs column chromatography, use spectrophotometer, UV monitor and fraction collector
Follows SOPs and batch records instruction
Requires a BS degree in life sciences
2 years of experience in a research or biotech manufacturing environment
Ability to meet important deadlines and due dates, multi-task, and work independently within a team-oriented environment
Working knowledge of practical ability in a variety of complex laboratory procedures, established techniques, instruments, and equipment
Understanding of the theory of measurement
Experience developing or improving manufacturing processes for antibody production
Basic understanding of antibody chemistry and purification

141

Manufacturing Associate Resume Examples & Samples

Synthesize complex organic molecules and modified oligonucleotides per established protocols
Follow established processes and protocols for the synthesis of complicated organic molecules and modified oligonucleotides
HPLC purification and analysis of complex organic molecules and modified oligonucleotides
Operate in compliance with all appropriate regulatory and safety requirements
Work with cross-site and cross-functional teams in R&D, EH&S, Product Marketing, and Manufacturing Engineering

142

Manufacturing Associate Resume Examples & Samples

Clean, Set up, operate, and teardown of equipment in the department such as tanks, filtration systems, room sanitization, etc
Will be responsible for training on the manufacturing process
Manually clean portable equipment and small parts
Work with other departments to ensure adherance to production schedule
Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.)
Perform routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion
Prepare media and buffers solutions
Perform sampling using aseptic techniques
Receive and distribute supplies into production area as necessary
Execute Minor Document Change Control
Issue Documents
Generate Work Orders
Understanding of supplier/customer procss streams and interdependencies
Troubleshoot and identify atypical conditions and how to respond to them
May train others on complex processes and explain process to others
Understanding and compliance in Standard Operating Systems, Current Good Manufacturing Processes (cGMP) & Good Documentation (GDP)
Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems
Must be able to work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements
Must have a basic scientific understanding of microbiology, chemistry, sterility, and lyophilization as it applies to the manufacturing process
Must have working knowledge of basic aseptic practices
Must have knowledge of basic laboratory and pharmaceutical production equipment and operation
Ensure safety, security, and the environment in all aspect of the daily activities and any potential safety hazardous are addressed and corrected immediately
Must demonstrate the following shared values: Must have passion to innovate and drive for solutions, must display personal accountability for results and integrity, must have uncompromising dedication to quality, must have relentless focus on rapid and disciplined action, must have personal accountability
The position requires shift, weekend, and holiday work. Overtime may be required at times
Passion for Improving Lives. Must be able to put our patients at the center of everything we do
Inspired Teams environment. Must be able to thrive in diverse high performing teams

143

Manufacturing Associate, IG Purification Resume Examples & Samples

Drive schedule adherence on the Manufacturing floor
Involved in hands-on execution of manufacturing operations
Support a perfect equipment culture, by assisting maintenance team during implementation of programs such as Total Preventive Maintenance (TPM), equipment reliability, Preventive Maintenance (PM) and Predictive Maintenance (PdM) programs, etc
Support process technical transfer activity execution
Support the implementation of Kanban and 5S systems to assist from CQV to Full production environment
In depth process understanding of primary work areas and manufacturing techniques (e.g. Buffer preparation, fractionation, purification, fill, finish)
Basic Knowledge of Delta V, PLC based process control systems. Human Machine Interface (HMI) configuration
Must have customer services and leadership attitude to take ownership of any maintenance related problem

144

Manufacturing Associate Level Resume Examples & Samples

Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good documentation procedures (GDPs), troubleshooting issues and review documentation as appropriate
Demonstrate proficiency at laboratory tasks, such as monitoring pH, conductivity, product sampling etc. May train other associates on these tasks
Administrative tasks – attending shift exchange, meetings, sending/receiving emails, participating in projects
 High School Diploma or Equivalent minimum; AS/BS preferred
 Preferred area of study: Science related discipline
 5+ years’ experience in manufacturing; GMP setting preferred, and/or 24 months experience as an Associate Level II in bio-pharm industry
 Proven logic and decision making abilities, critical thinking skills
 Strong written and verbal communication skills are required
 The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities. Is open to and actively seeks out feedback on their performance and translates that feedback into action

145

Fixed Term Manufacturing Associate Resume Examples & Samples

Undertake all required training in a conscientious and enthusiastic manner
Adherence to and compliance with all cGMP and safety procedures at all times
Ensuring machines are in working order and calibrated
Operating of appropriate systems (e.g. SAP,LIMS, etc)
Cleaning of manufacturing equipment and rooms in compliance with housekeeping standards
Proficient in setup and operation of processes to deliver quality product each time every time
Front line troubleshooting integrated into process support mechanism
Operate plant in a manner that maximises reliability

146

Manufacturing Associate Resume Examples & Samples

Ability to objectively coach employees and supervisors through complex, difficult and emotional issues
Ability to research and analyze various types of data and information
Must have the ability to make recommendations to effectively resolve problems or issues, by using judgment that is consistent with standards, practices, policies, and regulations of government law
Technically savvy in Microsoft Office and other computer applications
Organizational skills and ability to manage multiple priorities, projects
Manage internal and external employment activities (recruiting, interviewing, selecting, hiring and promotions) for hourly and some salary staffing for Carolinas-based facilities
Provide guidance and expert advice to management or other groups on recruiting, selection and retention. Lead job modeling sessions for hiring managers
Manage relationships/contracts with search firms, staffing & government agencies, schools and other sources in recruiting qualified applicants
Provide employee relations support as needed
Provide compensation recommendations, including job grading, for salary and hourly employee, position changes
Provide reports and analyze employee wage and compensation data as needed

147

Manufacturing Associate Resume Examples & Samples

Must be able to handle small instruments
Must be able to use a computer and make accurate entries
Must be able to follow instructions
Must be able to read and write in English
Must be able to observe company policies and safety procedures at all times

148

Biotech Manufacturing Associate Resume Examples & Samples

Cell Culture, passaging of cells
Participate in the manufacture of recombinant proteins
Report and investigate deviations
Assist in the commissioning, qualification and requalification of equipment
Writing and reviewing documentation
A mechanical aptitude
An understanding of process flow, aseptic technique and fermenters
Some manufacturing experience is preferred
Meticulous nature and an aptitude to learn
Tertiary qualified

149

Manufacturing Associate Resume Examples & Samples

Formulate biochemical reagents ensuring they meet all specifications
Routine testing and calibration of lab equipment
Actively contribute to team discussion, project planning and project execution
Review batch records for accuracy and completeness
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities

150

Manufacturing Associate Technician Resume Examples & Samples

Adheres to and motivates others to follow the work instructions
Completes equipment calibration and setup; promptly communicates any maintenance issues to Supervisor
Proactively identifies quality, process, and workflow problems; informs Supervisor of any outstanding or re-occurring issues
Participates in the training of Associates; mentors new hires and cross-trains associates as necessary
Actively communicates and shares information and expectations with Supervisor; participates in team meetings and focus groups and offers input on facility issues
Demonstrates a positive attitude; treats all associates with respect and dignity. Reports any issues/concerns to Supervisor
Actively supports management decisions and communicates concerns when appropriate; assists the Team Leader and Supervisor in the execution of their duties
Maintains a clean, safe work area; notifies Supervisor of potential safety/health issues
Supports, follows and monitors all safety requirements and provides immediate feedback to all/anywhere necessary
Previous experience working in a fast paced environment
Ability to communicate clearly and concisely
Ability to prioritize, maintain organization and meet strict deadlines
Reliable in attendance and punctuality, including breaks and lunch periods

