QC Microbiology Resume Samples

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C Bartoletti

Carmela

Bartoletti

911 Orville River

Dallas

+1 (555) 829 2617

911 Orville River

Dallas

Phone

p +1 (555) 829 2617

Experience Experience

Philadelphia, PA

Supv, QC Microbiology

Philadelphia, PA

Heller-Romaguera

Philadelphia, PA

Supv, QC Microbiology

Performs final review of test data/reports to ensure conformance to the established specifications and other related standard operating procedures
Schedules and coordinates a wide variety of testing among several laboratory technicians and may perform some associated supervisory duties
Manages project timelines as it pertains to QC Microbiology Technical Service support
Proficient in Biological Indicators specific to vessel qualifications and sterilization cycle development
Assists with or prepares annual department budget
Interfaces with a Sustaining Engineering, R&D, and Sterilization Engineering regarding new or changes to existing products and processes
Proficient in Microbial Identification methodology (i.e. Vitek, MALDI-TOF, Sequencing)

Detroit, MI

QC Microbiology Supervisor

Detroit, MI

Runolfsson, Prosacco and Collier

Detroit, MI

QC Microbiology Supervisor

Delivery of area performance to meet or exceed performance or quality goals
Project Management qualification such as, Project Management Professional
Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department
Develops microbiological testing methods including validation of test methods
Collaborate with the QC System Specialist to develop and implement LIMS for the Microbiology Laboratory
Contribute to site management operational and strategic initiatives
Monitor the EHS performance in your department

present

Philadelphia, PA

QC Microbiology Lab Technician

Philadelphia, PA

Upton-Stoltenberg

present

Philadelphia, PA

QC Microbiology Lab Technician

present

To perform the checks on incoming culture media
To perform the water samples
Ready to work in shift
Analyze the samples of water and sent products according to the specifications in force
Reading and interpretation of environmental monitoring data generated in his various areas of Manufacturing
Written and spoken French, good knowledge of English is an asset
Languages: French, English technical

Education Education

Bachelor’s Degree in Microbiology

University of Georgia

Bachelor’s Degree in Microbiology

Skills Skills

Delivery of area performance to meet or exceed performance or quality goals
Liaising with external vendors
Training of area personnel
Participate in corporate/regulatory audits
Co-ordination of area resources
Contribute to site management operational and strategic initiatives
Supervision of area personnel
Ensure compliance with cGMP and other business compliance regulations
Lead, promote, participate and supervise the implementation and maintenance of the EHS programmes relevant to you
Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up CAPA’s assigned to you

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15 QC Microbiology resume templates

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QC Microbiology Associate Sterility Testing Resume Examples & Samples

Manages all outsourced sterility testing and qualifications
Coordinates with contract laboratory and clients, and serves as main contact for Althea for sterility testing
Responsible for maintaining clinical and commercial sterility test compliance with multi-compendial requirements
Prepares precise and timely sterility test qualification, validation protocols and reports
Compiles data for documentation of test procedures. Analyzes data and results, presenting conclusions to manager
Reviews and approves sterility test reports from contract laboratory
Develops and implements new testing methods with guidance from manager
Initiates revisions to current cGMP and SOP guidelines
Embodies Althea’s cultural values and aligns daily interactions with department goals and company culture

Supervisor of QC Microbiology Resume Examples & Samples

Supervises the daily QC Microbiology operations to support Biologics and Fill Finish manufacturing
Ensures implementation and maintenance of quality systems, including but not limited to, SOP writing, deviations, technical report review and employee training
Trains staff and new employees on quality control methods and procedures
Reviews all batch records, deviations, and validation protocols
Prepares environmental monitoring trend reports
Oversees environmental action level reports and investigations
Serves as a liaison between the Company and auditors
Represents department in internal and external meetings
Conducts routine and non-routine analysis of raw materials, in process, and finished formulations according to standard operating procedures
Performs environmental monitoring of the cleanrooms as necessary
Ensures adherence to cGMP requirements and SOPs
Develops new testing methods including validation of test methods
Reviews data obtained for compliance specifications and reports abnormalities
Makes recommendations for corrective action necessary to assure conformity with quality specifications

