Environmental Monitoring Resume Sample
Jermain Dickens
5111 Friesen Parkway,
Chicago,
IL
+1 (555) 650 6916
Work Experience
Senior Manager QC Environmental Monitoring
09/2015
-
PRESENT
Dallas, TX
- Perform thorough investigations related to Microbiology Department functions
- Fill out cleanroom information sheets
- Label all cleanroom plates for production runs
- Record the exposure time on the plates and also on the cleanroom information sheet
- Plate all personnel on their exits from filling
- Perform required sampling utilizing contact plates, settling plates, RCS strips, and swabs
- Perform environmental monitoring testing on scheduled days
- Log in all plates in proper logbooks in the Microbiology Laboratory
- File environmental control sheets in proper folder
Environmental Monitoring Technician
05/2011
-
04/2015
Phoenix, AZ
- Performs environmental monitoring of ISO class 5 thru 8 cleanrooms using viable air samplers and non-viable particle counters
- Collects, analyzes and interprets microbiological testing data
- Perform routine data entry and data trend analysis
- Helps prepare trend reports for management review
- Collects, analyzes and trends facility water to include WFI and RODI ports
- Maintain adequate inventory of supplies needed for all microbiological testing including but not limited to pipets, reagents, glassware, and consumables
- Assists in everyday organization of Microbiology laboratory including cleaning, maintenance and ordering of supplies
- Perform area cleaning and waste removal, as needed
Raw Materials & Environmental Monitoring Assistant
02/2004
-
11/2010
Boston, MA
- Update sample information in laboratory databases
- Particle Measuring System review and interface
- Validation protocol testing for new areas and facilities
- Ensure Environmental Monitoring (EM) of the facility’s controlled areas is performed as required
- Fill out clean room information sheets
- Label all clean room plates for production runs
- Record the exposure time on the plates and also on the clean room information sheet
- Assist in performance of thorough investigations related to Microbiology Department functions
- Function as primary shift technician for environmental monitoring
Education
Arizona State University
2000 - 2004
Bachelor's Degree in Microbiology
Professional Skills
- Intermediate skills in applicable computer programs
- Essential and Critical Skills
- Understanding of GLPs and GMPs. Experience with aseptic technique
- Experience prolonged standing, some bending, stooping, and stretching
- Experience collecting environmental samples in drug or medical device manufacturing area
- Environmental monitoring experience is required, preferably in a GMP environment
- At least one year of work experience in a laboratory setting
How to write Environmental Monitoring Resume
Environmental Monitoring role is responsible for training, computer, reporting, database, auditing, shipping, manufacturing, research, events, government.
To write great resume for environmental monitoring job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Environmental Monitoring Resume
The section contact information is important in your environmental monitoring resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Environmental Monitoring Resume
The section work experience is an essential part of your environmental monitoring resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous environmental monitoring responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular environmental monitoring position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Environmental Monitoring resume experience can include:
- Operate EM equipment such as Particle Counter, Microbial Air Sampler and verify that the equipment is within calibration prior to use
- Assist with executing validation protocols for processes and/or equipment
- Manufacturing or quality control experience in a pharmaceutical environment
- Practical experience in environmental monitoring and/or Utilities
- Experience in aseptic manufacturing areas
- Follows quality system and Good Laboratories Practices (GLP) compliance and revises SOPs related to Microbiology, Environmental Control, and Sterilization
Education on an Environmental Monitoring Resume
Make sure to make education a priority on your environmental monitoring resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your environmental monitoring experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Environmental Monitoring Resume
When listing skills on your environmental monitoring resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical environmental monitoring skills:
- Possess good documentation and computer skills
- Direct experience in a laboratory setting
- Maintain equipment and tools in good working order and report any problems to supervisor
- Assess and reviewing all new cleanroom materials and equipment prior to introduction to environment
- Experience in aseptic or sterile processing in cleanrooms with high focus on microbiology (highly preferable)
- Experience in a cGMP pharmaceutical manufacturing environment
List of Typical Experience For an Environmental Monitoring Resume
1
Experience For Environmental Monitoring Technician Resume
- Excellent organization, detail-oriented and accurate
- Operate production equipment without supervision after certification
- When required at the project site, immediately notify lead technician of high priority emitting/leaking components. Provide details to assist repairs
- Establish, validate and implement new microbiology methods
- Set-Up, Validate and oversee the implementation of new equipment
- Perform Personnel Monitoring on manufacturing colleagues working inside the grade A and B classified manufacturing areas
2