151

Manufacturing Associate Resume Examples & Samples

Perform all essential functions related to antibody purification manufacturing including centrifugation and making buffers
Follow SOPs, forms, and batch records
Perform column chromatography and use the spectrophotometer, UV detector, and fraction collector
Use ERP/MRP database to execute production orders
Maintenance of laboratory equipment and supplies
Adhere to lab operations protocol and antiseptic techniques
Bachelor’s Degree in Biology, Biochemistry, Chemistry, or related field
Minimum of 6 months of relevant lab experience related to protein and antibody production, purification, or conjugation or equivalent academic experience
Basic understanding of antibody structure, conjugation, and purification
Ability to meet important deadlines and due dates and the ability to multi-task
Must be able to work independently within a team-oriented environment
Skills required: Follow SOP and batch records, prepare buffers, dilution, dialysis, centrifugation, column chromatography, use of balance, Spectrophotometer, pipetting, UV detector, agarose gel electrophoresis, use of pH meter, ERP/MRP database knowledge or ability to understand similar computer systems
Ability to multi-task and meet multiple deadlines
Industry experience in protein and antibody production, purification, or conjugation

152

Manufacturing Associate Resume Examples & Samples

Be a consistent contributor, under the guidance of a shift leader
Demonstrate general knowledge of standard laboratory practices and equipment
Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data
Monitor process operations to ensure compliance with specifications
Complete tasks in support of large scale manufacturing, including in the care of high-value capital equipment, such as pilot-scale chromatography systems
Adhere to Pilot Plant gowning procedures and maintain a clean general operating area

153

Manufacturing Associate, nd Shift Resume Examples & Samples

Assist in the investigation of procedural deviations
Practice safe work habits and adhere to Moderna’s safety procedures and guidelines
Bachelors degree and 0-2 years of experience in a GMP manufacturing environment

154

Manufacturing Associate Resume Examples & Samples

Learns to set up and operate assigned production equipment in accordance with current good manufacturing
Practices and standard operating procedures
Blast and Debur
Material Handling
Preventative Maintenance
General Helper
Start up and shut down assigned processing equipment
Getting information – Observing, receiving and obtaining information from all relevant resources
Communication with supervisors and peers
Monitor processes, materials and surroundings to learn, detect or assess problems
Minimizing waste and duplicate work by carefully reading and understanding the task to be performed, utilizing only the materials necessary for the job, and expertly managing appropriate tools to execute the assignment
Minimize down time through seeking and developing additional shop skills, increasing job flexibility within the shop
Cooperate with the HS&E Department, the investigations of accidents or incidents that you may become involved, directly or indirectly
Implement preventive and/or corrective actions as directed by the mentor, supervisor or HS&E department
Inform your supervisor, other JBT employees and the HS&E Department of any unsafe act or condition
Participate actively in HS&E safety meetings
Follow JBT Commitment to Ethics Guidelines, policies and regulations
Always use properly the EPI adequate to the area and job assigned
1 – 3 years related experience
Successfully pass Work keys (score a 4) and Benet Manufacturing test (score a 4)

155

Manufacturing Associate, Temp-hire Resume Examples & Samples

0-1 years related experience in similar function or industry, or equivalent combination of education and experience
Basic communication skills
Packaging and Quality Inspection

156

Manufacturing Associate Resume Examples & Samples

Inspect, cut and lay-up of dynalloy, fibermet and continuous rolls
Operate calendaring equipment (rolling mills)
Cut and calendar wire mesh
Material handling and identification
Staging and unstaging media sheets, continuous rolls, mesh and elements
Building and loading fixtures
Calendar media sheets and continuous rolls to manufacturer and thickness specifications
Passivation of media sheets
Operate continuous Hydrogen furnace and Vacuum furnaces
Final inspection, trim and package of media products
Prepare and maintain records as required
Ability to read and understand complex instructions and work from schedules
Accurately use measuring devices as required
Use personal protective equipment as required
Good mechanical skills and troubleshooting ability
Maintain an acceptable level of all Company Policies
Assist other team members as instructed by your Team Leader or Supervisor
Able to lift a minimum of 60 lbs. on occasion

157

Manufacturing Associate Resume Examples & Samples

Performs Elastomer Inspection, Testing and Shipping
Performs Elastomer Milling and Color matching
Runs Elastomer Press and performs Die Cutting
Develops Manufacturing Assembly Procedures
Enters DPU data and runs DPU reports
Under limited supervision, uses schematics or assembly drawings, verbal and written instructions to assemble, modify, rework or inspect units

158

Manufacturing Associate Resume Examples & Samples

On the floor support for execution and process changes
Support Specialists/supervisors as needed
Reviewing source documents (QCTP, FFR, PD, etc.) to ensure alignment with manufacturing capabilities
Considerable knowledge of cGMP standards and the current code of Federal Regulations (CFR)
Considerable knowledge to perform troubleshooting and root cause analysis
B.S./B.A./M.S. in engineering, biological sciences, physical sciences, or equivalent field of study
3-5 years work experience in pilot or commercial biologics manufacturing under cGMP with Bachelors preferred. 2-4 years with Master’s degree preferred

159

Manufacturing Associate Manager Resume Examples & Samples

Demonstrated abilities with respect to manufacturing and testing of RF microelectronics. Experience managing represented and/or hourly employees in manufacturing
Understand manufacturing processes within a microelectronics environment
Embrace leadership and behaviors in day to day activities and execute tactically to achieve the organization’s strategic goals
Experience with selection, training, performance assessment, work assignments, salary, recognition of employees, and/or disciplinary actions
Proficient with Microsoft Office Suite software (Project Schedule, Excel, PowerPoint, Word)
Basic knowledge of the Skill Certifications Training database and Property Coordinator functions
Familiar with manufacturing automation including pick and place and wire bonding
Using/Understanding PODs (Production Operation Directives)
Basic knowledge of SAP, Capacity Planning and Dispatch reporting that drive business rhythm. Green or Black belt certified

160

Manufacturing Associate Resume Examples & Samples

Perform all essential functions related to antibody purification, including clarification, dilution, and dialysis of antibodies
Perform basic math calculations to calculate concentrations and amounts of antibodies
Follow Standard Operating Procedures and batch records for antibodies and buffers
Use basic lab equipment: micropipettes, spectrophotometers, centrifuges, pH meters, and balances
Perform affinity and size exclusion column chromatography
Perform SDS-PAGE and IEF Gel electrophoresis
Enter information into ERP database and other databases
Perform Endotoxin test
Maintain laboratory equipment and supplies
BS degree in Biology, Biochemistry, Chemistry, or Science
1-5 years relevant lab experience with antibody purification using column chromatography and use of a spectrophotometer
Strong organizational, documentation, and communication skills are essential
Must take initiative and be flexible, highly motivated, and dependable
Must be extremely detail-oriented
Experience with automated purification systems also a plus
Good computer skills are a plus

161

Manufacturing Associate Resume Examples & Samples

Must be a US Citizen or Permanent Resident Alien
Previous manufacturing operations experience
Ability to make computations involving decimals and fractions
Ability to set up machines, troubleshoot, do standard walk-arounds and inspect own work