QC Microbiology Supervisor Resume Examples & Samples

Ensures implementation and maintenance of quality systems, including but not limited to, SOP writing, deviations, technical protocol/report review and employee training
To coordinate environmental monitoring execution and prepare trend reports
To coordinate purified water monitoring execution and prepare trend reports
Ensures the compliance of routine microbiology laboratory operation, such as: media preparation, growth promotion test, and microbiological culture management
Supervises and conducts routine and non-routine analysis of raw materials, in process, and finished formulations according to standard operating procedures
Develops microbiological testing methods including validation of test methods
Responsible for auditing technical reports and supporting data
Analyzes data and results and provides conclusions and proposals for future directions; capable of critical review

QC Microbiology Lab Technician Resume Examples & Samples

To perform the water samples
Analyze the samples of water and sent products according to the specifications in force
Ensure all necessary documentation to trace each analysis: No. lot and preparation of reagents, equipment used, calibration, batch number and expiry consumables .
To prepare adequate reports, encode certificates of analysis and provide the coordinator and / or team leader to the reports, certificates of analysis and the raw-data related to correction before approval
Read the results of environmental controls and encode the results in the database validated
To perform the checks on incoming culture media
In case of non-compliance, immediately inform the coordinator and / or the team leader and apply procedures
The cleanliness and order of his desk and the laboratory in general
Equipment for the laboratory (s) is (s) he regularly checks the cleanliness, documentation, maintenance and validation
To follow all safety instructions and to use any equipment at his disposal to ensure his safety and that of his colleagues
Degree: technician biochemist / biology / A1 sciences / equivalent
Languages: French, English technical
Basic knowledge of Windows
Shift job

QC Microbiology Scientist Resume Examples & Samples

Method and equipment validation related to: sterility/bioburden/endotoxin testing, and microbial identifications
Technical writing including: position papers, validation reports, and microbiological investigations
Organism culture, research, and characterization for use in investigations and cleaning development
Reviews new test procedures and assays
Evaluate and acquire new methodologies, techniques, and equipment as needed
Oversee Contract laboratory testing
Set product specifications and alert/action levels
Lead technical troubleshooting and problem investigations
Review assay, process, and equipment validation reports, as well as, other technical documents for technical correctness and regulatory compliance
Coach junior member of the team for good microbiology lab practice and modern aseptic techniques
Lead in the audit of vendors, external laboratories, business partners, and contracted manufactures as needed
Support and participate in regulatory inspections
Strong background in pharmaceutical microbiology, GMP working experience in QC lab and aseptic techniques are required
Strong investigational skill, working knowledge of microbiology assay development and validation are needed
Advanced knowledge of aseptic manufacturing operations required
Requires PhD in Microbiology or related field with 3+ years’ experience working in a GMP manufacturing industry
Experience with electronic systems such as LIMS, SoftMax, Empower, Statlia, Qumas, eDoc, Trackwise etc., is an advantage
Proficient in the use of Microsoft products including, Excel, Word and PowerPoint

Manager, QC Microbiology Resume Examples & Samples

Must have demonstrated expertise and knowledge of sterility testing using specialized equipment (e.g. BacT) and diagnostic microbiology
Must have demonstrated computer literacy skills (e.g. Microsoft Office Word and Excel, etc.) Should have demonstrated proficiency in LIMS or other trending database applications
Statistical process control- Six Sigma GB / BB Certification is a plus
Experience with inspections/audits by the FDA and other regulatory agencies
Thorough Knowledge of cGMP/QSR and FDA device/drug/biologics regulations
Conducting and Leading Root Cause investigations
Experience in developing and making formal presentations
Familiarity with technology transfer and building a quality infrastructure to support commercialization
Proficient in MS Office applications and MS Project
Ability to independently prioritize and successfully manage complex and competing projects
Strong troubleshooting and problem solving skills
Strong team leadership and staff development skills

QC Microbiology Lab Technician Resume Examples & Samples

Level graduate or equivalent experience
Experience working in aseptic area with aseptic manipulations
Minimum 1 year experience in a microbiology laboratory is an asset
Scientific and analytical skills
Autonomous, results oriented and team spirit
Written and spoken French, good knowledge of English is an asset
Knowledge of MS Office such as Excel, MS Word and Outlook