Experience For Senior Manager QC Environmental Monitoring Resume
- Complete duty-based packets by reading SOPs (Standard Operating Procedures) and excerpts from technical documentation. Complete all required training
- Write summary reports summarizing personnel and environmental monitoring results highlighting any trends observed
- Ensure proper documentation practices during production including batch record and log entries as required
- Collection and testing of qualified Utility systems including Clean Steam, WFI and compressed gases
- Perform first repair attempt (minor adjustment) on approved leaking components per Summit Inspection’s Standard Operating Procedures
- Communicate ideas for improving operations surrounding the project to the supervisor
- Ability withstand prolong walking and standing and work on elevated surfaces
- Perform Environmental Monitoring within the manufacturing classified areas
- Perform Aseptic gowning training
3
Experience For QC Associate Lvl-environmental Monitoring Resume
- Assist with troubleshooting and process improvement activities
- Participate in spill control, handling of hazardous materials, and first aid
- Basic understanding of GMPs and of regulatory requirements
- Perform routine monitoring of Personnel
- Calibrate and precision certify analyzers according to EPA Method 21 and maintain complete and accurate records of all calibrations and certifications
- Provide detailed, accurate, field notes for leaks, inventory questions, OELs, routing changes
- Work well with others in a group setting
- Responsible for incubation of personnel and environmental monitoring samples
- Document all activities according to current GMP documentation guidelines
4
Experience For Environmental Monitoring Laboratory Principal Scientist Resume
- Transfer results of monitoring into established data base and review and approve entry by peers
- Alert manufacturing technicians in the event of issues and coordinate repairs
- Follow proper gowning practices for cleanroom environments
- Generates OOS or Out of EM Action/Alert Levels Notification, when required
- Perform research (read literature, interact with vendors, etc.) on assay methods and instrumentation
- Maintain the safety and orderliness of the lab
- Follow safety procedures outlined in the Chemical Hygiene Plan
- Utilize MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated
- Apply knowledge of cGMPs on a daily basis, as applicable
5
Experience For Quality Specialist, Environmental Monitoring Resume
- Follow all established laboratory, regulatory, safety, and environmental procedures
- Adhere to the standards of quality governed by current GMP’s and the company Quality Policies and site SOPs
- Accurately complete required documentation
- Knowledge of MS Office (Word, Excel, Outlook)
- Majority of day spent on feet in the laboratory or clean rooms
- 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
- Update microbiological EM database and prepare reports as requested. Perform maintenance of EM database as well as EM trending
6
Experience For Improvement Engineer Biotech USP Environmental Monitoring Resume
- Able to do occasional weekend work
- Performs cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment. Perform shift cleanings, including spot and more detailed cleanings including sanitizing equipment and components as well as visual inspections
- Conduct process checks to ensure that processes are operating within required parameters
- Create, revise, and assist with preparation of documentation regarding activities, actions, and/or results
- Monitor equipment for performance and problem indicators
- Review completed production documentation (for example: batch records, log books, etc.) for quality, completeness, and cGMP compliance
- Ensure that weights, measures, and raw materials are managed appropriately so that manufactured batches contain proper ingredients and quantities
- Initiate batches in SCADA
- Use SAP to track inventory and materials
7
Experience For Improvement Engineer Biotech DSP Environmental Monitoring Resume
- Monitor production area to ensure compliance with regulatory requirements
- Attend team meetings to discuss progress, and/or continuous improvement initiatives
- Participate in daily shift change meetings
- Wear sterile garments and PPE (Personal Protective Equipment) as required by specific activities
- Train others to perform routine sampling activities to include Environmental & Personnel monitoring, classified room & critical operations monitoringand associated data entry using MODA
- AA with 2 years EM experience in a pharmaceutical/biotech industry
8
Experience For Environmental Monitoring Associate Resume
- AA with 6 years EM experience in a pharmaceutical/biotech industry
- Train others on equipment, machines, procedures, and/or processes
- Knowledge of Standard Methods for Water and Wastewater, USP, CFR and other regulatory guidance specific to the pharmaceutical industry
- Preferable if experienced with EM Lab assays - EM Plates, Nitrates, Conductivity, TOC, LAL, Bioburden, Microbial Water, Growth Promotion, Micro-IDs, pH, Freezing Point, Characteristics, and Specific Gravity. Preferable if experienced with LIMS, Trackwise, SAP
- Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans. Adherence to SOPs, GMPs and safety procedures
9
Experience For Supervisor Microbiology Environmental Monitoring & Utilities Resume
- Provide shop floor quality presence
- Assist with the set up on EM laboratory and manage the EM lab daily operations
- Ensure timely completion and subsequent data review of routine microbiological data
- Facilitate and assist with facility qualification
- Initiate, investigate and complete investigations (Excursions, CAPA, DR) to aid in the determination of root causes
