Environmental Monitoring Resume Samples

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L Hudson

Lina

Hudson

9181 Kautzer Drives

New York

+1 (555) 618 6262

9181 Kautzer Drives

New York

Phone

p +1 (555) 618 6262

Experience Experience

Houston, TX

Environmental Monitoring Technician

Houston, TX

Reynolds LLC

Houston, TX

Environmental Monitoring Technician

Readily learns and applies new information and methods to work in assigned area
Develop monthly reports to communicate concerns, trends, and pending actions to Management
Perform any other tasks/duties as assigned by management
Perform wellfield valve/vacuum adjustments, data collection and maintenance; interpret data
Work typically involves regular review of output by work lead or supervisor
Monitor environmental performance against specifications within classified areas
Provide aseptic training and guidance to manufacturing, maintenance and R&D personnel

Boston, MA

QC Associate Lvl-environmental Monitoring

Boston, MA

Williamson Group

Boston, MA

QC Associate Lvl-environmental Monitoring

Problem solving of analytical methods as well as troubleshooting of equipment will also be performed as the employee advances from one level to the next
Eagerness to learn and perform additional assays/tasks in the lab
Quality of Work
Perform assay review when achieve assay competency with supervisor direction
Attendance and Punctuality
Routine environmental monitoring of air, surface, water, gas and steam systems
Complete GMP and Safety Training

present

New York, NY

Temporary QC Associate Lvl-environmental Monitoring

New York, NY

O'Kon, Volkman and Wiza

present

New York, NY

Temporary QC Associate Lvl-environmental Monitoring

present

Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage in activities that could result in compromising the quality of APIs
Problem solving of analytical methods as well as troubleshooting of equipment will also be performed as the
All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc)
Perform training on EM testing procedures/assays
Perform document changes
Perform general lab support
Perform routine testing with supervisor direction

Education Education

Bachelor’s Degree in Microbiology

Strayer University

Bachelor’s Degree in Microbiology

Skills Skills

18 years of age or greater
Ability to work independently in a fast-paced, team oriented organization
The ability to work both independently and as part of a team, following precise protocols
Excellent organisational and time-management skills
Strong analytical and numerical skills
Excellent written and verbal communication skills
Motivated, friendly and confident interacting with clients
Eligibility to work in the United Kingdom
Enjoy working outdoors
A full, clean driving licence

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Environmental Monitoring Program Analyst Resume Examples & Samples

6+ years of experience with Satellite Communications (SATCOM
Planning Programming Budgeting Execution (PPBE)/ABIDES Training Support Services (OCI Association)
Experience with Satellite Operations
Bachelors and nine (9) years or more experience; Masters and seven (7) years or more experience

QA Environmental Monitoring Associate Resume Examples & Samples

Perform surface, non-viable, viable air, settling plates in the transfer room and isolators
Perform gowning qualification of all MFG personnel upon exit from Transfer Suite
Label, track and continuously monitor viable air (SMA. Settling plates) in the isolators and transfer suite
Incubate and enumerate organisms on cultured media
Coordinate with manufacturing on scheduling of EM sampling
Responsible for media inventory. Ensure that the TSA and other related media use for environmental monitoring passed growth promotion testing prior to use
Ability to read, understand and follow SOPs
Ability to work in an aseptic environment
Monitoring of temperatures of incubators and refrigerators
Order laboratory supplies as needed
Ability to stand for a long period of time
Ability to lift 20 lbs
May perform other duties as assigned by Supervisor
A minimum of a high school diploma/AA with 2 years EM experience in a pharmaceutical/biotech industry; Bachelor’s degree in a scientific discipline highly preferred
Ability to follow directions, work on departmental projects and initiatives with minimal supervision
Strong verbal, written communication skills and computer skills are required
Proficiency using MS Word, Excel and PowerPoint. Excellent written, oral, communication and organizational skills

QA Environmental Monitoring Associate Resume Examples & Samples

Perform compressed gas and water sampling and testing
Track and Trend EM data including Microbial identification results in support for product release
Write/Revise EM SOPs
Provide input to technical reports
May perform other duties as assigned
A minimum of 4 years of EM experience in a pharmaceutical/biotech industry or a high school diploma/AA with 6 years EM experience in a pharmaceutical/biotech industry; Bachelor’s degree in a scientific discipline highly preferred
Ability to work independently on departmental projects and initiatives with minimum supervision

Supervisor Environmental Monitoring Resume Examples & Samples

Maintaining, managing and overseeing the Environmental Monitoring (EM) and Utility Monitoring (UM) program in Manufacturing, Hillerød
Follow up on excursions and deviations and initiate corrective and preventive actions
Support Validation and qualification activities related to EM and UM
Trending of EM and UM-data
Monitor current GMP trends in relevant areas and present program and data during internal and external audits and inspections
Support inspection of contract laboratories and filling sites
Support the Microbiology testing team
Coordinate and harmonize EM and UM methods and programs with other Biogen sites
Ensure that the staff in the EM team is managed and developed

