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QC Microbiology Analyst
311 Pennington-Rocky Hill Road Pennington, NJ 08534 US
Job Description
- Perform utilities sampling of Water for Injection, Purified Water, Clean Steam and Process gases.
- Perform environmental monitoring of cleanroom suites and laboratory areas as required.
- Perform QC Microbiology laboratory testing including bioburden, endotoxin, sterility, and microbial ID testing to ensure timely generation and reporting of test results (for In-Process, Drug Substance, Drug Product, and Stability samples) in support of manufacturing operations.
- Support routine QC operations, including but not limited to: instrument qualification and maintenance, SOP generation and revision, specification update, record keeping and archival, etc.
- Manage inventory of reagents and supplies for the laboratory.
- Conduct laboratory investigations, including OOS, Out of Trend, deviations, and invalid assays.
- Implement corrective actions and preventive actions (CAPAs).
- Participate in facility qualification activities for microbiological testing and environmental monitoring.
- Required to gown into cleanrooms with different classifications and able to stand and move around for extended periods of time.
- Participate in method transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.
- Undertake any other duties as required.
- Bachelor’s Degree or above in Microbiology, Biology or Biotechnology related scientific discipline.
- Minimum of 2 years of working experience in an FDA-regulated biotechnology or pharmaceutical company.
- 5+ years of experience preferred with no higher education.
- Working knowledge and experience with microbiological testing methods such as endotoxin, bioburden, sterility testing, microbial identification, PCR, biological indicators, environmental monitoring, etc.
- Familiar with USP/EP and cGMP/EU GMP regulations.
- Familiar with instrument and equipment validation.
- Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
- Credible and confident communicator (written and verbal) at all levels.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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