QC Microbiology Supervisor Resume Examples & Samples

Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements
Supervise a team of micro laboratory analysts
Validation/Qualification of Microbiology test methods and test systems such as the Endotoxin test system, Sterility Test Isolator and Identification system
Collaborate with the QC System Specialist to develop and implement LIMS for the Microbiology Laboratory
Lead and participate Quality Risk Assessments relating to the Microbiology
Maintain regulatory compliance through the creation and maintenance of programs for laboratory testing, training, SOPs and validation. Preparation of documentation for audits carried out by internal auditors and Regulatory bodies
Close out of actions/ recommendations identified from both internal and external audits
Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate. To maintain competence and keep up to date with all new technologies, procedures and methods used in the Microbiology Laboratory. . Perform technical review of data generated in laboratory, validation protocols and reports. To represent the Microbiology laboratory at internal and external meetings in the absence of the Laboratory Manager. To keep management updated on issues arising within the laboratory. To report to and be directed by the Laboratory Management and to organize and schedule the smooth running of the laboratory in the absence of the Laboratory Manager. Provision of trouble shooting and similar expertise in the resolution of laboratory issues as they arise from time to time utilizing Root Cause analysis tools To ensure a high standard of housekeeping is maintained in the Laboratory
To travel and represent the organization as may be required for technical knowledge and ability
To ensure all instruments/equipment are maintained in a calibrated and operational state
Provide Technical support to Manufacturing and Projects which the company undertakes through project participation, investigation, validation and testing activities and prepare Technical Reports as required
Scheduling of testing, review and authorization of microbial data
Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Microbiology Associate Director, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time on TrackWise
Minimum of 4 years of experience in cGMP Quality environment
Experience in environmental and facilities monitoring, testing of sterile drug product , raw materials and aseptic filling process of sterile pharmaceutical /biopharmaceutical products
Subject Matter Expert in Method Validation, Endotoxin testing
Experience in Sterility and Identification testing desirable
Excellent knowledge of LIMS and experience in the setting up and implementation of LIMS for Microbiology
A high degree of technical competency in Sterility Assurance, Aseptic filling and microbiology methods
Ability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals
Excellent problem solving and root cause analysis skills
Routinely takes an innovative approach in developing processes and procedures that are both efficient and compliant

QC Microbiology Specialist Resume Examples & Samples

Functioning as the Subject Matter Expert for general Microbiology methods possessing strong troubleshooting capabilities
Excellent knowledge of validation, investigation, execution of Microbiology methods and data analysis
Excellent communication (written and oral) skills as an individual contributor. The ability to lead cross functional teams focused on issues related to general Microbiology methods
Support of regulatory submissions and agency queries
Performs gap analysis on methods
Makes recommendations for and manages method gap remediation
Maintains knowledge of current industry practices relative to Microbiology activities
Manage day to day activities in the lab across Microbiology functional groups. Can lead the team and be a key decision maker in the absence of Microbiology management
Experience in validation of Microbiology methods in a GMP environment
Experience in laboratory investigations and root cause analysis in a GMP environment
Good working knowledge of electronic systems including Trackwise, LIMS, as well as electronic documentation management systems
Detail oriented and able to function as a self starter

Scientist, QC Microbiology Resume Examples & Samples

Comply with all job related safety and other training requirements
BS/BA with a concentration in Chemical or Biological Science plus 3 years laboratory experience OR
AAS in a physical or biological science plus 4 years experience in a laboratory; OR
Five (5) years experience in a pharmaceutical or related laboratory
Broad knowledge of analytical, chemical or microbiological techniques
Knowledge of methods development approaches, analytical validations, quality control statistics, documentation and adherence to SOPs
Ability to write technical reports and deliver effective oral presentations
Ability to effectively collaborate with others to achieve team goals and expectations
Interest in researching and implementation of new approaches in analysis
Ensure that the lab is maintained in a safe operating condition as per company safety standards
Participate in safety discussions/committees as needed