QC Environmental Monitoring Resume Examples & Samples

60%: Supervision of daily and weekly activities of staff and
10-20%: Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
Repetitive bending and reaching to setup and break-down equipment (if required by

Cleanroom Environmental Monitoring Associate Resume Examples & Samples

Managing power outage, spill response, vermin control, and crisis support in the cleanrooms
Performing environmental monitoring activities in the cleanrooms such as air sampling and surface testing water and utilities for microbes and particulates and ensuring compliance with federal standards
Processing of change orders to update or create required documentation
Ability to collaborate on cross-functional teams and drive process improvement projects
Assessing and reviewing all new clean room materials and equipment prior to introduction to environment
Reviewing cleanroom custodial, environmental monitoring, and gowning paperwork for data integrity
Ensuring adequate system controls (policies, procedures, etc.) for clean-room compliance
Responsible for EM&C out-of- alert results documentation, including notification and re-testing of alert and action
Collecting samples for laboratory testing. All testing and results evaluation would be performed in accordance with written procedures
Assisting with lab maintenance activities required to support these testing service
Bachelor’s degree in Microbiology, Life sciences, or Technical Discipline (i.e. Engineering) OR a minimum of 5 years’ experience in Environmental Monitoring, Microbiology or a Laboratory environment
Computer skills (proficient at Word, Excel, PLM, etc)
Attention to detail and accuracy skills
Prior hands-on laboratory experience is a plus
Experience working in a cleanroom environment and using portable hand-held particle counters, and other EM equipment

Environmental Monitoring Technician Resume Examples & Samples

Perform environmental monitoring (non-viable particulates, air viables, surface, temperatures) in cleanroom environments within the Manufacturing area
Perform environmental monitoring for aseptic filling processes
Operate monitoring equipment that includes Met One Laser Particle Counter, Biotest RCS Viable Air Sampler, Conductivity meter, pH meter, TOC analyzer
Monitor temperatures of Manufacturing and Microbiological QC temperature storage units
Perform Preventative Maintenance verification of RCS Air Sampler
Read EM plates/strips and document results on relevant forms
Collect Purified Water samples throughout the manufacturing facility and perform TOC and conductivity testing of samples
Input trending data for EM and water samples
Perform Cleaning Verification of cleaned production equipment
Perform Area Release per protocol for campaigned manufacturing areas
Responsible for notification and re-testing of alert and action OOL's

Environmental Monitoring Expert Resume Examples & Samples

Provide support and expertise to the operations to improve manufacturing aseptic processes (such aseptic practices, environmental monitoring, cleaning and sanitization, Sterilization,…) to deliver products with the highest sterility assurance level
Collaborate Manufacturing, QC and QA departments to maintain and improve a routine environmental monitoring program
Manage GMP documentation such as SOPs, protocols or reports related to environmental monitoring
Write and review analytical data and scientific reports
Participate actively in investigation and aseptic processes improvement. As an expert, he/she will be the leader for investigations of deviations related to environmental issues
Follow-up deviations, CAPA plans and change controls related to environmental monitoring
Participate to customer and authorities audits
Bachelor or Master level in a scientific discipline (Bio Engineering, Biology, Biotechnology, Biochemistry, Pharmacy)
Minimum 3-5 years’ experience working in the pharmaceutical industry. An experience in aseptic production is an asset
Good knowledge of GMP regulations (US and Eur)
Good knowledge of microbiological analytical techniques and
Quality oriented, rigorous and well organized
Knowledge of French and English (oral and written)

Senior Quality Assurance Environmental Monitoring Associate Resume Examples & Samples

Perform a wide variety of quality assurance activities to ensure compliance with Company procedures
Track and review of EM test records
Track and investigate EM excursions and associated deviations
Perform line clearance and product inspection
Review data entries for EM Quarterly Trend reports
Track and prepare Monthly EM Excursion Reports
Review documents such as standard operating procedures, logbooks, and temperature charts
Act as a compliance resource to provide guidance and assistance towards resolution of moderate deviations, quality investigations, excursion investigations, CAPAs and change controls
Support continuous improvement of quality operations processes by authoring new or revise existing department procedures and/or forms
Assist in internal compliance audits as needed
Provide inspection readiness support and assist during inspections by regulatory authorities
May support quality systems as needed (e.g., issue and track closure to change controls, deviations, quality investigations and CAPAs)
Minimum of 8 years of experience in the pharmaceutical or biotechnology industry with at least 6 of those years in QA or closely related field
Good working knowledge of 21 CFR Parts 201, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents
Good interpersonal and verbal and written communication skills
Good working knowledge and understanding of US and international (e.g. EU, ICH) cGMP regulations, procedures and guidelines that govern manufacturing, quality control and quality assurance of drugs/device
Attention to detail with an ability to perform critical review of various types of technical documents
Proficient with commonly used word processing, database systems and other software