162

Manufacturing Associate Resume Examples & Samples

Tissue culture using aseptic technique
Maintenance and feeding of cells in bioreactors
Thawing, culturing, and freezing cells
Cell counting
Clarification of tissue culture supernatant
Preparation of media
Preparation of autoclaved supplies related to production
Assisting on other areas including ELISA, cell thawing, data entry, etc
Maintenance of bioreactors and associated equipment
Development of experiments for process improvement and optimization
BS in Biology or related field
Excellent aseptic technique
Proficiency with Microsoft Office, including Excel
Some holiday and weekend work will be required
Maintenance of regularly used equipment
Tissue culture experience
Bioreactor experience
GMP/GLP experience
Additional experience handling different cell lines and bioreactors

163

Biopharmaceutical Manufacturing Associate Resume Examples & Samples

Ensures all processing equipment and materials necessary are adequate and available to set the team up for success
Maintains at least 85% cGMP training to ensure compliance
Dispense large and small amounts of raw material
Perform CIP and SIP of product tanks

164

Manufacturing Associate Resume Examples & Samples

Chemistry or biochemistry college coursework
Prior experience in the operation of various types of filling and packaging equipment in a production environment
May assist with resolving technical issues as well as maintenance of production equipment
Assists in developing methods and procedures to control or modify manufacturing processes
Fill various types of bottles with different products using manual filling equipment. This includes both liquid and powder filling. Responsible for the timely and accurate completion of dispensing jobs as demand necessitates
Assist R&D and PD in the dispensing of new products for validation prior to new product launch
Precisely follow Manufacturing procedures, safety guidelines and quality system procedures. Must be extremely detail oriented, efficient and accurate in all work related to dispense and related activities
Responsible for setting up and maintaining equipment and dispensing hood as needed. Assure proper operation, calibration, and cleanliness prior to dispense
Monitor inventory of supplies. Plan equipment and order reagents and materials as necessary
Assure that all bulk products, reagents, solvents and vials are in stock and prepared as indicated in the dispensing protocol
Complete all documentation for dispensing including opening/closing jobs, Manufacturing procedures, forms, and related paperwork as needed
Responsible for the submission of samples, vials, and solutions for specified testing to the Analytical Services Department. Consult with ASL as required
Required to maintain extreme accuracy and attention to detail at all steps, assuring the correct use of indicated materials, reagents, finished goods
Train others in basic dispensing tasks
Assist in analyzing, designing, developing, testing, documenting, and implementing new and existing processes for the Dispensing area
Make recommendations for changes or improvements to protocols, procedures, SOPs, shop order notes, and any other documentation needed for dispense jobs
Adhere to company policies to ensure protection of the environment
All employees must complete assigned duties in a safe manner, thoroughly familiarizing themselves with safety concerns, such as reading safety data sheets, wearing necessary protective clothing, including safety glasses, chemical resistant gloves, respirators, etc. All employees are required to attend regularly scheduled safety meetings. Responsible for monitoring safety practices of assigned area
Understand and comply with all elements of the Promega Biosciences quality system appropriate for this position

165

Manufacturing Associate Resume Examples & Samples

BS degree in a scientific discipline or equivalent work experience
1 to 3 years’ experience preferred operating in a biologics manufacturing facility environment subject to U.S. and international regulations
Cell culture experience is essential, preferably with disposable reactors. Microbial fermentation and associated recovery process experience a plus (i.e. fermentation, homogenization, harvest and recovery via continuous centrifuge)
Hands-on experience with disposable/single-use technology is desired (i.e. solution mixing and storage systems). Experience with multiple disposable/single-use systems a plus (e.g. Sartorius Stedim, Xcellerex, Millipore, ASI, etc)
Experience in equipment qualification is desired (i.e. set-up and execution of installation/operational/performance protocols (IQ/OQ/PQ)

166

Shift Manufacturing Associate Resume Examples & Samples

Responsible for performing varied and general tasks involved in manufacturing process. These tasks include, but are not limited to; basic manufacture, assembly, operation of basic hand tools and operation of assigned production/manufacturing
Must be able to work in a bench-top assembly environment using a variety of manufacturing equipment while prepping, stripping, tinning, crimping and soldering of medical cables
Responsible for labeling the cables, packaging and in-process testing
Must be able to work in a lean 5S environment
Accurately record process documentation
Must be able to interpret, read and follow all work instructions and engineering drawings
Must comply with all safety requirements including; manufacturing practices and procedures, standard operating procedures and manufacturing documentation
Basic measurement skills using a variety of hand tools and electronic equipment such as rulers, scales, micrometers, calipers and similar items
Must pose aptitude to do electronic assembly. Perform a variety of duties, routine and repetitive
Must be able to work in a fast paced work environment while performing manufacturing duties
Excellent hand and eye coordination is a must
Excellent attendance and a positive attitude is a must
Good written and oral communication skills; must have the ability to communicate effectively and project a professional image when giving and taking information in writing and in person
MUST be able to read and review ALL Work Instructions and interpret instructions for Manufacturing
Ability to follow verbal and written instructions
Good analytical skills including the ability to identify potential problems. Capable of both communicating and understanding the English language

167

Bio-processing Manufacturing Associate Resume Examples & Samples

Performing patient process unit operations and support operations described in standard operating procedures and batch records
Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records
Performing tasks in a manner consistent with the safety policies, quality systems, and GMP requirements
Completing training assignments to ensure the necessary technical skills and knowledge
Assisting in setting up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities
Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
Working with production planning, Sr. Manufacturing Manager, and lead associates to establish daily unit operations schedule that includes people, product, and material flow across multiple shifts
0-2 years of experience in cGMP biologics cell culture manufacturing, experience in cell therapy manufacturing preferred
Experience in the following preferred

168

Lead Manufacturing Associate Resume Examples & Samples

BS/BA or Associates Degree, Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience
Large Scale Purification experience preferred
At least 3 years of experience leading the purification process
Documenting all manufacturing activities clearly and accurately
Actively participates in the creation and revision of Batch Records, Standard Operating Procedures and other GMP documents
During technical transfer and the start up activities, provide input on design and operation of equipment
Work on problems of advanced scope where analysis of situation or data requires a review of identifiable and unknown factors
Maintain at least a 95% cGMP training proficiency to ensure compliance

169

Manufacturing Associate Resume Examples & Samples

Previous Assembly experience
Experience and the ability to start, run, and make adjustments to machinery
Experience and the ability to perform a visual quality check
The ability to read and understand work instructions
The ability to read and understand measurements
The ability to communicate effectively with Team members and Supervisors
Reliable Transportation a must
Must be able to pass all pre-employment screening