Scientist, QC Microbiology Resume Examples & Samples

Performs analyses including instrumental and automated methods utilizing prescribed procedures and techniques
Generates valid data, reports results on appropriate database compared to established specifications while adhering to GMPs
Compares laboratory results with specifications for acceptability and determines if repetition or OOS is required
Maintains equipment and troubleshoots instrumentation problems, procedural problems or production problems
Writes and reviews SOPs and revises analytical procedures as needed
Schedules activities to meet target dates for customer needs
High school diploma and 3 years of job related experience; or
AA/AS degree plus 2 years of job related experience; or

Senior Analyst, QC Microbiology Resume Examples & Samples

Prepares schedules, sample labels and controlled document forms for sampling water and steam systems in accordance with SOP requirements
Performs Quality Control Testing of BET reagents, Microbiological Testing Media, and Biological Indicators
Performs microbial isolation techniques, gram stain and supports microbial identification process
Written and review Technical and business documents
Performs QC Microbiology related Deviation Investigations and Corrective Actions
Serve as author of department operating procedures
Prepares written monthly/yearly QC Microbiology trend reports
Prepares protocol, summary, document change and investigational reports as needed
Reviews data generated by other Analysts and ensures compliance with cGMP, USP, EU and other regulatory requirements at all times. Records and interprets data results
Provides review and revision of procedures and controlled forms
Provides training and mentoring other analysts
Performs general laboratory duties
Receives laboratory samples, reagents, chemicals and testing media
Supports special project under the guidance of QC Microbiology Management
Performs other tasks as designed
Proficient in MS Word, Outlook, and Excel programs as well as PowerPoint, Project and Visio
Intermediate ability to interpret / write complex business and technical documents
Requires strong presentation development and delivery skills
Ability to deal appropriately with regulatory agencies
Advanced knowledge of cGMP, OSHA, DEA, USP, EP, and other regulatory guidance documents
Requires flexibility and ability to multi-task, strong organizational and time management skills
Advanced critical reasoning and decision making skills for solving routine and complex problems that impact multiple departments
Bachelor’s degree preferred
3 years’ relevant work experience required, preferably in a manufacturing environment with cGMP requirement
An equivalent combination of education / experience may substitute

Manager QC Microbiology Resume Examples & Samples

Ensure department metrics and cycle times are monitored and achieved
Provide management and direction to microbiology laboratory staff
Oversee daily operations and address lab needs
Monitor environmental monitoring and testing schedule, progress, data and work quality
Direct the efforts and study design for qualifying new utility systems and classified areas
Assist manufacturing and facility departments to solve microbiology related deviation issues
Maintain product timeliness
Assist in creation, implementation and administration of microbiology based programs
Excellent interpersonal and leadership skills and abilities
Ability to interpret and communicate information
Requires BA/BS in microbiology, or closely related field, with at least 7+ years’ experience in microbiology lab, preferably in the pharmaceutical or biotech industry with 3-5 years of that experience in a leadership role in microbiology laboratory management
Level determined based on experience

Associate Director / Director QC Microbiology Resume Examples & Samples

To provide management and direction to microbiology laboratory staff
Oversee daily operation & address lab needs
Conduct trouble-shooting and OOS investigations
Maintain project timeliness (i.e. implementation of new equipment, methods, room/utility PQs, etc.)
Represent QC during regulatory inspections to respond and address microbiology issues and solutions
Strong microbiology lab operation management skills
Strong analytical and investigational skills
In depth knowledge of pharmaceutical microbiology, including endotoxin testing and bioburden testing
Knowledge of Pharmaceutical Water systems and HVAC systems
General knowledge of biotech process, equipment and their microbiological control

Analyst, QC Microbiology Resume Examples & Samples

Ensures compliance with current Good Manufacturing Practice (cGMP), USP, EU, BP, JP and other regulatory requirements at all times
Performs routine Microbiological Testing such as Bioburden, Bacterial Endotoxin and Sterility Testing on Water, Raw Materials, In-Process, Finished Products and Components
Demonstrates aseptic technique when performing a Microbiological Test
Collects water samples from AWFI, WFI, DI Feed and Pure Steam ports used to support manufacture drug products
Supports testing (Biological Indicator and Endotoxin Indicators) for the Validation Department Depyrogenation and Sterilization Qualifications
Executes basic protocol requirements
Provides review and revision for SOPs and Controlled forms
Operates laboratory equipment used to provide sterile and depyrogenated materials
Monitors and/or orders laboratory supplies and materials
Performs other tasks as assigned
2 years relevant work experience required, preferably in a regulated manufacturing environment with cGMP requirements
An equivalent combination of education, experience and training may substitute