Environmental Monitoring Technician Resume Examples & Samples

Clean room particle counts every 90 days
Audit the production and aseptic processes
Certified Pharmacy Technician

QC Supervisor, Environmental Monitoring Resume Examples & Samples

Scheduling and Planning of EM testing. Ensures equipment and the work area is safe for employees to perform their duties
Assay/Documentation/Quality System Writing/Review
Attending department related meetings
Independently drive or oversee projects to on-time completion
Resolving personnel issues and work place conflicts
Troubleshooting, problem solving operational and or performance issues
Other – such as leading OE initiatives, Improvements, Helping with Transfers, hiring of staff
Bachelor degree and/or Advanced Graduate degree (MS/PhD)
Preferred area of study: Microbiology, Biochemistry or equivalent Science Field
Preferred 2-5+ years in a GMP/Professional environment
Ideally 2+ years direct supervisory experience
Use of Microsoft Suites (Word, Excel, Powerpoint)
Use of Laboratory computer systems (MODA)
Potential previous use of GMP Quality Systems such as: TrackWise, LIMS
Strong planning, prioritization, and scheduling skills
Strong ability to speak publicly. Displays a calm and controlled demeanor in all situations
Strong ability to interpret data and troubleshoot testing in area of expertise
Perform assigned, complex and/or varied tasks
Excellent ability to problem solve. Changes work within their group quickly in unexpected situations
Outstanding ability to collaborate testing with Manufacturing
Clearly outlines and gives instructions to analysts in their team
Direct and plan tasks/projects
Excellent ability to communicate in both written and verbal format. Is able to clearly communicate via email or memo as required

Improvement Engineer Biotech DSP Environmental Monitoring Resume Examples & Samples

Support and manage the routine Environmental Monitoring (EM) activities in our cleanrooms and (Clean) Utility Monitoring (UM) programs on a daily basis
Coordinate and resolve Quality Notifications (events) related to EM and UM excursions
Define and implement corrective and preventive actions
Execute improvements in business processes, leveraging lean six sigma and/or Kata mind-set
Direct oversight on EM technicians and responsible for development of the EM group
Trending of EM and UM data including annual reporting
Represent the IPT during internal-, client- and external audits and inspections for EM and UM related matters
Closely interact with and support manufacturing and quality personnel in all aspects of EM observations, process improvements and investigations
Maintain current knowledge of regulatory and industry standards, trends and advancements in EM and UM
Bachelor’s or Master’s degree in Microbiology, Biotechnology, Biochemistry, Engineering or equivalent
Experience in Root Cause Analysis and facilitate Lean Six Sigma tools
Thorough understanding of cGMP, Regulatory expectations, and international industry guidelines
Must be proactive, results oriented, and have a strong attention for detail
Project Management skills (preferably)
Strong people and communication skills to communicate with all layers of the organization

Improvement Engineer Biotech USP Environmental Monitoring Resume Examples & Samples

Supports and manages the routine Environmental Monitoring (EM) activities in our cleanrooms and (Clean) Utility Monitoring (UM) programs on a daily basis
Coordinates and resolve Quality Notifications (events) related to EM and UM excursions
Defines and implements corrective and preventive actions
Executes improvements in business processes, leveraging lean six sigma and/or Kata mind-set
Directs oversight on EM technicians and responsible for development of the EM group
Trends EM and UM data including annual reporting
Represents the IPT during internal, client and external audits and inspections for EM and UM related matters
Closely interacts with and support manufacturing and quality personnel in all aspects of EM observations, process improvements and investigations
Develops and maintains site policies and procedures related to EM and UM ensuring compliance to corporate and regulatory standards
Maintains current knowledge of regulatory and industry standards, trends and advancements in EM and UM
At least 3 years of experience in aseptic or sterile processing in cleanrooms with high focus on microbiology (highly preferable)
Thorough understanding of cGMP, regulatory expectations, and international industry guidelines
Engage and coach team to solve problems, continuously developing problem solving skills
Analytical and organizational mindset
Excellent verbal and written communication skills in both Dutch and English language