170

Manufacturing Associate Resume Examples & Samples

Actively involved in the manufacturing of oligonucleotide APIs in a GMP environment
Actively involved in aspects of technology transfer and scale-up of oligonucleotide manufacturing processes delivered from Manufacturing Technical Services into Manufacturing
Occasionally writing standard operating procedures according to regulatory and procedural guidelines
Working with Manufacturing Management and Quality to resolve manufacturing problems including drafting quality documentation (CAPA, deviation, change control, etc.)
Maintaining, calibrating, and trouble shooting critical process equipment
BS in chemistry, biology, biochemistry, science preferred; equivalent combination of education and or experience may be considered
2+ years of related experience in a pharmaceutical manufacturing environment preferred
Previous knowledge of oligonucleotide synthesis, HPLC, UF, conjugation, and lyophilization is advantageous
Detail oriented and can perform technical duties following standard operating procedures and general laboratory safety rules
Ability to work both independently and in a team setting on a variety of projects and use individual discretion to meet required project objectives and deadlines
Mechanically inclined
Ability to work as a successful member of a team working to establish priorities, scheduling, and procedures that collectively will meet department goals and project deadlines
Previous experience in a FDA regulated manufacturing environment highly desired

171

Manufacturing Associate Biomarker & Immunoassay Resume Examples & Samples

Manufacture kit components, including preparation, bottling, labeling, and storage according to standard operating protocols
Perform in-process testing to ensure the quality of components and kits
Document, analyze, and review data
Package kits and transfer with proper documentation
Manage inventory and plan and schedule production
Work closely with Product Development group to ensure proper transfer of new product from Product Development to Manufacturing
Fulfill custom orders
Perform additional tasks assigned by supervisors
BS in a biology, chemistry, or other related field
1 year of hands-on experience in a laboratory setting
Must have good mathematical skills and be comfortable with calculations
Must be a quick learner
Hands-on experience with immunoassays or other functional assays
Working experience in a manufacturing setting in compliance with ISO9001/ISO14835 standards

172

Manufacturing Associate Resume Examples & Samples

Operation of DNA sequencers or similar instrumentation experience is highly desirable
Good troubleshooting skills required
Proficiency with Microsoft Office Tools (Excel, Word, and PowerPoint)
Strong organizational skills, attention to detail and accuracy, and the ability to work independently in a team environment are essential

173

Manufacturing Associate Resume Examples & Samples

Finalizes all required paperwork thoroughly and timely (i.e. Production Reports, Rack Tickets, Labels, Component Sheets, Rework Sheets, SAP Transactions etc.). Maintains accurate attribute/variable charts of rejected materials. Conducts variable charts on manufacturing processes and count of good product as required
Completes miscellaneous tasks as assigned in support of the larger organization and production goals
Maintains a clean and safe work area. Wears required Personal Protective Equipment. Performs duties in a safe manner and observes approved safety procedures. Communicates potential hazards immediately to supervisor

174

General Manufacturing Associate Resume Examples & Samples

Pass employment screening
Ability to perform physical requirements per ADA
Ability to understand and follow instructions
Ability to perform Core operations within the BU
Understand Lean Fundamentals
Ability to work within manufacturing and quality documentation systems
Ability to read and understand procedures and blue prints
Ability to manufacture safe and effective product

175

Manufacturing Associate Resume Examples & Samples

Performs routine procedures following written instructions (SOPs, batch records, protocols, etc.) in support of manufacturing cell therapy product of acceptable quality in compliance with FDA and state regulatory requirements including but not limited to human tissue processing, cell expansion, cell feeding, counting, cryopreservation, harvesting and product seeding
Performs and documents all operations according to good aseptic techniques, current Good Manufacturing, Good Tissue and Good Documentation Practices
Maintains, prepares, cleans, and disinfects manufacturing areas and manual, semi-automated and automated equipment. Maintains required record keeping of equipment cleaning, disinfection and use
Prepares sterile solutions, process reagents, and media in support of aseptic manufacturing processes
Reports Manufacturing and Quality Control discrepancies and deviations as necessary and participates in Corrective and Preventive Action investigations
Inputs data into computerized databases and records process step performance in written batch records and concurrently with operations
Assists in validating and calibrating equipment used for processing
Assists in collecting data for QA, QC, and Development reports
Maintains compliance with GMP reporting requirements and regulatory policies
Performs tasks assigned by the Supervisor or Manager such as maintaining equipment lists, ordering supplies and/or equipment, ordering documents from Document Control, etc
Ability to be gown certified for cleanroom work as needed within 3 months of hire and semi-annually thereafter
May interact with auditors and federal and state health authorities during inspections
This position has a direct impact on product and patient safety
This position may be exposed to potentially contaminated tissue, blood or other bodily fluids. In compliance with Occupational Safety and Health Administration (OSHA) regulations, Aesculap will provide required training and a safe working environment for all employees
Must embody the Company’s Vision, Mission and Values
Must be flexible to work holidays as needed
Position requires weekend shifts
Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs
Bachelor’s degree in Biology or related field is required
1-3 years experience in cell based manufacturing in cell therapy/biopharmaceutical industry is required
Must have strong organizational and communication skills
Requires computer skills (Word, Excel), and use of a calculator
Must have ability to process, analyze and present data
Must be able to work effectively in a team environment
Cell therapy experience is a plus
Some knowledge of GMP/GTP regulations is preferred

176

Biotech Manufacturing Associate Resume Examples & Samples

Purification - Chromatography – Ultrafiltration – Virus Filtration
An understanding of process flow, aseptic technique and purification processes
Tertiary qualified desirable but not essential

177

Manufacturing Associate Resume Examples & Samples

Must be customer focused and exhibit leadership attitude
Take ownership of any issue
Complete all relevant paperwork following GDP/GMP guidelines
Troubleshoot process problems and respond to process alarms
Work with other groups such as maintenance/metrology to ensure preventative maintenance is done

178

Manufacturing Associate Resume Examples & Samples

Troubleshooting– Proficient at troubleshooting minor to moderate problems. Understands when and to whom to elevate
Logistics- Understands systems for purchasing routine items. Able to procure items and supplies
Planning– Consistently understands and provides feedback for operations occurring within the current work week
Processing Capabilities -Takes the lead during processing steps. Prepares the shift for upcoming processes
Project Performance -Able to lead a department team or moderate project with oversight. Consistently works as a project team member on Kiazen and other improvement initiatives
Training -Can successfully train newer team members on routine processes
Continuous Improvement -Actively performs as equipment and room owner. Applies 5S and TPM as required to improve area

179

Senior Manufacturing Associate Resume Examples & Samples

Support investigations
Point of contact for cross department request
Troubleshooting process and equipment failures
Label generation and revisions
Support new equipment implementation
Identify process improvements (Safety/Cost/Efficiency)
Support and write VSCRs, CAPAs, NCs, etc
Complete acquaintance with and understanding of the general and detailed aspects of the job, and their practical applications to problems and situations ordinarily encountered
5-7 years of work experience in pilot or commercial biologics manufacturing under cGMP with Bachelors
3-5 years of work experience with Master’s Degree
Decision making skills

180

Manufacturing Associate Level SF Resume Examples & Samples

Demonstrate proficiency at laboratory tasks, such as monitoring pH, conductivity, product sampling, etc. May train other associates on these tasks
Perform material movements, transfer materials and chemicals in, out, and across the production areas
Maintain facility and equipment through routine cleaning and sanitization, support 6S programs
Level of Experience in Manufacturing: Advanced. GMP setting preferred, and/or 24 months experience as an Associate Level II in bio-pharm industry
Strong written and verbal communication skills are required
The employee is living the cultural beliefs with the flexibility to adapt to changing business priorities, and is open to and actively seeks out feedback on their performance and translates that feedback into action