QA Plant Support & QC Microbiology Mgr / TL Resume Examples & Samples

The QA Plant Support / QC Microbiology manager will be responsible for planning, organizing, supporting and supervising personnel working with the following: QA Plant Support functions, QC Microbiology, and Stability
The successful candidate will be responsible for managing a team of professionals and technicians
The manager will be responsible for development and reporting of various metrics to assure that management in Operations & QO are aware of the status of compliance
The manager will be accountable for the efficiency, accuracy and service levels of unit personnel and is expected to support daily operations and budget
The manager will also be expected to initiate & lead improvement projects
The manger is expected to learn and manage other responsibilities as assigned
The manager is responsible for being a primary contact for the escort & facilitation of visits by outside regulatory agencies and other related GMP/ISO compliance inspectors. The manager will act as an integral part of these onsite audits
The manager will have responsibility for supporting QO programs within the operating unit
QA ROLE QUALIFICATIONS
Bachelors degree in a Science-related field with 7-10 years of quality operations experience
Two+ years supervisory experience preferred
Strong working knowledge of the company's Good Manufacturing Practices and current regulatory and compendial requirements
Strong interpersonal, oral and written communications skills
Demonstrated successful interaction with all levels of personnel is required
Demonstrated knowledge of Quality Assurance principles
Well aligned with the Zoetis Core Beliefs
NOTE: Candidate must not be Cephalosporin sensitive

QC Microbiology Resume Examples & Samples

Perform testing and data review for micro methods including bioburden, sterility and endotoxin
Experience in aseptic technique
Demonstrated ability to produce quality results under direction
Technical expertise for executing analytical test methods in one or more of the following areas: micro methodology, bioburden, sterility, and endotoxin testing
At least 2 years of relevant experience within an academic/pharmaceutical/biotechnology organization

Senior Supervisor, QC Microbiology Resume Examples & Samples

Supervision of all QC Micro laboratory testing
Sustain environmental monitoring program for Kite
Management and optimization of the Aseptic gowning training and qualification program
Work with QC raw materials team to establish specifications and testing process of raw materials
Monitor and trend data

Manager QC Microbiology Resume Examples & Samples

Strong microbiology lab management skills
Solid GMP compliance and inspection experience
Technical writing experience including SOPs, investigations, and validations
Requires BA/BS in microbiology or closely related field with at least 7 years’ experience in a microbiology lab, preferably in the pharmaceutical or biotech industry. Management experience required
Level will be determined based on experience

QC Microbiology Assoc Resume Examples & Samples

Collect and organizes data for Microbiology identification trend
Responsible for routine environmental monitoring, finished product, stability, and utilities sampling and testing under close supervision of senior staff
Interpret and apply specifications and operating procedures when carrying out monitoring and testing responsibilities
Review verification of environmental monitoring, raw materials, and finished product data sheets
Responsible for the general cleanliness and appearance of respective lab by keeping laboratory equipment, supplies, and overall environment in good operational status
May prepare media reagents, testing materials, and equipment as required
Order and maintain materials, supplies, office inventory and data sheets a required
Records data in controlled notebooks, controlled data sheets, validated spreadsheets, and completes analysis report forms
May be required to work on special projects such as investigations, and non-routine testing
Maintains neat and legible records
Promptly and accurately inputs data into Sapphire LIMS
Follows cGMPs, GLPs, SOPs, USP, and FDA guidelines in all appropriate functions and notifies Supervisor, Exempt, or Lead of any observed discrepancies in laboratory or plant operations
Evaluate and trend environmental monitoring data
Become proficient in environmental monitoring techniques specific to Duplex Microbiology
Become proficient in finished product and raw material testing as required, i.e. Sterility, LAL, and Electronic PM
Learn to write and edit environmental monitoring and laboratory procedures dependant upon experience
Become proficient in Microbial techniques such as Gram staining, kilutions, filtering, and evaluation of plates and test tubes for microbial growth
Initiate and/or conduct the investigation for non-conformance of routine testing specifications dependant upon experience
Understanding of aseptic laboratory and manufacturing processes
Knowledge in CFR, USP, cGMP, GLP, and other FDA regulations
Knowledge and experience in microbiology and sterilization validations
Ability to use Microsoft Office (Word, Access, PowerPoint, Excel)
Excellent organizational skills with the ability to adapt to changes
Without 4 year related college degree: 3-5 years related experience
With 4 year related college degree: related experience is desirable
BS degree in Microbiology or related field