Senior Manager QC Environmental Monitoring Resume Examples & Samples

Strong knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as related to manufacture of sterile pharmaceutical products
Strong data integrity knowledge and practices
Strong understanding and demonstrated use of statistics, control charts, action and alerts related to environmental monitoring,
Must have experience in supporting sterile compounding and filling operations
Demonstrated knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc
Demonstrated expertise in Media Fills or Process Simulations
Strong knowledge of Good Engineering Practices and Validation Principals: URS, IQ, OQ, PQ, PVs, etc
Experience in participating and supporting regulatory audits: FDA, MHRA, PMDA, etc
Ability to manage and practice continuous optimization of the site EM Monitoring, Aseptic Technique training, and Gown qualification programs
Strong experience in working with Quality Systems: SOPs, Change Control, Deviations, CAPAs, and Risk Assessments
Requires excellent verbal and written communication skills. Ability to collaborate with outside department to drive operational and quality excellence
Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision-making skills
Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team based environment
Lead the department to ensure that site and department objectives are met
Ensure employees are properly trained and qualified to perform assigned tasks, provide performance evaluations and support career development of direct reports
Demonstrated mentoring and coaching, influencing, negotiating and personal interaction skills
Demonstrated resource management and planning skills. Must be flexible and adaptable, and able to work under pressure, while meeting designated time lines
Demonstrated ability to develop, manage, and forecast budgets
Knowledge of safety, OSHA, and EPA regulations. Electrical and energized equipment (lockout/tag out), fall safety, HAZCOM, MSDS sheets, etc
Proficiency with the use of Microsoft Word, Outlook, Excel, PowerPoint, etc
Requires a Bachelor’s degree in Microbiology or related science from an accredited college or university. An advanced degree, training or qualifications is a plus
A minimum of 9 years’ experience working in the Environmental Monitoring area and/or Microbiology laboratory in an aseptic sterile manufacturing facility is required. Strong Environmental Monitoring management experience in a sterile manufacturing site is required
3+ years of progressive management experience
Strong knowledge of FDA, MHRA, PMDA, etc. aseptic manufacturing regulations and guidelines
Minimum of 9 years working in an aseptic manufacturing environment

Environmental Monitoring Advisor Resume Examples & Samples

Experience of Civil Engineering or Construction and large multidisciplinary projects preferred
Experience of driving and assessing sustainability
The ability to positively influence others
Ability to multi-task and work under pressure
Excellent verbal and written communication skills, including public speaking

Temporary QC Associate Lvl-environmental Monitoring Resume Examples & Samples

Analysis of environmental samples according to Standard Operating Procedures and Test Methods
Routine environmental monitoring of air, surface, water, gas and steam systems
Documentation of results in accordance with current Good Manufacturing Practices (cGMP)
General lab support including housekeeping, equipment maintenance, inventory of supplies, etc
Complete GMP and Safety Training
Problem solving of analytical methods as well as troubleshooting of equipment will also be performed as the
Perform routine testing with supervisor direction
Perform general lab support
Perform assay review when achieve assay competency with supervisor direction
All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc)
Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage in activities that could result in compromising the quality of APIs

Environmental Monitoring Technician nd Shift Resume Examples & Samples

Daily Viable particle counts of laminar flow hoods
Daily contact surface testing
Weekly Viable particle counts of room
Quarterly classified contact surface testing

Environmental Monitoring Technician Resume Examples & Samples

Attend and investigate water pollution incidents across a designated area
Gather environmental field data and report writing in response to the pollution incidents
Conduct benthic macro-invertebrate surveys and bankside identification
Rrecommend remediation and mitigation measures to the client as appropriate
Complete a planned programme of environmental data gathering
Calibrate and maintain specialist water quality equipment
Work in the best interest of the Company with honesty and good faith towards all communities within which the Company operates
Uphold and protect the good name and reputation of OHES Ltd and Arthur J. Gallagher Limited at all times and ensure they act with integrity, act with due skill , care and diligence and observe proper standards of conduct
Carry out duties in accordance with internal policies and procedures, applicable laws, rules, regulations, good governance and Gallagher’s shared values, in particular, putting clients at the heart of our business
Degree level in a Biological or Environmental Sciences discipline is essential
An understanding of water chemistry and the indicative parameters
Aquatic macro-invertebrate identification skills to Family level (eg. BMWP)
An awareness of EIA methodology
GIS skills
An understanding of the role of environmental legislation and regulation
An understanding of the UK Water Industry
Proven experience of scientific field work, bethnic macro-invertebrate and fishery surveys
Competant in Microsoft Outlook, Excel and Word
Team Players, willingness to learn, acquire new skills and develop
The ability to work both independently and as part of a team, following precise protocols
Excellent organisational and time-management skills
Strong analytical and numerical skills
Motivated, friendly and confident interacting with clients

Environmental Monitoring Laboratory Principal Scientist Resume Examples & Samples

