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QC Microbiology Analyst

Pennington, NJ 08534

Posted: 01/15/2025 Employment Type: Contract Job Category: Scientific Job Number: 616901 Is job remote?: No Country: United States

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.
Requirements:
  • 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.

 

The staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Pennington, NJ

Join us in exploring exciting job opportunities in the vibrant community of Pennington, New Jersey! Nestled in the picturesque Mercer County, Pennington offers a perfect blend of small-town charm and big-city amenities. With proximity to the beautiful Rosedale Park and Mercer Meadows, it's a haven for outdoor enthusiasts. Discover local art at the prestigious Morven Museum & Garden or catch a show at the Pennington Players Theatre. Indulge in delicious cuisine at the local farm-to-table restaurants or cheer on the Trenton Thunder baseball team at the Arm & Hammer Park. Embrace the unique culture and endless growth opportunities in Pennington – the perfect place to advance your career!

Although this hasn't been an issue at Planet Pharma, the staffing 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 and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.