Supv, QC Microbiology Resume Examples & Samples

Schedules and coordinates a wide variety of testing among several laboratory technicians and may perform some associated supervisory duties
Performs final review of test data/reports to ensure conformance to the established specifications and other related standard operating procedures
Investigates deviations to determine the impact on the product quality, the cause and corrective actions to preclude further deviations of a similar nature
Reviews technical reports and other sources of information to ensure that laboratory practices are consistent with current industry and regulatory requirements. Disseminates related information and updates procedures to reflect current technology
Prepares protocols and technical reports for validating changes to existing products and processes such as Container Closure Integrity, Cycle Time Reduction studies or other testing as needed
Interfaces with a Sustaining Engineering, R&D, and Sterilization Engineering regarding new or changes to existing products and processes
Manages project timelines as it pertains to QC Microbiology Technical Service support
Interfaces with a wide variety of disciplines to evaluate applicability of existing methods
Assists with or prepares annual department budget
Proficient in Biological Indicators specific to vessel qualifications and sterilization cycle development
Proficient in D & z value using the BIER vessel
Proficient in Microbial Identification methodology (i.e. Vitek, MALDI-TOF, Sequencing)
Proficient in media qualifications of incoming and purchased media & reagents
Proficient in preparation of spore suspension preparation
Lead routine investigations related to laboratory deviations and out of specifications
Evaluate and trend environmental monitoring and product testing microbial identification data annually
Review completed controlled data sheets, notebooks and validated computer spreadsheets to ensure compliance to existing specifications and standard operating procedures
Investigate unexpected protocol discrepancies generated by testing in the QC Microbiology Technical Services laboratory
Train laboratory technicians in all processes relevant to QC Microbiology Technical Services
Order supplies necessary for the successful operation of the QC Microbiology Technical Services laboratory
Self-motivated with the ability to initiate, develop, and institute new projects and special studies
Write and edit laboratory procedures
Problem solve in the laboratory
Computer knowledge
Theoretical knowledge of subject matter, CGMP, FDA guidelines, ISO guidelines, GLP and USP’s
Ability to work effectively in a multi-cultural environment
High energy, people oriented individual with the ability to develop and to motivate subordinates
Good organizational skills with the ability to promote and adapt to changes
Must be able to operate independently, analyze information, and make quality decisions under pressure
BA/BS degree in related science
Minimum of 2 years of previous supervisory experience
Minimum of 4 years of laboratory experience associated with the testing performed in the QC Microbiology Technical Services Laboratory
Working Knowledge and/or experience in Terminal Sterilization Manufacturing and parametric release programs
Working Knowledge and/or experience in Equipment and Test Method Validation

QC Microbiology Assoc Resume Examples & Samples

Responsible for routine environmental monitoring, finished product, stability, and utilities sampling and testing
Must interpret and apply specifications and operating procedures when carrying out monitoring and testing responsibilities
Responsible for initial review verification of environmental monitoring, raw materials, and finished product data sheets
Responsible for ordering and maintaining materials, supplies, office inventory and data sheets a required
Review compiled batch records
Knowledge in project management
3 or more years lab experience in Pharmaceutical or Medical Device Industry
Working knowledge and/or experience in Aseptic Processing Manufacturing
Working knowledge and/or experience in Aseptic Processing Validation (Media Fills)
Working knowledge and/or experience with Isolator Technology

