QC Microbiology Resume Sample
Jarvis Lesch
708 Mann Circle,
Detroit,
MI
+1 (555) 249 3836
Work Experience
Manager, QC Microbiology
10/2016
-
PRESENT
Phoenix, AZ
- Perform Micro/EM testing such as, but not limited to, environmental monitoring, Gram stain, sterility, endotoxin, and mycoplasma
- Perform all testing and activities compliantly following appropriate SOPs and Work Procedures
- Perform logbook reviews and monthly laboratory cleaning
- Maintain controls and reference materials to support testing
- Enter/review data in LIMS
- Review QC documents to ensure completeness, accuracy, consistency and clarity
- Generate and analyze trend reports
- Review reports that are generated and makes conclusions as to any action required based on the data
- Develop and revise documents to support process efficiencies and to maintain compliance
Scientist, QC Microbiology
12/2009
-
05/2016
Dallas, TX
- Initiate change controls
- Maintain the gowning qualification program
- Lead and/or participate in investigations/CAPAs
- Support 5S and Lean Lab projects
- Interface with QA and regulatory agencies during audits
- Working knowledge of LabWare LIMS and/or other QC data systems
- Working knowledge of appropriate GMP quality systems (e.g. eSOPs, TEDI, etc.)
- Technical/Professional Knowledge— having achieved a satisfactory level of technical and professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise
- Communication— the individual speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings
QC Microbiology Assoc
06/2004
-
08/2009
Dallas, TX
- Planning/Organizing— the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans
- Adaptability – maintains effectiveness when experiencing major changes in work tasks or the work environment; adjusting effectively to work within new work structures, processes, requirements, or cultures
- Stress Tolerance— maintaining stable performance under pressure or opposition (such as time pressure or job ambiguity); handling stress in a manner that is acceptable to others and to the organization
- Perform Environmental Monitoring (Viable Air, Non-Viable, and Surface Viable)
- Perform Critical Utility Monitoring (WFI, Clean Steam, etc.)
- Perform routine Microbiological assays (Bioburden, Endotoxin, etc.)
- Review and approve testing data produced by peers
- Review IQ/OQ/PQ protocols and final reports for instrument system upgrades
Education
East Carolina University
1998 - 2003
Bachelor's Degree in Microbiology
Professional Skills
- Demonstrates excellent interpersonal and communication skills both written and oral
- Demonstrates good facilitation, organizational and problem solving skills
- Execution of validation protocols for process validation and method validation
- Excellent teamwork, written and oral communication skills. Attentive to detail
- Advanced mentoring and coaching, influencing, negotiating and personal interaction skills
- Excellent technical writing experience such as SOPs, protocols, and reports, and writing analytical sections on microbilogical methods for Regulatory Filings
- Communicate effectively with peers, and demonstrate teamwork, with regards to results or review and corrections required
How to write QC Microbiology Resume
QC Microbiology role is responsible for training, languages, documentation, planning, purchasing, reporting, manufacturing, design, events, software.
To write great resume for qc microbiology job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For QC Microbiology Resume
The section contact information is important in your qc microbiology 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 QC Microbiology Resume
The section work experience is an essential part of your qc microbiology 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 qc microbiology responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular qc microbiology position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative QC Microbiology resume experience can include:
- Good Knowledge and experienced in Microbiology Laboratory Practices
- Having experiences min. 2 years in QC within Pharmaceutical, Food & Beverages or FMCG industry
- Demonstrated successful management of Environmental monitoring, Personnel monitoring in manufacturing suites and successful management of QC Microbiology labs
- Provide an effective and efficient QC Service to operations by supervising, developing and coaching the QC team
- Experience in testing of sterile drug product and aseptic filling process of sterile pharmaceutical /biopharmaceutical products
- Good knowledge of current regulatory requirements for QC / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing
Education on a QC Microbiology Resume
Make sure to make education a priority on your qc microbiology resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your qc microbiology 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 QC Microbiology Resume
When listing skills on your qc microbiology 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 qc microbiology skills:
- Demonstrated strength in communication, both written and verbal, with proven leadership skills and training experience
- Strong leadership skills with 8+ years of progressive microbiology laboratory management experience in a pharmaceutical or biotech industry
- Excellent organization skills on planning its own work and of the team
- Effective communication skills in both languages
- Having good understanding in Pharmaceutical Good Quality Control Practices and GMP
- Intermediate knowledge of Good Engineering Practices and Validation Principals
List of Typical Experience For a QC Microbiology Resume
1
Experience For Scientist, QC Microbiology Resume