Influencing staff without direct line responsibility
Ability to prioritise resources using Continuous Improvement principles
Ability to effectively contribute to department project activities
Experience of training & coaching e.g. in analytical techniques, instrumentation troubleshooting
Strong understanding of analytical techniques, instrument troubleshooting and cGLP and computer systems such as Empower, M-ERP, Excel, Word, Statistica, CARISMA etc
Knowledge of Quality Management Systems, Environmental Health & Safety and Operational Excellence
Acts as delegate for Laboratory Team Leader for directing laboratory workload/activities when required (e.g. out of hours, holidays etc.)
Acts as delegate for Laboratory Team Leader in Laboratory Investigation Process to ensure that LIRs are reviewed and progressed as per GSK QMS and local SOP when required (e.g. out of hours, holidays, etc.)
Owner of key governance processes such as penicillin and microbiological environmental monitoring, trending and reporting ensuring they are completed on time and in compliance with documented procedures
Ensure adherence with operator standard work, trending all deviations using GPS metrics
Checking of laboratory data and review of laboratory documentation to support batch release process, and drive Right First Time improvements
Lead laboratory investigations ensuring that Root Cause Analysis is completed as required and appropriate corrective and preventive action (CAPA) is developed
Driving laboratory continuous improvement activities by coaching and training in Data Integrity, Root Cause Analysis, Human Factors and CAPA, laboratory investigation report writing, analytical techniques and laboratory instrumentation troubleshooting to ensure competency including GMP (GcLP)
Support Infrequent Task Process, ensuring that proper action is taken by Laboratory Scientists before any non-routine task is carried out to drive appropriate safety and compliance behaviours
Carry out compliance activities such as Gemba, L1 Self Inspections and act as a subject matter expert during internal and external regulatory and customer audits
Lead and implement improvement activities using Change Control
Play an important role in delivering our mission
Be an essential part of diverse, global team
Develop others as part of your own professional growth

Environmental Monitoring Technician Resume Examples & Samples

1) Ability to work independently, ability to work well within a team, and willing to work overtime as needed to meet demands of Center
2) Must have demonstrated strength in written and verbal communication, organization skills, and detailed orientation
3) Computer related skills (word processing, spreadsheets) are required
4) Certified Pharmacy Technician is a plus but not required

Environmental Monitoring Technician Resume Examples & Samples

Applies acquired knowledge and skills to complete standard tasks
Readily learns and applies new information and methods to work in assigned area
Maintains appropriate licenses, training and certifications
Works on routine assignments that require some problem resolution
Works within clearly defined standard operating procedures and/or scientific methods
Adheres to all quality guidelines
Works under moderate degree of supervision
Work typically involves regular review of output by work lead or supervisor
Refers complex unusual problems to supervisor
Conduct environmental monitoring activities including air, surface and personnel inside the sterile manufacturing areas
Must complete and maintain gowning certification to work in clean room and also help gown train other employees
Conduct water sampling throughout facility
Record results and report deviation from specifications
Communicate any discrepancies or deviations to supervision/management upon discovery
Ensure all work is performed and documented in accordance with existing company policies, procedures, Current Good Manufacturing Practices, and health and safety requirements
Inputs data into database and conduct trend analysis
Perform any other tasks/duties as assigned by management
Plan daily workload to meet requirements
High School Diploma or GED required; coursework in Microbiology/Biology preferred
Prior experience in manufacturing, preferably in a controlled environment and/or regulated industry
Working knowledge of MS-Office software and PC Skills Required
Ability to work in a team oriented environment
Organization and attention to detail
Ability to hear, write, read (English), and speak (English) clearly in order to communicate in manufacturing setting - required
Able to repeatedly follow detailed processing instructions
Ability to manage several tasks at the same time; Ability to evaluate operating conditions and exercise sound judgment and problem solving skills
Lifting: Frequent lifting between 25-50 lbs
Ability to see fine particulate and differentiate colors in liquid solutions
Manual dexterity required for equipment operation and occasional reach and lifting of small objects
Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees

Environmental Monitoring Technician Resume Examples & Samples

Perform environmental monitoring (EM) according to internal SOP and policy
Be knowledgeable on EM lab equipment and techniques (SAS, MAS, Climet particle counter, viable airborne monitoring (active and passive), total airborne particulate sampling, viable surface monitoring, and personnel monitoring)
Ensure that all necessary training is carried out to perform assigned tasks both confidently and consistently
Ensure the use of proper aseptic technique during execution of EM related tasks
Collaborate with other team members to ensure that assigned tasks are performed in timely and accurate manner
Update microbiological EM database and prepare - reports as requested. Perform maintenance of EM database as well as EM trending
Assist with EM investigations
Assist in calibrating and maintaining lab equipment
Maintains laboratory supplies, media, and reagents inventory
Take on responsibility of plate incubations and be able to perform plate enumeration to attain final viable EM results
Review data for accuracy and compliance to specifications, reporting errors to supervisor
Receive, quarantine, and test supplies and raw materials for QC testing, including testing of commercially prepared microbiological culture media
Aid in revision and updates of standard operating procedures as needed
Aid in training and certification of aseptic gowning of fellow employees
Must demonstrate flexibility in adjusting to changing priorities and schedules
Perform routine Quality Control testing of in-process and final products in a cGMP lab for release
Perform other general duties associated with the position as required by supervision. Apply knowledge of cGMP on a daily basis
May perform additional duties as required
Superior attention to detail, this includes the ability to meticulously organize and maintain data and information
Ability to learn through observation and hands on experience
Knowledge of cGMP a plus
Experience in clean room environmental monitoring and aseptic technique a plus
Outstanding oral and written communication skills
Ability to work independently in a fast-paced, team oriented organization