Director, QC Microbiology Resume Examples & Samples

Mentors Managers. Provides development plans and mentoring to members of the
Bachelor’s degree required, preferably in Chemistry, Microbiology, or related science
12 years’ relevant work experience required
5 years of leadership experience with direct reports required
An equivalent combination of education and experience may substitute
Advanced proficiency in MS Word, Outlook, and Excel
Advanced MS PowerPoint, Project, and Visio
Advanced knowledge of cGMP, OSHA, DEA, USP and EP
Requires flexibility and ability to multi-task
Advanced written and verbal communication skills
Advanced organizational and time management skills
Advanced critical reasoning and decision making skills
Advanced teamwork and facilitation skills
Ability to develop others, delegate and motivate
Requires strategic thinking and ability to work independently
Ability to interpret/write general, technical, and complex business documents
Requires strong qualitative training skills: responsiveness, enthusiasm, humor, sincerity, honesty, flexibility and tolerance
Advanced presentation development and delivery skills
Ability to solve routine and complex problems

Technician, QC Microbiology Resume Examples & Samples

Create/revise documents. i.e. SOPs and material specifications, investigations, protocols, and trend reports (water, environmental monitoring, or invalid assays)
Perform process environmental monitoring (EM) during aseptic cleanroom filling operations. This includes air sampling (viable and non-viable), surface sampling and personnel sampling. Must have experience in aseptic gowning and working RAB enclosures
Perform routine (EM) of fill rooms, ancillary room and compounding areas. Apply aseptic clean room practices during execution of all work tasks
Perform water sampling all utilities (water/gas) for both Mfg and QC labs
Perform General Microbiological Testing such as Bioburden, Endotoxin, sterile hold test, total plate count (TPC), Sterility testing, Coliform and biological indicator. Monitor and identify trends
Perform Microbial identification using Vitek II
Prepare and maintain microbial stock culture and perform Methods suitability (Bacteriostasis/Fungistasis (B&F)) testing
Routinely perform QC Microbiology inventory control
Assist in special projects (i.e. validations, microbiological studies, etc.)
Work 2nd Shift 3:00 PM – 11:00 PM and may have to come in early and stay late to support production, clean utilities, facilities and microbiology lab functions
Work weekends, overtime, and holidays, as needed

Manager, QC Microbiology Resume Examples & Samples

Supervision of sample receipt, retain storage and disposal
Management of QC Microbiology training program
SME on investigations of sterility and environmental excursions

QC Microbiology Supervisor Resume Examples & Samples

Co-ordination of area resources
Supervision of area personnel
Training of area personnel
Participate in corporate/regulatory audits
Delivery of area performance to meet or exceed performance or quality goals
Contribute to site management operational and strategic initiatives
Liaising with external vendors
Ensure compliance with cGMP and other business compliance regulations
Lead, promote, participate and supervise the implementation and maintenance of the EHS programmes relevant to you
Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up CAPA’s assigned to you
Monitor the EHS performance in your department
Participate and Comply with the MMD Quality Management System (QMS) requirements, including ownership, as relevant to you
Responsible for driving a culture of Continuous Improvement by deploying MSD Six Sigma tools
Develop an effective, focused and strong team by understanding: their abilities, unique contribution and broadening their skill set to be agile and prepared for any future business requirements. Provide your team with the tools and development opportunities (including educational assistance, job rotation, cross-functional training, Six Sigma) to make them successful
Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing, Quality, Engineering, etc)
At least 3 years’ experience in the Pharmaceutical industry or a similar operating environment which includes significant leadership roles with experience in a front-line supervisory role in operations environment
Knowledge of and experience in applying Six Sigma and Lean methodologies
Demonstrated leadership and change management skills with a continuous improvement focus
Degree or 3rd level qualification (Science/Quality/Technical). Masters preferred
Project Management qualification such as, Project Management Professional
Desirable evidence of Continuous Professional Development
Preference Lean Six Sigma Green Belt
Technical knowledge
Ability to respond to changing priorities