- Makes decisions regarding testing priorities to complete analytical test results following established cycle times
- Participate in validation, troubleshooting various types of equipment including proactive resolution of instrument issues
- Manage Kite EM and Micro departments at Kite sites. Establish, validate and sustain environmental monitoring program for Kite Pharma sites
- Advanced hands on experience with various microbiology techniques and environmental monitoring
- Experience with a LIMS system preferable
2
Experience For QC Microbiology Supervisor Resume
- Prepping of materials requiring sterilization
- Working knowledge of LIMS
- Ensuring high cGMP, GLP standards are maintained while testing
- Deep understanding of experimentation and data analysis and data trending using different statistical software packages
- Completes tasks where judgment is required in resolving problems & making recommendations
- Ensures raw material and product release testing and stability testing activities are conducted in a timely manner
- Directs the Environmental Monitoring program in support of the sterile manufacturing operations
- Responsible for managing the Aseptic Gowning and Qualification program
3
Experience For Manager, QC Microbiology Resume
- Maintain identification program of microbial isolates from environmental monitoring and product related testing
- Performs environmental monitoring during fill operations
- An understanding of cGMP, CFR, USP, and aseptic processing guidelines is required
- Assemble data and write reports on findings from environmental monitoring of Kite’s cGMP facility
- Able to clearly present results of work, interpret data using standard statistical software and draw conclusions
- General understanding of pharmaceutical GMPs and 21CFR Part 11, EU and Japanese pharmaceutical regulations
- Perform environmental monitoring of cleanrooms
- Perform microbiological assays such as Gram Stain, Endotoxin, Sterility, Microbial Identification, Growth Promotion, Bioburden and Plate Reading
4
Experience For QC Microbiology Assoc Resume
- Assist in investigations regarding out of specifications (OOS) results, address and manage deviations related to micro procedures
- Inform supervisor/manager upon observing OOS, OOL, or generation of deviations
- No critical observations during internal or external inspections
- Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner
- ≥95% training completion
- Defines complex issues. Recommends and guides implementation of functional strategies across group
- Provides frequent overall departmental feedback to senior management
- English language (passive and active)
- Ensure all necessary documentation to trace each analysis: No. lot and preparation of reagents, equipment used, calibration, batch number and expiry consumables ..
5
Experience For Supv, QC Microbiology Resume
- Ensure that the Microbiology laboratory maintains compliance with cGXP, ISO, governmental regulations, Valeant Directives and local procedures, applicable aseptic and sterility guidance’s
- Reviews and approves laboratory data and investigations in accordance with cGMP’s and good documentation practices
- Create and ensure departmental compliance with safety programs and promote a culture of safety within the microbiology laboratory and the Union City Site
- Participate in and/or lead OOS and other quality investigations. Participate and assist in internal and external audits
- Investigate and resolve customer complaints as needed
- Provides subject matter expertise to other departments as part of cross-functional project teams
- Follow established procedures and requirements to execute assigned tasks
- Demonstrated technical writing skills within a highly regulated environment, including documentation of investigational testing and problem solving techniques related to nonconformances (NC)
- Learn new techniques, perform multiple tasks simultaneously, follow instructions, and comply with company policies
6
Experience For Associate Analyst, QC Microbiology Resume
- Theoretical knowledge of subject matter, CGMP, FDA guidelines, ISO guidelines, GLP and USP’s
- Directs all functional accountabilities for the Quality Control Microbiology Laboratories in accordance with organization’s policies and procedures
- Ensures timely availability, reliability and accuracy of the test data
- Oversees the investigation of microbiological quality problems in raw materials, in- process, finished products, utilities and facilities, and environmental monitoring in order to analyze and propose corrective actions to prevent reoccurrence and to recommend disposition of products
- Participates in production planning process, prepares budgets, recommends capital expenditures for technology and equipment, and allocates human resources to support manufacturing, testing, and investigations
- Reviews/Approves all new and revised QC Microbiology related SOP’s to ensure compliance with cGMP’s
- Performs technical review of JP, BP, USP and Supplements, and the USP Pharmacopeial Forums to ensure methodology and procedures are compliant with current standards
- Participates in audits conducted by regulatory agency representatives
7
Experience For Senior Analyst, QC Microbiology Resume
- Oversees site Aseptic Process validation program and provides technical input related to aseptic processing line configurations, changes, and sterility investigations
- 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
- Monitor and trend data for EM and PM readings. Update management on environmental trends. Implement corrective action plans when necessary
- Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies and interact with agents from Regulatory agencies and participate in Pre-Approval and post approval inspections
- Work independently with minimal supervision and ability to identify, effectively communicate, and troubleshoot issues
- Experience in data management, change control, GMP and compliance
- Give weekly updates to your manager on time
8
Experience For Director, QC Microbiology Resume
- Strong experience in developing Microbiological assays, (Sterility, Mycoplasma, Endotoxin and Gram Stain), ELISA and other routine chemical tests and strong experience in managing testing by compendial methods
- Communicate complex scientific findings and recommendations in one-on-one discussions and in departmental meetings
- Strong computer, scientific, and organizational skills. Ability to work independently and as part of a team with internal and external teams with excellent communication skills
- Exceptional analytical skills to evaluate the importance and urgency of problems; demonstrated interpersonal, verbal and written communication skills
- Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes
9
Experience For QC Microbiology Specialist Resume
- Experience in aseptic techniques and clean room operations
- Review laboratory data in accordance with cGMP’s and good documentation practices
- Pass vision exam for visual inspection
- Knowledge of GMP, SOPs and quality control processes
- Be flexible with schedule, and work overtime as needed
- 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
- Collect viable and non-viable samples within controlled environments
- Collect viable and non-viable samples for compressed gases
10
Experience For Manager QC Microbiology Resume
- Collect personnel glove and gown samples
- Lead and be accountable for team’s performance and results
- Daily inter-departmental interactions and communications, as liaison for Quality Control, including the training of technicians on microbiology and aseptic technique
- Along with EM coordinator, track and trend EM data, with focus on microbial organism trending. This includes the preparation of analytical reports, trend analysis reports and summaries as required
- Assure the management of the budget, guaranteeing the control of costs on services according to the company objectives
List of Typical Skills For a QC Microbiology Resume
1
Skills For Scientist, QC Microbiology Resume
- Related experience or equivalent combination of education & experience
- Demonstrated experience with aseptic technique
- Computer skills (MS Office, MS Project) or comparable word-processing and spreadsheet applications is required
- Experience with operation, maintenance, and troubleshooting of laboratory equipment and instrumentation related to analytical testing
- Document laboratory test results on worksheets and forms utilizing Good Documentation Practices
- Good Manufacturing Procedures and other regulatory requirements
- Solid understanding of applicable regulatory requirements
2
Skills For QC Microbiology Supervisor Resume
- Participates in Microbiological Testing validation exercises
- Relevant work experience required, preferably in a manufacturing environment with cGMP requirement
- Experience in environmental control and monitoring of clean rooms and utilities required
- Validation and technology transfer of analytical methodologies supporting the microbiology laboratory
- Intermediate written and verbal communication skill
- Relevant work experience required
- Efficiently prioritize, manage and complete multiple projects and tasks in a fast-paced environment
3
Skills For Manager, QC Microbiology Resume
- Experience in cGMP Quality environment
- Demonstrates ability to work under minimal direction and as part of a team
- Experience in cleanroom environment
- 4 – 5 years lab experience in Pharmaceutical or Medical Device Industry
- Rare in our background and experiences
- Demonstrated ability to adhere to protocols and directives in a laboratory environment
- Experience with MODA™ or LIMS software
- Ensuring training is current for all job function performed and attend all company training as required
4
Skills For QC Microbiology Assoc Resume
- Maintaining relations with the laboratory equipment producers and material consumers, giving to the Purchasing Office a guide for the suppliers’ choice
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
- Performs environmental monitoring, water sampling, endotoxin testing to support manufacturing
- Performs microbiological testing following laboratory methodology, such as Testing Standard, General Method, Specific Method, Pharmacopeia Compendia, and SOPs
- Perform LAL (Endotoxin) testing using Kinetic Turbidimetric and Kinteric Chromogenic method
- Perform microbial identification on Environmental Monitoring samples In Process Testing samples, and for other groups
5
Skills For Supv, QC Microbiology Resume
- Assist in revising Standard Operating Procedures, as needed
- Ensures sampling, testing and release timelines are met
- Lead and maintain the development of Microbiology laboratory testing data and trending
- Implementation, revision of, and performing testing described in QC SOP and other procedures
- Assists with special projects by supporting the development of new sampling methods or investigations as required
- Reviews laboratory documentation from peers to ensure testing was performed according to laboratory methodology and accuracy
- Works with manufacturing operations to promote awareness and importance of Valeant environmental monitoring directives and microbiological control
- Participate in aseptic process qualifications, such as aseptic gowning and media fill reads
6
