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QC Raw Material Analyst

Pennington, NJ 08534

Posted: 05/07/2024 Employment Type: Contract Job Category: Scientific Job Number: 602247 Is job remote?: No Country: United States

Job Description


General Description:

Perform QC sampling and chemistry testing of raw materials under FDA/EU regulations, applicable International Regulations, processes and procedures to support GMP manufacturing. 

Essential Functions of the job:
  • Perform compendial (USP/EP) testing of raw materials (starting materials, excipients, primary packaging, manufacturing water).
  • Perform QC sampling and chemistry laboratory testing of raw materials (starting materials, excipients, primary packaging, manufacturing water) to ensure timely generation and reporting of test results in support of manufacturing operations.
  • Perform routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, specifications generation and revision, raw material sampling and testing, record keeping, etc.
  • Support QC sample management with the receipt of in-process samples and issuance of controlled documentation
  • Manage receipt and inventory of reagents and supplies for the laboratory.
  • Participate in internal and external GMP audits where possible.
  • Undertake any other duties as required

Education Required:
  • Minimum of 2+ years with a Bachelor’s or above in Chemistry or related scientific discipline.
  • 5+ years of experience preferred with no higher education.

Core Competencies, Knowledge, and Skill Requirements
  • Scientific degree (ideally chemistry, biochemistry, biotechnology or related).
  • Working experience in an FDA-regulated biotechnology or pharmaceutical company is required.
  • Working knowledge and experience with raw material sampling in a cleanroom environment.
  • Working knowledge and experience with physiochemistry analytical methods such as HPLC, GC, TOC, FTIR/NIR/Raman, Karl Fischer, osmolality, melting point, optical rotation, and wet chemistry compendial methods.
  • Working knowledge with USP/EP and cGMP/EU GMP.
  • 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.
  • Strong analytical and problem-solving ability.
  • Hands-on approach, with a ‘can do’ attitude.
  • Ability to prioritize, demonstrating good time management skills.
  • Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
  • Self-motivated, with the ability to work proactively using own initiative.
  • Committed to learning and development.

Computer Skills:   
  • Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

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 and The Planet Group of Companies are equal opportunity employers. 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.