Environmental Monitoring Team Lead Resume Examples & Samples

Act as a liaison between the EMPS team and Manufacturing
Coordinate EM sampling to support Manufacturing needs
Provide training for Environmental Monitors and backup environmental monitoring functions as necessary
Audit aseptic technique, practices, and behavior for personnel working in the aseptic areas
Provide aseptic technique and behavior training to new hires and coaching to individuals as needed
Support trouble shooting for environmental excursions and aseptic breaches and make decisions on remediation actions and when manufacturing can resume
Support NC and RC/CAPA investigations and reviews
This position is for 2nd and 3rd shift roles. 2nd shift runs in the 3PM-11PM range.. 3rd shift runs from 11 PM-7AM range

Supervisor Microbiology Environmental Monitoring & Utilities Resume Examples & Samples

Lead the QC Micro EM and Utility team to manage the day to day business and meet the agreed annual business plan
Coordination of activities of QC Micro EM and Utility specialists and sampling stewards in order to ensure sampling and analyzing of samples in compliance with quality standards
CGMP compliant function and control of media loops (water, clean steam, pressed air, gases)
CGMP compliant control of production environment in all production areas at Janssen Schaffhausen
Data trending and escalation of trends
Microbiological support of production department and Technical Operations regarding EM and Utility monitoring
Leading risk assessments in multidisciplinary teams
Process optimization projects for EM and Utilities as Subject matter Expert for microbiological monitoring
Author of protocols and reports in own area of responsibility
Drive continuous improvement within Microbiology Environmental Monitoring & Utilities
Participation in site specific and global standardization and improvement projects as a subject matter expert
Handling of Change Controls/CAPA’s and Deviations
Active participation in internal inspections as subject matter expert
Maintain excellent partnership with all business partners

Environmental Monitoring Technicians Resume Examples & Samples

Sample Receipt, Incubation and Enumeration of microbiological environmental samples from aseptic areas, personnel and utility systems
Perform USP Water testing of pharmaceutical water systems including Bioburden, Endotoxin, Total Organic Carbon (TOC), Nitrates, pH and Conductivity
Provide data entry and review as required
Provide summaries of test results to appropriate personnel as needed
Perform growth promotion testing of media and agars
Participate in media challenge execution and evaluation of units
Perform method qualification testing
Troubleshoot applicable lab equipment as needed
Participate in resolving laboratory and production investigations as needed
SOP development and review
Direct support of regulatory inspections and audits
Direct support of validation activities and all other associated quality functions

QC Associate Lvl-environmental Monitoring Resume Examples & Samples

Duties and Responsibilities include but are not limited to
This role requires an initial training period on dayshift for approximately one month. Employee will transition into a permanently night shift role once training is complete
Analysis of environmental samples according to Standard Operating Procedures and Test Methods
Routine environmental monitoring of air, surface, water, gas and steam systems
Documentation of results in accordance with current Good Manufacturing Practices (cGMP)
General lab support including housekeeping, equipment maintenance, inventory of supplies, etc
Complete GMP and Safety Training
Problem solving of analytical methods as well as troubleshooting of equipment will also be performed as the employee advances from one level to the next
Perform routine testing with supervisor direction
Perform general lab support
Perform assay review when achieve assay competency with supervisor direction
Attendance and Punctuality
Quality of Work
Ability to interface with members of Quality and other departments in a professional manner
Eagerness to learn and perform additional assays/tasks in the lab
Perform training on EM testing procedures/assays
Initiation, review and closure of Deviations
Perform document changes
Quality should be the responsibility of all persons involved in Manufacturing. Adherence to cGMPs is required at all times during the manufacture of APIs
All personnel should practice good sanitation and health habits

Environmental Monitoring Technician st Shift Resume Examples & Samples

Monthly floor contact surface testing
Coordinate with Quality Manager on environmental issues
Perform additional duties as required and assigned by the Quality Manager
Ability to work independently, ability to work well within a team, and willing to work overtime as needed to meet demands of Center