Skills For Associate Analyst, QC Microbiology Resume
- Perform Bacterial Endotoxin and Sterility Testing on in- process, stability and finished drug products
- Perform mycoplasma testing via PCR
- Evaluate environmental/personnel monitoring samples and create NOEs for action levels
- Performs general laboratory cleaning/wipe-down
- Sample and test Environmental Monitoring samples
- Preparation and testing of both in-process and finish product samples in accordance with written procedures and best practices
7
Skills For Senior Analyst, QC Microbiology Resume
- Participate and compile Laboratory investigations using Root Cause Analysis tools
- Organize/plan/Schedule daily work schedules for assigned work /Equipment calibration or as part of a specific project using lean lab concepts
- Responsibility for ordering of Laboratory Consumables and maintain sufficient stock levels
- To maintain a high standard of housekeeping and Safety within the Laboratory
- Intermediate understanding of statistics, control charts, action and alert limits
8
Skills For Director, QC Microbiology Resume
- Knowledge of QC testing principles and procedures, as applicable to focus of position
- Gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs
- Responsible for maintaining environmental isolate library, and growth promotion program
- Able to work M-F 1st shift including occasional weekends and holidays
- Receives and controls microbiological samples submitted for testing in the Microbiology Laboratory
9
Skills For QC Microbiology Specialist Resume
- Utilize scientific principles to assist in microbiological testing methods and the proper use of laboratory equipment
- Adaptability – Maintain positive attitude in a changing work environment
- Knowledge and understanding of cGMPs, USDA, EU, and other regulatory requirements
- Ensures in-process and final product sterility testing of product conforms to company standards and satisfies GMP regulations
- CGMP and microbiology laboratory compliance to regulatory guidelines
- Expert understanding of Sterility and Aseptic Guidance’s, governmental regulations, industry standard in microbiology testing standards and insight into future testing trends (e.g. rapid micro techniques)
- The Associate/Sr. Associate (Microbiology) works both independently and with the team to perform routine and non-routine microbiological testing and microbiology laboratory maintenance functions, where necessary
- Communicate effectively with QC peers, cross-functional peers and management
10
Skills For Manager QC Microbiology Resume
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times
- Perform microbial identification via polymerase chain reaction (PCR)
- Perform microbial isolation techniques and perform Gram stain identifications
- Send out samples to contract labs and track results/reports
- Perform routine maintenance of lab equipment
- Under the guidance of management, support special project work
List of Typical Responsibilities For a QC Microbiology Resume
1
Responsibilities For Scientist, QC Microbiology Resume
- Strong microbiology skills
- Experience of working with teams and influencing decisions
- Ensure that Microbiology lab test results which exceed the specification limits investigated, and effective CAPAs are implemented
- Support validation/verification and qualification of test methods and processes
- Experience in managing/leading teams preferential
- Excellent knowledge of LIMS
- Experience in cross-functional teams and knowledge of applicable regulatory inspections is desirable
- Relevant work experience, preferable in a regulated environment
2
Responsibilities For QC Microbiology Supervisor Resume
- Exposure to cGMP environment. Audit experience
- Significant laboratory documentation review and revision experience
- Coordinates sampling responsibilities to ensure support according to the needs of Manufacturing to maintain continuous process flow
- Become proficient in Microbial techniques such as Gram staining, dilutions, filtering, and evaluation of plates and test tubes for microbial growth
- Lead a team of analysts in QC by coordinating daily operations and ensuring tasks are complete to meet business needs
3
Responsibilities For Manager, QC Microbiology Resume
- Support qualifications of HVAC and water systems on site and following transition into routine testing
- Drive process improvement using Six Sigma and MPS tools
- Climb and move about in an environment among machines with moving parts and ladders/stairs
- Assist Manufacturing and Facilities to solve microbiology related deviations/issues
- Collects and reviews Sterilization Bar Code Accountability and Packing Sterilizer Tag Verification/ Accountability for accuracy and completeness
4
Responsibilities For QC Microbiology Assoc Resume
- Reviews sterilization related deviations, initiate failure investigations, and recommends disposition of nonconforming lots
- Become proficient in environmental monitoring techniques specific to Microbiology
- Investigates sampling abnormalities and implements corrective action
- Maintains laboratory sampling supplies to ensure an adequate supply and prevent delays
- Audits documentation, device history records, and sampling methods for compliance
- Development and management of SOPs, forms, and methods required to support the compliant operation and testing conducted in the Microbiology laboratory
- Act as microbiology subject matter expert for site investigations
5
Responsibilities For Supv, QC Microbiology Resume
- Oversee implementation of in-house testing capabilities in the QC laboratory, including bioburden, endotoxin, and sterility assays as well as microbial identifications as required