- Train other EM Associates
10
Experience For Environmental Monitoring Technicians Resume
- Provide data entry, review and approval as required
- Compile and evaluate environmental data for adverse trends
- Directly support Performance Qualification activities
- Compile and author Annual Reviews
- Author and summarize Requalification, Performance Qualification, and Special Study protocols
- Perform monthly and weekly sample accountability
- Equipment Calibration and Management
- Performs routine daily, weekly and monthly sampling of water for injection, compressed gas and the environment to detect microbial, non-viable and chemical contamination
- Support manufacturing operations by continuous environmental monitoring viable and non-viable particles
List of Typical Skills For an Environmental Monitoring Resume
1
Skills For Environmental Monitoring Technician Resume
- Basic computer knowledge, Microsoft Word and Excel, email skills
- Write, review, and revise SOPs, work instructions, and MBRs (Master Batch Records) for cGMP (Good Manufacturing Practices) manufacturing of commercial product
- Demonstrate a high level of initiative and motivation
- Three years’ experience required
- Quality experience in pharmaceutical industry
- Quality experience in the pharmaceutical industry
- BA/BS in the Life or Physical Sciences or equivalent relevant experience required
2
Skills For Senior Manager QC Environmental Monitoring Resume
- Experience with microbiology and aseptic technique
- Experience with lab data management systems currently (LIMS/Handel)
- Previous GMP/GLP experience
- Assist with cleanroom move assessments and validations as necessary
- Collecting environmental monitoring samples (viable surface/air and non-viable air) of process areas
- Gowning training and certifications
- Reading of environmental monitoring samples
- Working knowledge of cGMP regulations (21 CFR 201/211/820)
3
Skills For QC Associate Lvl-environmental Monitoring Resume
- Utilizing standard operating procedures to perform their work and making updates to those procedures when necessary in alignment with management
- Assisting with protocol testing as needed
- Collecting environmental monitoring samples (viable surface/air and non viable air) of process areas
- Understanding of aseptic processing and compliance requirements would be beneficial
- Prepping and maintenance of all supplies and equipment
- Handling of Change Controls/CAPA’s and Deviations
- Filing data sheets and document control of logbooks
- Microbiological testing; evaluation of environmental microbiological samples, LAL testing, challenge of incoming materials testing, and bioburden testing
4
Skills For Environmental Monitoring Laboratory Principal Scientist Resume
- Execute environmental sampling of Classified Areas including active air sampling, surface sampling and non-viable air sampling
- Perform Environmental monitoring in an aseptic environment (batch, routine, gowning monitoring and utilities testing)
- Release testing in support of product, including sterility testing, detection of residual moisture, average cell dry weight testing
- Partner with cleanroom custodial team for scheduling of cleaning events and ensuring training is completed
- Outdoor work in petroleum refinery or chemical processing facility walking and standing for prolonged periods of time
- Environmental monitoring to include Active Air and Surface sampling and Water sampling
- Assists and support initiating, investigating and completing investigations, excursions, CAPA, CR and e-checks
- Gather and track a variety of environmental data, including viable (microorganisms) and nonviable (particles) monitoring of manufacturing areas
- Communicate with the manufacturing customers to ensure proper timing of sampling activities. Maintain own equipment
5
Skills For Quality Specialist, Environmental Monitoring Resume
- Assist in updating and revising SOPs for the facility operation, especially raw material management
- Successfully passing any site-specific drug and/or alcohol testing
- Capable of working alone, and managing work loaded that is directed
- Clean steam and compressed gas sampling and testing
- Provide EM support including review, tracking of EM of Microbiology results in support of product release
- Support manufacturing operations by continuous environmental monitoring viable and non-viable particles
- Perform necessary cleaning for the laboratory including pharmaceutical waste
- Trend the results of environmental monitoring and initiating responses as necessary and stay organized
- Review cleanroom custodial, environmental monitoring, and gowning paperwork for data integrity
6
Skills For Improvement Engineer Biotech USP Environmental Monitoring Resume
- Maintain responsibility for EM&C out-of-alert results documentation, including notification and re-testing of alert and action level excursions
- Provide environmental support to manufacturing and testing areas as needed. Perform investigations into environmental excursions
- In laboratory work such as rotation of plates through incubators and reading/counting of the plates collected in the field
- Provide technical and administrative support for all activities to environmental monitoring, documentation, and quality auditing
- Conduct environmental monitoring activities and perform sampling to support the release of production areas and personnel
- Assist in the storage of retention samples and final products according to established procedures and conditions
7
Skills For Improvement Engineer Biotech DSP Environmental Monitoring Resume
- Maintain accurate inventory database of raw materials, samples and products, including MCB and vector stock samples and products
- Assist in monitoring vendor performance, change notifications, material availability, resolve issues