Environmental Monitoring Technician Resume Examples & Samples

Weekly, Monthly, Quarterly APR, MPR, and Tubes Environmental Monitoring (Cleanroom batch related sampling is performed by Production)
Weekly APR Pre and Post Cleaning Environmental Monitoring
Maintaining stock of media required for routine environmental monitoring program
Reading and reporting of all Environmental Monitoring and Water Testing plates
Gram stains, subcultures, and Vitek identifications to support Environmental Monitoring and Water testing
Generating EM investigation reports for out of limit results
Data Entry of all Environmental Monitoring results
Data entry for PIDs in the WIV database
Filing of EM worksheets and PIDs
Executing EM Qualification of new manufacturing areas
Setting of Environmental Monitoring Limits
Trainer for Gowning (testing, documentation, and results)
Assists in maintaining standards in accordance with GMP's/SOP's and ISO regulations
Sample finished products in accordance to the AQL for specialized products
Evaluate effectiveness of 100% inspection process through random AQL sampling of completed inspections
Complete MLA testing of products
Perform Quanti-Cult testing
Support all company policies
Possess at least a high school education. A 4 year degree in the sciences or Course work in microbiology is a plus
Possess a minimum combined 2 – 5 years of experience in Quality Assurance, production work, or an equivalent combination of education and experience
Familiarity with FDA regulations for medical devices
Possess the ability to manage many tasks and in an organized fashion
Possess the ability to work in a fast paced environment
Possess intermediate computer skills, preferably with experience in Word, Excel, Access, and LIMS programs
Listen to, and follow, written and verbal instructions in English

Environmental Monitoring Support Specialist Resume Examples & Samples

Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site
Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions
Knowledge of aseptic technique, contamination control, cleanroom behavior and GMP/ISO
Knowledge of/ability to learn microbiological methods, microbial identification systems and use of equipment
Ability to gown aseptically
Ability to understand the importance of compliance with Good Manufacturing Practices and ISO requirements
Must be able to competently demonstrate aseptic technique
Good listener, positive, trainer

Environmental Monitoring Resume Examples & Samples

Maintaining and ensuring the environmental quality of cleanrooms
Ensuring gowning and de-gowning training and procedures are adequate and reflect current requirements
Assisting with cleanroom move assessments and validations as necessary
Assessing and reviewing all new cleanroom materials and equipment prior to introduction to environment
Trending the results of environmental monitoring and initiating responses as necessary and stay organized
Partnering with cleanroom custodial team for scheduling of cleaning events and ensuring training is completed
Maintaining responsibility for EM&C out-of-alert results documentation, including notification and re-testing of alert and action level excursions
Performing and documenting Limulus Amebocyte Lysate (LAL) sampling on water systems and viable bacteria sampling on water/air/surface samples (all testing and results evaluation would be performed in accordance with written procedures)
Assisting with lab maintenance activities required to support these testing services
Bachelor's Degree and one year related work experience OR college coursework in biology, microbiology or related discipline and 2 years of related work experience in cleanroom testing or lab sampling
Experience working within a Quality system
Effective communication skills, both written and verbal
Attention to detail and accuracy, including ability to take precise and accurate measurements
Prioritizing and multitasking skills
Troubleshooting skills
Ability to work effectively in team situations as well as independently
Effective decision-making skills
Prior hands-on laboratory experience
Knowledgeable with Environmental Standards (ISO 14644-1, ISO 14644-2, ISO 11737-1, etc.)
Knowledgeable with cGMPs, ISO 13485, USP, Good Documentation Practices
Experience working a cleanroom environment and using portable hand-held particle counters, and other EM equipment

Environmental Monitoring Associate Resume Examples & Samples

Ensure Environmental Monitoring (EM) of the facility’s controlled areas is performed as required
Document EM testing into the EM database prior to incubation, ensure samples are correctly incubated, and record sample results in the EM database following incubation
Compile trending data for EM testing to support investigations
Author laboratory event reports
Communicate issues between departments as appropriate
Communicate effectively with co-workers to ensure all required tasks are completed as expected
Document test data clearly and accurately. Maintain data integrity and ensure compliance with company policies, procedures, cGMPs, and regulatory requirements
BS/BA Degree in Microbiology or Biology with 0-2 years pharmaceutical microbiology experience. Microbiology coursework and laboratory work utilizing aseptic technique is required
Must be able to pass and maintain Class 100/ISO 5/Grade A gowning qualification
Must have the ability to handle multiple tasks concurrently and complete tasks in a timely fashion
Must be able to communicate effectively across all departments and levels of management
Must have understanding of laboratory instruments and methods
Must have excellent writing skills to write clear and concise reports
Knowledge of pharmaceutical microbiological methods and cGMPS as well as an understanding of scientific principles preferred

Raw Materials & Environmental Monitoring Assistant Resume Examples & Samples

Ability to work in a fast paced environment with a positive attitude
Ability to carry out assignments in a thorough, conscientious fashion
Ability to follow detailed instructions, maintain accurate records and notes
Ability to work well in a team environment
Knowledge of basic computer applications and ability to use MS Office software
Conscious of biological safety requirements and applicable material handling methods