181

Manufacturing Associate Resume Examples & Samples

Ability to constantly, stand, walk push/pull and reach above shoulder level
Ability to push, pull, lift, and carry up to 50 pounds
Previous experience in a manufacturing or distribution environment
Strong personal initiative
Ability to maintain positive peer relationships
Excellent attendance and self-motivation
Ability to thrive in an ambiguous and changing environment

182

Experienced Manufacturing Associate Plant Resume Examples & Samples

Work in a safe manner and follow safe work practices and policies. Help ensure co-workers are working safely and following safety requirements
Engage in cross-training to maintain flexibility and adaptability to support resource planning
Operate manufacturing equipment and use hand tools as required
Support a respectful workplace
Perform other duties across the plant as needed as directed by supervision or management
PIT training/fork license required for some tasks
Ability to lift up to 50 pounds, perform tasks requiring repetitive motion and stand for long periods
Possess communication, teamwork, problem solving, and leadership skills
Dependability/punctuality

183

Dist / Manufacturing Associate Resume Examples & Samples

Operates production equipment including B/W printers, binders and trimmers to achieve shift production volume and meet safety and quality standards as described in the LSI operating manual. Must be able to operate two or the three workstations as assigned
Notifies lead operator and/or specialist when equipment is not operating effectively
Ability to walk and stand continuously during the assigned shift
Ability to lift/carry in full range of motion up to 50 lbs. during the assigned shift – up to 30 lbs frequently and up to 50 lbs occasionally
Ability to work designated 12 hour shift including overtime as required

184

Manufacturing Associate Level D Resume Examples & Samples

Perform hand soldering; become certified in leaded and no-lead soldering
Work from drawings, bills of material, object list and utilize small hand tools or lead forming machines to cut, bend or attach parts for assembly
Operate machines to include electro presses and various pre-adjusted lead forming machines
Conduct functional in-circuit test for departmental auditing
Conduct safety, housekeeping inspections
Receive, consolidate and put parts away. Perform data entry, pick job parts, process returned parts and non-conforming material

185

Manufacturing Associate Level A Resume Examples & Samples

Ability to lift and move heavy objects with or without accommodation
Ability to operate moving and lift equipment and climb tall ladders
Ability to work with heavy wiring, 8GA to 500MCM, and control gauge wiring, 24ga – 10Ga
Ability to follow DWI work instructions
Ability to read and follow schematic and wire tables
Ability to use overhead crane to lift an position heavy material and use multiply lifting devices
Understand basic Bill of Material structure
Use of specific tooling and equipment: Stud welder, Greenlee punch and heavy wire cutters
Use of tool crib power equipment: Band saw, chop saw, grinder, sanding wheel and drill press
Understanding of torque and fastener requirements

186

Manufacturing Associate Resume Examples & Samples

Experience using assembly equipment
Documentation of finished product
Knowledge of Standard Operating Procedures. (SOP's)
Working in an FDA/GMP regulated environment to include "Clean Rooms" and all the restrictions that are associated with a clean room environment
Previous experience with hand or machinery assembly of small parts is beneficial

187

Manufacturing Associate Resume Examples & Samples

Perform all stations on the manufacturing line
Visually inspects products to ensure quality is achieved
Hand-finish work on product, including tie tags, labels, and pre-ticketing and any other miscellaneous table work required
Utilize pallet trucks to assist with movement of finished product
Maintain cleanliness of work area throughout the shift and at the end of the shift
Report any conditions that need attention to appropriate personnel
Follow all company policies and procedures with regard to safety, quality, sanitation, personnel, maintenance, and equipment, including food safety
Performs other job related duties as assigned
Previous manufacturing experience and ability to operate electrical and manual pallet jacks a plus
Must be able to lift and carry up to 30 lbs. on a regular basis and to stand for several hours at a time as well as bend and stretch
Is flexible with work schedule to accommodate business needs
Must have proven abilities to work well within a team
Follow all company, regulatory and industry standards
Must have strong manual dexterity and hand/eye coordination

188

Manufacturing Associate Resume Examples & Samples

Understanding and compliance in Standard Operating Systems,
Current Good Manufacturing Processes cGMP Good Documentation GDP
Must possess good written and verbal communication skills; able to read and follow detailed written instruction
Must be able to work in a clean room environment wearing special garments and PPE

189

Purification Manufacturing Associate Resume Examples & Samples

Ability to work independently to develop and write documentation associated with Purification
Compliance to safety guidelines and current Good Manufacturing Practices (cGMP)
Follow standard operating procedures
Assist in Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and other validation needs such as IOQ and PQ
Analyze in process samples generated from purification activities by using pH/conductivity meters, scales, spectrophotometers etc
Practice a continuous improvement mindset by making suggestions on process improvements
Ability to work in fast paced, dynamic environment
Experience with Purification equipment such as columns, TFF, filling
Experience with buffer solution preparations within a cGMP environment
Experience with process development, tech transfer and optimization a plus
Good analytical skills to interpret and understand purification equipment and data
Ability to stand, walk, bend and reach for long periods of time
Ability to work flexible working hours
Effectively manages time and must pay attention to detail
Ability to lift and push up to 30 pounds or more
Experience with UNICORN software a plus
Experience with fermentation a plus
Basic knowledge of MS Office (Word, Excel, Outlook, Powerpoint)

190

Lead Manufacturing Associate Resume Examples & Samples

Understand and adhere to safety policies and practices
Follow Dry Room Procedures
Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR)
Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions
Maintain cleanroom standards, practices, and housekeeping according to standard operating procedures
Set up and operate manufacturing equipment
Clean and maintain equipment and work area
Use tools such as microscopes, tweezers, and other hand-held tools
Perform in-process inspection of components and assemblies to verify quality conformance
Recognize any issues from the equipment and any affiliated documentations and take appropriate corrective action within scope. Notify Supervisors of issues and discrepancies immediately.Communicate problems to manufacturing engineers
Assist engineers with product transfer activities and bill of material corrections
Report causes of process and/or documentation and assist or coordinate resolutions
Perform several basic Manufacturing operations or some complex manufacturing operations proficiently
Apply company policies and procedures to complete assignments
Conduct Shift PASSDOWN with peers
Follow production schedules
Follow acceptance criteria for equipment yield and efficiency
Monitor machines for problems and troubleshoot minor ones
Start and end batch runs
Email the Manufacturing Engineering group explaining any downtime problems/issues
Perform label printing responsibilities
Review DHRs
Prepare and verify materials to be used as issued to work orders
Submit work order completions
Understand and execute Line Clearance
Perform set-up and change-over on equipment
Train employees on products, processes and documentation.Training includes new hire orientation on Good Manufacturing Practices (GMPs), safety and chemical handling.Maintain training documentation
Verify labels
Red-line documents for revision changes
Perform line set-up and verification according to SOPs
Work closely with the product transfer and engineering teams on process and equipment issues
Provide timely notification to supporting groups (i.e., store shortage, manufacturing engineers, and process engineers) so servicing of line is performed in a timely manner
Lead assigned shift
Interact with material planning team to understand the needs required to meet the production plan
Understand all work requests, personnel support for these requests and effectively communicate schedules to Supervisor
Assure GMPs, housekeeping, safety and environmental guidelines are being followed correctly and consistently
Oversee movement of materials into clean rooms as well as movement of product out of clean rooms
Ensure batch records are complete and accurate
Identify and eliminate sources of inefficiencies
Assist in daily analysis of scrap to identify training/improvement opportunities in manufacturing processes
Prioritize production activities
6+ years of related experience
High School diploma/GED or equivalent experience
Experience in clean room assembly or Manufacturing in the medical device, pharmaceutical or biotech industry, or equivalent combination of education and experience
Experience in FDA or Kema audits
Knows how to read drawings
Understands GMP and Good Documentation Practice (GDP)
Must be a team player and able to demonstrate willingness and ability to provide assistance to anyone that needs assistance
Ability to clearly and effectively communicate with peers, supervisors, engineers, managers, leads and upper management.Able to understand any given instructions and batch records written and spoken in English
Ability to pay close attention to detail
Ability to solve basic math problems
Able to identify each station of the machinery
Able to contribute to the development of concepts and techniques
Must be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm/wrist motions
Ability to work directly with, handle or come into contact with chemicals or reagents