- Assist in coordinating the transfer of samples and products between off-site storage and on-campus storage
- Act as a backup for environmental monitoring of the facility
- Maintain the required technical training and certifications (i.e. cGMP, computer software)
- Suggest quality, safety, and efficiency improvements (i.e. operational flow, labeling, database)
8
Skills For Environmental Monitoring Associate Resume
- Completion of Summit Inspections’ pre-employment physical exam, drug and alcohol testing
- Environmental monitoring plate reads
- Microbiological and chemical sampling of process water
- Responsible for the accurate recording, review and storage of laboratory data
- Ensure proper equipment function, calibration, maintenance and trouble shooting of laboratory equipment
- Knowledge of the EMS system including the ability to assess data in relation to particle excursions and pressure events
- Meet all sterile gowning requirements
- Perform viable and non-viable monitoring of aseptic areas and controlled environments
- Knowledge of all compressed gas and water samples locations and sampling requirements
9
Skills For Supervisor Microbiology Environmental Monitoring & Utilities Resume
- Perform sampling of the water systems and compressed gasses
- Complete documentation accurately and according to cGMP requirements
- Perform microbiology testing such as bioburden, endotoxin, growth promotion
- Ensure proper equipment function, calibration, maintenance and troubleshooting of laboratory equipment
- Provide ongoing technical support to production and other areas within their assigned role
- Collect viable and non-viable/particulate samples from various areas of manufacturing
10
Skills For Environmental Monitoring Technicians Resume
- Handle all types of media plates used in environmental monitoring
- Notify QC Manager that the preventative maintenance of laboratory and testing equipment is due
- Support laboratory in autoclaving cleanroom supplies
- Work independently as well as in a team atmosphere and work flexible hours to support manufacturing operations
- Helps in evaluating new equipment and internal processes
- Lead laboratory investigations and/or support manufacturing investigations, when required
- Perform training on laboratory methods and instrumentation, as needed
- Perform training on laboratory methods and instrumentation
- Work weekends and off-shift hours as needed to support manufacturing activities
List of Typical Responsibilities For an Environmental Monitoring Resume
1
Responsibilities For Environmental Monitoring Technician Resume
- Ensure gowning and de-gowning training and procedures are adequate and reflect current requirements
- Perform necessary cleaning for the laboratory including pharmaceutical waste
- Capable of working alone or on a team, and managing work loaded that is directed
- Provide aseptic training and guidance to manufacturing, maintenance and research and development (R&D) personnel
- Assist with lab maintenance activities required to support these testing services
2
Responsibilities For Senior Manager QC Environmental Monitoring Resume
- Completion of Summit LDAR consent decree (CD), EPA Method 21, and Leak Minimization/First Attempt training
- Completion of Site Specific training programs, and thorough overview of all site specific rules, policies and requirements
- Facilities qualification testing
- Visual inspection (ANSI Testing)
- Perform all required glassware and sterilization for the laboratory
- Order, receive and store laboratory supplies
3
Responsibilities For QC Associate Lvl-environmental Monitoring Resume
- Perform simple routine interpretation of EM results under supervision
- Perform medial fill inspections of vials
- Maintain a safe, clean and organized work environment free from safety hazards
- Follow procedures accurately
- Performs routine daily, weekly and monthly sampling of water for injection, compressed gas and the environment to detect microbial, non-viable and chemical contamination
- Perform all required glassware and sterilization for the laboratory
- Order, receive and store laboratory supplies
4
Responsibilities For Environmental Monitoring Laboratory Principal Scientist Resume
- Maintain a safe, clean and organized work environment free from safety hazards
- Maintain and ensure the environmental quality of cleanrooms
- Manage power outage, spill response, vermin control, and crisis support in the cleanrooms
- Perform 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
- Ensure adequate system controls (policies, procedures, etc.) for clean-room compliance
5
Responsibilities For Quality Specialist, Environmental Monitoring Resume
- Perform and document 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)
- Trained in all aseptic corridors
- Entry of samples into the appropriate system or data sheet
- Verification of particle counts, DP charts and other similar documents for accuracy and/or acceptability
- Insure media, supplies and equipment is acceptable for use
- Trend data in support of investigational activities
- Perform all work in a safe and healthy manner. Ensure safe work practices are being maintained by others, and actively participate in Summit Inspection Weekly Safety Meetings
- Report safety hazards, near misses and injuries per Summit and customer Health & Safety policies and procedures
6
Responsibilities For Improvement Engineer Biotech USP Environmental Monitoring Resume
- When required, perform mid and end of day calibration drift assessments and document results per Summit Inspections’ SOP
- Report problems or potential problems with all analyzers and equipment to supervisor
- If necessary, obtain proper authorization from customer to perform tasks as assigned (permits, etc.)