Environmental Monitoring Technician Resume Examples & Samples

Perform investigations into environmental excursions
Actively participates in the Tier process and uses this forum to escalate concerns and best practices
Adherence to SOPs, GMPs and safety procedures. Author environmental project protocols and reports

Quality Specialist, Environmental Monitoring Resume Examples & Samples

Becomes fully trained in Quality SOPs, production SOPs as needed, and SAP functions as required by EM Quality Specialists
Learns cGMPs, the manufacturing process, and quality systems
Monitor environmental performance against specifications within classified areas
Provide environmental support to manufacturing and testing areas as needed
Performs Quality review/approval of new and updated SOPs and Controlled Job Aids. Ensures compliance with departmental procedures
Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans
Adherence to SOPs, GMPs and safety procedures
Aid in investigations into environmental excursions
Author environmental project protocols and reports
Assists with training of incoming personnel
Cross trains to support other functional quality areas including but not limited to deviation management, environmental monitoring investigations, and inspection support
A minimum of two (2) years of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations
Evidence of good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills
Attention to detail, flexibility and an awareness of production and attendant quality control problems
Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields
Familiarity with vaccine and/or pharmaceutical processing
Aseptic gowning may be required

Environmental Monitoring Technician, Nights Resume Examples & Samples

Complete all necessary documentation
Develop monthly reports to communicate concerns, trends, and pending actions to Management
Previous experience with environmental monitoring, asceptic technique and microbiology/biology background is preferred
Must have demonstrated strength in written and verbal communication, organization skills, and detailed orientation

Environmental Monitoring Technician Resume Examples & Samples

Conduct viable and non-viable environmental monitoring throughout the facility (air and surfaces)
Properly incubate and examine samples for microbial growth and enumerate bacteria
Transfer results of monitoring into Microbiology Information Management System (MIMS)
Provide aseptic training and guidance to manufacturing, maintenance and R&D personnel
Participate in and/or conduct investigations into cases of microbial growth (excursions)
Physically active responsibilities include lifting, gowning, walking between manufacturing suites and the laboratory, and bending
Bachelors degree in Biology or Microbiology or Associate’s Degree with 2+ years relevant manufacturing quality assurance or quality control experience
Ability to work in a controlled environment with gowning/PPE requirements
Computer literacy including Microsoft Office Suite (e.g., Word, Excel, Outlook)
Basic technical writing ability and strong attention to detail
Demonstrated ability to work well in a team environment

Environmental Monitoring Technician Resume Examples & Samples

Properly operate and maintain GCCS in a timely and cost effective manner to ensure regulatory compliance and optimize performance
GCCS operation and maintenance includes
Calibrate, operate and maintain sensitive electronic data collection devices necessary to optimize LFG collection from the wellfield
Collect and manage data entry from wellfield extraction and environmental monitoring locations
Implement the GCCS preventative maintenance plan
Operate and maintain liquid management system pneumatic or electric driven pumps (troubleshoot and determine liquid levels within liquid containment structures and or LFG collection wells)
Perform wellfield valve/vacuum adjustments, data collection and maintenance; interpret data
Use Polyvinyl Chloride (PVC) or High Density Polyethylene (HDPE) piping materials and associated equipment to perform maintenance on piping materials
Complete the WM Landfill Gas Technician I Training
Develop basic understanding of environmental regulations related to GCCS operations and develop the ability to work within an environmentally regulated industry
Follow job related health and safety requirements and procedures
Available for on-call response to GCCS related malfunction event(s)
Education: Not required
Experience: No prior work experience required
18 years of age or greater
Required to use motor coordination with finger dexterity (such as keyboarding, monitoring device use, machine operation, etc.) most of the workday
Required to exert physical effort in handling objects up to __ pounds: on occasion
Required to work outdoors approximately 80% of each workday, work involves exposure to dirt, odors, noise, weather extremes, or similar elements
Required to walk over steep and rough terrain for considerable distances on a daily basis
Required to wear personal protective equipment (safety glasses, hardhat, safety boots, safety vest, personal multi-gas monitor, etc.) in accordance with company Health and Safety standards

Chief, Environmental Monitoring Resume Examples & Samples

Thorough knowledge of the principles and techniques of theoretical and applied chemistry, biochemistry, microbiology, waste management, operation of analytical instrumentation and sanitary engineering
Extensive knowledge of pertinent federal, state and county procedures and regulations and the ability to ensure compliance
Knowledge of wastewater treatment plant design and construction as well as operating principles
Ability to manage and direct highly technical and scientific staff
Ability to readily discuss a spectrum of environmental issues at any time
Ability to recognize the need for new or revised test methods or equipment
Ability to communicate effectively both verbally and in writing
Ability to evaluate and compose financial and administrative documents
Ability to compose detailed scientific reports
Ability to prepare operating and or capital budgets