Senior Manager, QC Microbiology Resume Examples & Samples

Develop, revise and review SOPs, qualification/validation protocols and reports
Establish user requirements for purchase, qualification of Kite’s QC microbiological and equipment. Work with internal and external resources to maintain equipment in an optimal state
Create working schedule for EM and QC microbiology lab in advance
Revise and modify EM and PM SOPs per USA and EU guidelines
Assemble data and write reports on findings from environmental monitoring of Kite’s cGMP facility
Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures
Monitor the training records for the lab personnel. Make sure that % training completion rate is >90%
Conduct audit of internal testing labs and outside testing labs
Prepare monthly performance metrics by first week of every month
Interact with the QC Laboratory personnel to plan and schedule testing at scheduled time points
Perform other duties as assigned as on need basis

Technician, QC Microbiology Resume Examples & Samples

Collect water samples
Perform visual inspection of final product
Data entry and trend data
Routine maintenance of lab equipment and lab spaces

QC Microbiology Associate Resume Examples & Samples

Perform technical functions for the Quality Control Microbiology group in accordance with Agenus West policies and procedures
Perform testing of raw material, product release and stability samples in a timely manner
Maintain qualification requirements for the position to which they are assigned, and receive and stay current with training in cGMP’s, SOP’s, Company Policies and safety
Participate in the investigation and root cause analysis of microbiological quality issues in raw materials, in-process samples, finished products, utilities and facilities to help analyze and propose preventive and corrective actions
Review laboratory data in accordance with cGMP’s and good documentation practices
Requires a Bacherlor’s degree in a scientific discipline, or equivalent
Minimum 1-3 years of experience in a cGMP QC Microbiology function supporting a manufacturing environment
Demonstrated practical and theoretical knowledge of cGMP’s, USP, British Pharmacopoeia (BP), EP, JP, and regulations from FDA and the Medicines & Healthcare products Regulatory Agency (MHRA) as related to the manufacture of sterile pharmaceutical products is highly desirable

QC Microbiology Lab Technician Resume Examples & Samples

Water sampling Running to detect any potential bacteria
Running Bioburden, Endotoxin and sterility tests (insulator)
Realization of environmental controls in the QC
Reading and interpretation of environmental monitoring data generated in his various areas of Manufacturing
Monitoring of GLP such strategy 5S (office procedure range, ...)
Bachelor or equivalent experience
A first experience in a microbiology laboratory is an asset
Ready to work in shift

Senior Manager QC Microbiology Resume Examples & Samples

Monitor Environmental Monitoring and testing schedule, progress, data, and work quality
Assist MFG and Facility to solve microbiology related deviations/issues
Assist in creation, implementation, and administration of Microbiology based programs (training, gowning, etc.)
Experience with EMEA, ISO, FDA, and USP guidelines and regulations regarding Environmental Monitoring and Utility Systems (compressed gas, clean steam, WFI, HVAC)
Experience in environmental control and monitoring of clean rooms and utilities
Experience with data review, trending, and limit setting
Basic knowledge of sterilization science

Associate Analyst, QC Microbiology Resume Examples & Samples

Requires the ability to deal appropriately with regulatory agencies
Ability to multi-task and work flexible work schedule
Basic ability to interpret general business documents
Basic Problem solving skills
Ability to work cooperatively as an individual contributor and as a team member
Ability to gown and maintain a sterile work environment
Ability to work independently for extended periods of time
Basic proficiency in Microsoft Word, Outlook, and Excel
Basic knowledge of cGMP, OSHA, DEA, USP, and EP
Ability to pass an initial full physical with annual monitoring
Duties and Responsibilities
Aseptic gowning
Media fills
1 year of relevant work experience required, preferably in a regulated manufacturing environment with cGMP requirements
This position involves being fully gowned for extended periods of time within a restrictive movement environment. This may include standing, bending, reaching, kneeling, balancing, pushing, pulling, lifting (NMT 25lb), or carrying (NMT 25lb)
This may also include concentrating, remembering names, effective verbal and/or written communication, analytical thinking, decision making, and adapting to change
This position works within controlled environments with strict gown and gloves requirements
This position involves working conditions with constricted personnel movements for up to 6 hours a day
Definitions and Abbreviations
United States Pharmacopeia (USP)
European Union (EU)
Japanese Pharmacopeia (JP)
British Pharmacopeia (BP)
Occupational Safety and Health Administration (OSHA)
US Drug Enforcement Administration (DEA)
Personnel Protective Equipment (PPE)