191

Manufacturing Associate Resume Examples & Samples

Responsible for maintaining a high level of cGMP
Reading, assisting in writing and executing instructions and reports
Close cross-departmental collaboration with other departments
You are a team-player - who takes ownership of your tasks!
Solid knowledge of cGMP is a big plus - and you have a high sense for quality and safety
Your knowledge of production equipment and procedures have been firmly established

192

Manufacturing Associate Resume Examples & Samples

Minimum one year of experience in a manufacturing environment
Minimum one year of machine operating experience
Must be able to push, pull, lift, and carry up to 20 pounds constantly, up to 50 pounds frequently and lift up to 100 pounds occasionally
Demonstrated reasoning and problem-solving skills
Satisfactory attendance performance

193

Manufacturing Associate Resume Examples & Samples

Ensure all safety equipment is worn correctly and safety procedures are followed
When traying, ensure that the correct size of tray is being used and that the tray came from the correct stack of trays, as the trays will be counted for each product
Check to see that the piece of meat to be trayed meets the specification by measuring the piece against one of three areas. They are as follows
Inch = is the width of the White spaced edging between the Tray conveyor and the Stainless steel edge
¾ inch = is the width of the white tray holder base
1 inch = is the width of the white strip between the center conveyor and the traying conveyor
Inch = is cut into the side of the same piece of white strip as above
You may have to scrape the bone dust off some of the products before traying
Make the product look as neat as possible by not letting any part of the product hang out side of the tray
Presentation of the product on the tray is the key to success in our business
The person that denests the trays may have to count out the correct number of trays for each product run. Ensure that the correct number is counted. If there are too many trays, it will confuse the person traying. Too few trays will result in the product piling on the table resulting in down time
Ensure work area is clean and free of safety hazards
Any piece of meat that falls on the floor or any unsanitary surface must be placed on the reconditioning table or discarded
Some key behaviour's that will prevent accidents that each employee must follow are: keep your mind and eyes on the task; keep your balance; understand and discover safe working procedures; keep healthy to avoid fatigue; avoid rushing; avoid complacency; avoid frustration
HACCP
Health & Safety Orientation
On the job training

194

Manufacturing Associate Resume Examples & Samples

Follow directions instructions at all times. Must be able to understand and follow written and verbal instructions in English (typically related to safety, quality, manufacturing processes)
Perform assembly and packaging operations based on written specifications
Perform audit of individual workstation and tool calibration
Work on-line where tasks vary as different models move along the line
Notify management regarding problems with the assembly or packaging process
Maintain safe and clean working environment by complying with procedures, rules, and regulations. Keep tools and equipment in clean, orderly condition daily
Follow inventory programs (in-process kanban) as specified. Assist in performing parts counts in the production/stockroom to maintain accuracy with inventory
Good use of hand tools such as: torque drives, needle nose pliers, screwdrivers, cutters, tweezers, scissors, extractor knives, tape guns, etc
Ensure quality; look for ways to enhance effectiveness and efficiency of the organization's systems, processes and tools
Assist in training manufacturing process to other associates as required
Cross train within the department to learn other skills and work processes
Use various cleaning solvents such as flux off 2000, alcohol, to clean assemblies as specified in documentation
Understand assembly and materials process flow by utilizing the MFG/Pro database
Verify all documentation prior to performing any operation to ensure documents are to latest revision in Agile Database
Contribute to team efforts by accomplishing expected results as instructed
Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork
High school diploma or equivalent, for the purpose of interpreting work instructions
Ability to effectively communicate in English – follow instructions, relay information, provide feedback and respond to questions both verbally and in writing
Knowledge of Demand Base Flow Manufacturing preferable
Must have the ability to create and maintain productive working relationships within the work team and with other functions
Ability to collaborate with peers to achieve shared departmental goals
Ability to cross-train other team members as needed
Good mechanical aptitude, dexterity and hand/eye coordination. Must be able to reach, bend and lift up to 25 lbs on a regular basis each day
Available to work OT when required
Organized approach and able to perform work as instructed
Good quality and safety work habits
Basic computer skills required (including Word, Excel)
Use of computer: 25%
Good vision and color perception due to close, exacting work and color coding of materials

195

Distribution / Manufacturing Associate Resume Examples & Samples

Operates production equipment including B/W printers, binders, trimmers, folder/gluer, shrink wrap tunnel, saddle stitch, and paper drill to achieve shift production volume and meet safety and quality standards as described in the LSI operating manual. Must be able to operate the various machinery as assigned based on work volume
Notifies supervisor and/or specialist when equipment is not operating effectively
Ability to work designated shift including overtime as required

196

Manufacturing Associate Resume Examples & Samples

Sets-up, operates and maintains production equipment. Responsible for the quality and efficiency of equipment assigned
Completes daily production records that have been assigned to work area and/or specific operations
Adheres to SOP-s and TQM policies and procedures relating to plant specific procedures
Abides by environmental, health and safety rules established for this operation
Participates in training as required
Ensures housekeeping and health and safety standards are maintained
Complies with policies and procedures pertaining to facility or divisional adopted standards such as TS 16949 and ISO14001
Utilizes the concepts or continuous improvement and cost reduction in the execution of the job function
Acceptable attendance is required
1st, 2nd, and 3rd shifts available
1-Year of manufacturing experience preferred
Physical requirements include: prolonged standing, bending, and stooping; using both hands to push, pull, grasp and pinch; ability to lift 20 lbs. Reasonable accommodations may be made to enable individuals with proven disabilities to perform the essential functions of the job
Measurement Skills-understanding and recording precise measuring equipment
Follows Directions
Flexible/Adaptable
Reading in English

197

Senior Manufacturing Associate Resume Examples & Samples

At least 2 years of college science in Cell Biology, Biochemistry, Chemistry, Biology, or a related field from a four-year college or university; and 4 to 6 years of related experience; or 6 to 10 years of experience and/or training or equivalent combination of education and experience
Science related training or courses
Able to work independently as part of a team or lead a team on assigned projects
Effective organizational and solid record-keeping skills

