Job Summary:
Performs microbiological testing of raw materials, intermediate/finished products, and environmental bio-burden. Independence, leadership, and technical skills are required to maintain a functional, current and GMP compliant microbiology laboratory. Responsible for continually evaluating the laboratory systems to ensure quality and efficiency. Expected to effect policy with suggestions for improvements. Must be able to handle assignments independently and work with little or no supervision.
Job Responsibilities
- Perform Microbial Limits and Microbial Limits Validation assay of finished products, raw materials, and components.
- Perform bio-burden monitoring of the manufacturing facility and the microbiology laboratory.
- Review the current USP and the regulatory guidance to ensure compliance with updates to microbiological methods.
- Maintain currency with microbiology practices and policies in the pharmaceutical industry.
- Oversee the and maintenance of the USP Purified Water System.
- Author and review microbiology protocols and reports.
- Author, review, and revise microbiology STP's and SOP's.
- Train backup analysts for microbiology tasks in his/her absence.
- Ensure coverage of microbiology assays with back-up analyst for weekend and holiday testing schedules.
- Evaluate trend analysis of microbiology results from tested products, water and bio-burden and author reports.
- Coordinate microbiology testing to complete deliverables in a timely manner.
- Perform IQ/OQPQ on instruments and author the protocols/reports.
- Attend seminars on special topics to continually evaluate improvements to the microbiology laboratory, testing , and policy.
- Act as the microbiology expert for audits and consultations, as required.
- General procurement assignments and responsibilities for the microbiology laboratory: monitor housekeeping, bio hazard waste disposal, sample discard, discard of expired reagents, media preparation, sterilization of waste and glassware, instrument calibration/maintenance/daily monitoring, quarterly expenses report, and inventory/ordering.
- Works as a member of a team to achieve all outcomes
- Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
- Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
- All other relevant duties as assigned
Job Requirements
o Bachelor’s degree in microbiology (B.S.)
o Master’s degree in microbiology (M.S.)
- Knowledge, Skills and Abilities
o Ability to apply advances mathematical concepts such as exponents, logarithms, quadratic equations, linear regression, and permutations.
o Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, and correlation techniques.
o Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
o Ability to read, analyze, and interpret common scientific and technical journals, specifications, standard operating procedures, and standard testing procedures. Ability to write presentations and articles that conform to prescribed style and form. Ability to effectively present information to middle management.
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o Proven strong organizational, time management, and project management skills. Demonstrated experience in coordinating project activities
o Strong organizational, interpersonal and communication skills - excellent command of the English language, both written and verbal
o Ability to be a self-starter, work independently and manage multiple priorities in a fast-paced and changing environment
o Ability to challenge the status quo in an effort to drive systemic change and improvements
o Working knowledge of GMP
o Proficiency with Word, Excel, MS Access, SAP (preferred) and statistical software
o A minimum of 7-10 years of progressively related experience (Bachelor’s degree)
o A minimum of 5-7 years of progressively related experience (Master’s degree)
