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Quality Control Scientist
3 months ago
Job Title: QC Raw Materials Scientist
Location: Princeton, New Jersey
Position Overview: We are seeking a skilled and motivated QC Raw Materials Scientist to join our Quality Control team. This role involves performing QC sampling and chemistry testing of raw materials to support GMP manufacturing, in accordance with FDA/EU regulations.
Key Responsibilities:
- Technical Documentation: Author and review technical documents including SOPs, Test Methods, Method Verification/Validation Protocols & Reports, and Material Specifications.
- Compendial Testing: Conduct compendial testing (USP/EP) of raw materials such as starting materials, excipients, primary packaging, and manufacturing water to support manufacturing operations.
- Method Verification/Validation: Perform method verification and validation of raw material test methods.
- Sampling: Execute QC sampling of raw materials in a cleanroom environment.
- Instrument Qualification: Lead the qualification of QC analytical instruments by authoring and executing IQOQ protocols and reports.
- Investigation Management: Lead investigations into OOS (Out of Specification) results, lab discrepancies, and invalid assays.
- Sample Management: Support QC sample management by receiving manufacturing samples.
- Inventory Management: Manage the receipt and inventory of reagents and supplies for the laboratory.
- Audit Participation: Participate in internal and external GMP audits as needed.
Skill Requirements:
- Education: Scientific degree in chemistry, biochemistry, biotechnology, or a related field.
- Experience: Proven experience in an FDA-regulated biotechnology or pharmaceutical company. Experience with raw material sampling in a cleanroom environment is essential.
- Analytical Skills: Proficiency in chemistry analytical methods such as HPLC, GC, TOC, FTIR, Raman spectroscopy, Karl Fischer, osmolality, melting point, optical rotation, and wet chemistry compendial methods.
- Regulatory Knowledge: Strong working knowledge of USP/EP and cGMP/EU GMP standards.
- Technical Writing: Demonstrated experience in technical writing.
- Validation Experience: Familiarity with instrument and equipment validation.