198

Manufacturing Associate Engineer Resume Examples & Samples

Generate/prioritize/monitor weekly/monthly projects
Manage Project Timelines
Support manufacturing with solutions in production. This will include developing, implement, and sustaining solutions on fabrication and assembly systems
Ability to balance a work cell and assembly lines
Understand and follow “Lock Out/Tag out Procedures”
Compiling and analyzing data for assembly lines and fabrication
CNC programming is plus
Participate in problem solving process
Participate in “Continuous Improvement Process”
Write technical procedures and summary reports
Contact suppliers as equipment is required
Bachelor’s degree in engineering or related field
Will accept associates degree or work experience as a substitute in lieu of education
Proven experience in sheet metal and assembly processes
Proven track record in project leadership
Have the ability to develop and implement standard engineering practices
Provide detailed documentation upon project completion
Strong history of personal and or project management
Minimum five years in an industrial environment
Good understanding of plant and environmental safety
Excellent communications, organizational, teamwork and computer skills

199

Manufacturing Associate Resume Examples & Samples

Perform element fabrication processes such as cutting media and mesh, pleating, squeezing, seam welding, swaging, end welding, etc
Concise reporting of production issues to management
Prepare and build weld fixtures
Ability to read and understand complex work instructions
Ability to work from production schedules
Ability to accurately use measuring devices
Usage of personal protective equipment as required
Adhere to all Company policies
Element fabrication and welding experience
Proficient in hand fusion welding strongly preferred
Knowledge and commitment to continuous improvement
Maintain an acceptable level of attendance (as measured by the Attendance Policy)
Experience in the preparation and maintenance of records as required
Requires a high school diploma, G.E.D. or equivalent. Experience in heavy manufacturing environment is desired
Must demonstrate good mechanical skills and troubleshooting capability
Ability to lift a minimum of 60 lbs. on occasion
Experience in fusion welding stainless steel strongly preferred

200

Manufacturing Associate Resume Examples & Samples

Possession of a Bachelor's degree from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education)
A minimum of five (5) years of progressively responsible job related experience or three (3) years of progressively responsible job related experience in a cGMP environment
Demonstrated experience in the area of operating/maintaining computerized and complex production equipment such as chromatography instruments
Experience writing/reviewing technical documents, SOPs and master production records and maintaining accurate documentation of laboratory procedures in accordance with cGMP
Working knowledge of cGMP Biopharmaceutical Sciences and operations and department specific computer applications
Ability to carry out processing and other manipulations under aseptic conditions
Ability to work flexible hours including occasional weekends
Ability to lift up to 35 pounds and work in a BL2 environment
Experience with equipment used for downstream purification and clinical manufacturing
Ability to operate equipment such as Amicon K-Primes, Akta purification units, Bioprocessing purification units
Experience in virus purification
Ability to perform in-process tests such as gel electrophoresis, HPLC, etc

201

Manufacturing Associate Resume Examples & Samples

Perform in-process immunoassays to obtain data for the manufacturing of components and kits
Manufacture kit components, including formulation, filling, labeling, and kit packaging
Perform routine preventative maintenance on assigned instruments and equipment according to established schedule and procedure
Monitor inventory and plan and schedule production
Work closely with the Product Development group to ensure proper transfer of new product from Product Development to the Manufacturing group
BS/BA in Biology or related Life Sciences area
1 year Biochemistry industry laboratory experience

202

Manufacturing Associate Resume Examples & Samples

Minimum HS or GED required
Must be able to perform repetitive movement of hands/arms for the duration of the shift
Must be available to work flexible shifts
Ability to repetitively lift 45lbs
Gowning and ongoing cleaning/sanitation throughout the shift required
Ability to read, write, accurately perform basic math functions

203

External Manufacturing Associate Resume Examples & Samples

The EM Associate performs all responsibilities in accordance with company policies, procedures, and regulatory requirements
Liaison between Regeneron Quality Control, Quality Assurance, Operations/Logistics, process Sciences, Supply Planning, Formulation Development and CMC Regulatory Departments and contract manufacturers or business partners
Ensure the timely routing and review of all master batch manufacturing records (MBMRs), standard operations procedures (SOPs), tech transfer reports, validation master plans, and other documentation related to clinical and commercial drug product manufacturing at contractors and/or business partners
Support EM oversight of activities at CMO’s through the review of Manufacturing Batch Records, Protocols and Reports to ensure compliance with current regulatory expectations, e.g. EU, FDA and Corporate Standards and Internal Procedures
Supports activities at contract and/or business partner manufacturing sites, including but not limited to: supplying of requested materials, directing shipments, tracking of outputs and project step completion times, and providing any required associated reports
Works closely with internal cross-functional areas to resolve open issues in a timely manner. Completes and /or reviews deviation investigations as required; including performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending
Serve as support for Technical Transfer, maintaining knowledge of industry standards and regulatory requirements to insure all product manufacturing, storage and shipping are compliant
Ensures the maintenance of product integrity and company reputation
Travel to contract manufacturers or business partner sites, as required
Must have detailed knowledge of industry best practice and current regulatory expectations concerning sterile drug product or medical device manufacturing
Must have direct experience performing review of Manufacturing/Validation/Quality documentation in cGMP biopharmaceutical /drug substance or aseptic processing
Experience working with contract manufacturing organisations an advantage
Ability to provide project support for successful completion of EM projects. PMI certification or equivalent would be an advantage
Excellent written and verbal communication and negotiating skills. Proficiency in French or German would be an advantage
Risk assessment and risk management experience an advantage
Ability to exercise judgment with defined procedures and practices to determine appropriate action
Ability to prioritize, monitor and report on daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment

204

Lead Manufacturing Associate Resume Examples & Samples

Demonstrates innovative technical knowledge and significantly contributes to the overall production efficiency
Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation
Remains current regarding current Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies production methods to fully address compliance issues
Analyzes scientific data with accuracy and precision, critical at time of processing
Authors Batch Production Records, complex Standard Operating Procedures (SOP’s), Product Specification Sheets, and Solution Preparation Records as needed to accurately reflect manufacturing processes
Reviews Equipment/Suite logbooks
Provides leadership in the startup and validation efforts for the Manufacturing Facility and may represent Manufacturing during Factory Acceptance Testing of new equipment
Possesses sound scientific knowledge and understanding of manufacturing processes and uses this skill set to routinely monitor manufacturing processes and recognize potential process issues as they arise
Works with senior manufacturing personnel to improve and optimize manufacturing methods
May provide feedback to area management on junior staff performance
Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility is required
Must have commercial Biologics manufacturing experience
Experience with bioreactors is preferred
Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards (i.e. vacuum pumps, pressurized vessels), dangerous materials (i.e. chemicals, solvents, pathogens), freezer burns, allergens and strong odors
Based on work assignment, may be recommended to have medical testing in accordance with the company’s Occupational Health Program
Holiday and shift work often required based on manufacturing schedule as determined by Area Management

205

Manufacturing Associate Resume Examples & Samples

Systems
High School Diploma, GED, equivalent or higher
One year minimum CNC experience
Experience with Excel, Word, Power Point
Ability to frequently bend, sit, stand, walk, push/pull, reach above shoulder level
Ability to frequently carry/lift medium loads (21-50 lbs) and occasionally carry/lift heavy (51-100 lbs)
Previous machine operating, pre-production or tooling experience