- Guarantee the formal compliance of the Ministry of Health and the International Regulatory Authorities through the registrations concerning the quality controls made and through the stability controls keeping representative samples of production batches
- Collaborate with the local unities providing the necessary specialized laboratory assistance in the realization of programs finalized to the improvement of processes and products
- Promote the update of analysis plans, ensuring the optimal use of human and technological resources to improve efficiency of the service
- Guarantee the right implementation of stability controls on the batch samplings of previous years for products on the market
- Collaborate with the Technical Direction in the management of quality system, reporting periodically the results of the evolution of activities and promoting improvement actions of the system
- Guarantee, through the recurring calibration of tools, the accuracy of the laboratory tests
- Competent in use of Microsoft Office programs, LIMS, and QMAS
- Wear protective or safety equipment such as safety shoes, glasses, gloves
6
Responsibilities For Associate Analyst, QC Microbiology Resume
- Work indoors in an environmentally controlled area
- Manages the Quality Control Microbiology department daily work activities including: workload, ensuring training, general guidance to direct reports and across functional groups, and serves as resource for technical / administrative problems
- Supports development of novel QC microbiological methods and expands throughput of laboratory looking at new technology for integration. Works in conjunction with other departments to develop, qualify, and transfer QC microbiological methods
- Leads the CAPEX process for QC Microbiology; including commissioning and qualification of new equipment, instruments, including major capital projects and computer systems
- Collaborates significantly with cross functional groups, including QC Analytical, QA, Validation, Manufacturing, Process Development, Facilities, and Regulatory Affairs
- Become proficient in finished product and raw material testing as required, i.e. Sterility, LAL, Bioburden and Electronic PM
7
Responsibilities For Senior Analyst, QC Microbiology Resume
- Supervise a team of Microbiologist in the Quality Control department
- Perform LAL and Bioburden testing of environmental monitoring samples, in-process samples, raw materials, equipment rinses and bulk drug substance using Chromogenic, Turbidimetric method and Membrane Filtration, and Pour plate method, respectively
- Perform document review and approval, as required
- Collects, sorts and verifies Sterilization Tags for accuracy and completeness
- Collects Split Load Verification Forms (SLVF)s, Quality Control Sterilization Release Checklist, Product/ Process Deviation Reports (PPDR)s, Event Report Forms (ERF)s, Equipment Failure Reports (EFR)s Quality Control Reports (QCR)s, Quality Control Investigations (QCI)s, and review them for accuracy and completeness
- Reviews sterilization cycle data and generates Sterilizer Load Reports (SLR)s from the PLC sterilizer control system
- Sorts SLRs and QCRs/QCIs for deviations
- Records Sterilization information on the SLVFs
- Generates QCRs and data dump from the SMS system
8
Responsibilities For Director, QC Microbiology Resume
- Uploads and reviews SLR, QCR and/or Foxboro report in the MES Electronic Batch Record (EBR) system for accuracy and completeness
- Reviews and/or approves SLRs, QCRs and Foxboro report for product related, Production Test Run Authorization (PTRA), and Engineering Test Run (ETR) for accuracy and completeness
- Familiarity with Sterilization Bar Code system (SBC), Production Specification System (PSS), Sterilization Verification System (SVS)
- Initiates Discrepancy Management System (DSMS) from SAP system
- Performs Manual Release per appropriate procedure
- Coordinates activities with Sterilization Production and Maintenance to resolve process deviations. Investigates deviations during steam sterilization process for PPDRs/ DSMSs
- Keeps track of PPDRs, DSMSs and ERFs
- Prepares formal report of the sterilization PPDRs and DSMSs for management review
- Updates and revises sterilization procedures as needed
9
Responsibilities For QC Microbiology Specialist Resume
- Obtains GMP Qualified Trainer
- Intensive knowledge of Steam Sterilization Process
- Functions as a team member in the QC Microbiological Laboratories to provide timely sample information on the status of conformance to requirements
- Performs growth promotion, sterility, and viability tests to culture media
- Reports analytical test results in applicable computerized systems
- Generates Laboratory Investigations for test results outside of specification and Quality Events
10
Responsibilities For Manager QC Microbiology Resume
- Performs and documents Laboratory Investigations and Quality Events Investigations
- Revises laboratory methodology to reflect actual practices
- Prepares culture media and laboratory solutions
- Identifies microorganisms in accordance with laboratory methodology
- Verifies calibration of equipment to ensure they are suitable for use
- Assures there is adequate inventory of purchased microorganism, culture media, reagents, and laboratory supplies used in the Microbiology Laboratory
- Handles and properly disposes potentially dangerous, regulated hazardous wastes into a designated on-site disposal facility or interim storage container
- Files appropriate logs and forms and takes the necessary corrective action in the event of an incident such as a spill, fire or explosion
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