- Ensure the use of a JSA (Job Safely Analysis) before the start of a task
- Perform visual assessments. Report Open Ended Lines (OEL), Audible, Visual and Olfactory (AVO) emissions, damage, or hazards to appropriate site-specific personnel immediately
7
Responsibilities For Improvement Engineer Biotech DSP Environmental Monitoring Resume
- Perform fugitive emission monitoring per Method 21 and when required per customer site specific monitoring requirements. In real time accurately log observed monitoring results into handheld computer or other methods of recording observed results
- Physically identify leaking components by attaching a weatherproof tag containing leak data and mark leak locations on components with site specific approved method
- Replace/re-hang missing, fallen and/or damaged component identification tags daily, and replace wire on tags as needed
- Report any changes to components inventory for verification and update. Also, report any component not included in inventory for verification and update
- Participate in customer requested odor investigations and maintenance sweeps
- Be organized and work in a systematic and efficient manner
- Take direction and carry out tasks with minimal supervision
- Update SOPs as needed
- Monitor environmental performance within an aseptic area against specifications within classified areas
8
Responsibilities For Environmental Monitoring Associate Resume
- Availability for shift work
- Sit, stand and move within work space for extended periods, ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling; ability to lift up to 50 pounds
- Conduct environmental monitoring throughout the facility, including but not limited to gown, tank and machine, chemical weigh-out rooms, isolators, R&D and personnel according to established SOPs
- Aseptically transfer membrane filters to agar surfaces
- Transport exposed media from test location to incubators
- Record pressure differential values throughout the facility
- Media preparation and storage, autoclave testing materials, testing equipment maintenance, incubator maintenance, cleaning of testing laminar flow cabinets/hoods, proper disposal of samples, etc
- Assist with studies and investigations
9
Responsibilities For Supervisor Microbiology Environmental Monitoring & Utilities Resume
- Assist with the set up on EM laboratory and support the EM lab daily operations
- Facilitate and assist with facility qualification and other facility related EM
- Provide support in development projects
- Understand and follow cGMP regulations
- Understand and follow aseptic gowning requirements and demonstrate good aseptic techniques. Monitor utilities like Water for Injection or Irrigation (WFI), Water for Bulk Sterile Operations (WBSO) and process gases
- Track own schedule to ensure all areas are sampled in a timely manner
- Data entry of the results
- Set - up, maintain and perform various environmental monitoring related activities as required for a cGMP compliant operation according to the applicable guidelines, i.e. FDA, GMP, ICH etc
10
Responsibilities For Environmental Monitoring Technicians Resume
- Follow procedures to collect and process environmental monitoring viable and non - viable samples in a controlled manufacturing aseptic and non - aseptic cleanroom environment
- Perform personnel monitoring for aseptic gown qualification
- Properly record all collected EM samples and maintain documentation in adherence to GDP
- Ensures all work performed strictly adheres to cGMP
- Set - up, maintain and perform various environmental monitoring related activities. as required for a cGMP compliant operation according to the applicable guidelines, i.e. FDA, GMP, ICH etc
- Manage and practice continuous optimization of the site EM Monitoring, Aseptic Technique training, and Gown qualification programs.
- QC Microbiology, QA or production in pharmaceutical or food industry background
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