206

Manufacturing Associate Resume Examples & Samples

Develop a process understanding of primary work areas
Execute activities on manufacturing floor in accordance with schedule; involves effective communication and working with other departments
Provide a moderate level of troubleshooting and diagnosis and assist with repair of equipment such as columns, vessels, skids, and CIP/COP systems; may include executing simple preventive maintenance tasks
Basic knowledge of Delta V, PLC-based process control systems, Human-Machine Interface (HMI) configuration
Basic knowledge of instrumentation and mechanical systems such as controllers, indicators, analyzers, control valves, sensors, pumps, etc
Ability to gain in depth process understanding of primary work areas and manufacturing techniques (e.g. Buffer preparation, fractionation, purification, fill, finish)
Must have customer services attitude and willingness to assist with any maintenance related problem
AA or equivalent plus at least 1 year of experience or
High School diploma with at least 3 years of experience
Must have working knowledge of scientific principles
Scientific or technical degree preferred

207

Manufacturing Associate Resume Examples & Samples

Perform daily purification steps in a cGMP manufacturing environment
Work in hands-on capacity to operate chromatography systems, ÄKTA chromatography controllers, UF/DF skids, perform sterile filtrations, prepare production buffers, and clean equipment as required
Assist in the resolution of manufacturing deviations/non-conformances
Assist with troubleshooting processes and equipment
Assist with process, equipment, and cleaning validation initiatives
Ensure work is completed in compliance with approved SOPs, batch records, and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed

208

Manufacturing Associate IV Dispensary Resume Examples & Samples

Intermediate level of understanding of biopharmaceutical production and theory
Assists in execution of validation protocols
Capable to work a 12-hour shift, both day shift or night shift

209

Manufacturing Associate Resume Examples & Samples

Able to complete various forms in a neat and legible manner
Able to read, write and speak the English language
Able to maintain or attain established production

210

Manufacturing Associate Resume Examples & Samples

Perform all essential functions related to antibody purification manufacturing, including centrifugation, making buffers, using the spectrophotometer, running SDS-PAGE gels, and performing endotoxin tests
Perform basic math calculations to determine the concentration and amount of antibodies
Perform column chromatography manually as well as using FPLC
Use of ERP database to execute production orders
Bachelor’s Degree in Biochemistry, Biology, Chemistry, or a related field
1-5 years of experience in antibody purification or protein purification
Solid understanding of antibody structure and hands-on experience with chromatography
Good computer skills
Previous experiences with automated purification system such as AKTA

211

Tempoary Assembly & Manufacturing Associate Shop Garp Tech Resume Examples & Samples

Assist the production team with various phases of assemblies
Cable cleaning & Sandblasting clamps in Sandblast pit, disassembly and assembly of clamps
High School diploma or G.E.D.; or
6 months of related experience and/or training; or
No vision hindrances in relation to color (not color-blind)
Ability to read/learn various manufacturing drawing types. Ie. Schematics, layouts, diagrams, etc
Ability to approach people to ask questions
Ability to work in extreme hot or cold environment

212

GMP Microbial Manufacturing Associate, / III Resume Examples & Samples

High School Diploma plus 5+ years of experience in microbial production (E coli, Pichia, Bacillus) – OR –
B.S. in a Life Sciences discipline and 3+ years of relevant experience – OR –
M.S. in a Life Sciences discipline and 2+ years of relevant experience
Experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work with cell culture reactors and with processes to produce bulk biologics (proteins, antibodies, etc.)
Have the knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
Well-versed in Good Manufacturing Practices (GMPs)
Mature professional capable of independent work
Have good understanding and knowledge of aseptic microbiologic techniques and processes
Experienced in SIP stainless fermentation equipment bioreactors (New Brunswick, Sartorious)
Experience in producing Master and Working cell banks
A good understanding of Good Manufacturing Practices including documentation
Ability to produce results in a fast-paced environment, under minimal supervision while leading junior staff
Able to work in a team setting and independently under minimum supervision
Creative individual with excellent trouble shooting skills

213

Manufacturing Associate Resume Examples & Samples

Operating molding equipment and/or second operation machines
Inspecting, trimming, testing, fixturing, assembling and packaging plastic products
Verifying product visually and takes corrective action when necessary
Ensuring product is consistent with established specifications
Escalating quality issues as appropriate

214

Manufacturing Associate Resume Examples & Samples

Cell culturing of hybridoma cell lines with repetitive use of pipette/pipette aid and working in a biosafety cabinet
Subcloning of hybridoma cells with frequent use of micro-pipettes and multi-channel pipettes
Documentation in lab notebooks, controlled forms, spreadsheets, and databases
Written and verbal communication with colleagues within the TC department as well as colleagues in the Purification labs and with scientists and supervisors managing projects
Adaptation of cells to different media and growth conditions and methods
Banking of hybridoma cells for cryogenic storage
Performing cell counts using a hemacytometer
Use of a CO2 incubator
Bachelor’s Degree in a Life Sciences related field
1 year of tissue culture experience with hybridoma cell lines
Sterile technique in a biosafety cabinet
Tissue Culture experience in a production environment
Exposure to hands-on tissue culture, especially mammalian cell lines

215

Manufacturing Associate Resume Examples & Samples

Operate and maintain equipment in the production of media-made elements
Produce complicated components needed, subassemblies and final assemblies in related area to blueprint and work instructions
Work under the direction of supervisors, or more experienced personnel, with little supervision
Setup and operate all equipment in related area to produce product to specification requirements
Must follow all safety procedures and wear required P.P.E. at all times
Assist lower classification personnel and be willing to cross train as needed
Maintain clean, neat and safe work area
Must have High School diploma or equivalent
Experience in manufacturing and assembly desired
Maintain accurate records, logs and collect necessary data
Maintain an acceptable level of attendance

216

Manufacturing Associate Resume Examples & Samples

High School diploma or GED, equivelant, or higher
Ability to push, pull, lift, and carry up to 20 pounds constantly, up to 50 pounds frequently and lift up to 100 pounds occasionally
At least 1 year of work experience, which required the ability to read prints, measuring tapes and calipers
Mathematical skills to read, understand, and calculate decimals

217

Senior Manufacturing Associate, nd Shift Resume Examples & Samples

Be a consistent contributor on an evening shift, under the guidance of a shift leader
Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation
Utilize knowledge to improve operational efficiency
Adhere to documented waste handling procedures to respect environmental regulations
Bachelor’s degree and 3-5 years of experience in a GMP manufacturing environment

218

Manufacturing Associate Resume Examples & Samples

Interested candidates must upload a resume in order to be considered.**
Enters set-up code, run code and related comments into work station computer
Sets up and adjusts machine to accurately fit specs
Runs machine to produce product to proper customer specifications
Inputs total piece, finished product, unit and scrap counts into work station computer
Directs and works along with other operators to complete set-up procedure and production run in the most efficient time and manner for each order on equipment assigned to operate
Performs assistant operator duties
Provides assistance throughout the production area
Performs clean-up activities in production and on the grounds as assigned
Regular and reliable attendance
Follows all quality set-up, run and check out procedures for accuracy and quality
Knows, understands, and follows all plant safety rules and policies and procedures
Basic math & reading skills
Possess good problem solving and troubleshooting skills and safety practices
Must be able to stand and walk through the required length of the shift (8-12 hrs.)
Must pass a pre-employment drug test and background check
Candidates must be willing to work a swing (or rotating) shifts
Candidates may be required to work overtime, doubletime, and weekends as necessary

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