Sr. QC Analyst – (Contract) – Greater Bay Area, CA – Onsite
Biotechnology company seeks a Senior Analyst within the areas of Analytical QC for a year-long onsite contract opportunity in the Greater Bay area. Ideal candidate will have 5+ years’ experience within regulated pharmaceuticals and be responsible for ensuring integrity and quality of drug substances/products while performing testing in raw materials, in process samples, and finished goods by utilizing advanced lab techniques like ELISA, SDS-PAGE, Western Blot, HPLC. This person will also be responsible for accurate documentation of results, out-of-specification findings investigations, equipment maintenance, and strict adherence to cGMP compliance.

Benefits

• Hourly pay of $50/hr. W2 to $58/hr. C2C.
• A long-term contract with potential extensions.

• BS in Biochemistry or related area is required.
• MS in the same or related fields ideal.
• 6+ years in the regulated pharmaceutical industry.
• Prior experience with biological/physicochemical methods like pH, ELISA, Western Blot, SDS-PAGE, and HPLC.
• Proven expertise authoring/revising HPLC SOPS/Methods, CR/DR/CAPAS, and technical writing.
• Strong understanding of Data Integrity and ALCO+ Principles.
• Experience with HPLC for peptides is desired but not required.
• Reside locally and within driving distance to Fremont area client site.

• Performing testing and analysis of chemical/bioanalytical tests, specifically HPLC (Cation Exchange, Size Exclusion, Reversed Phase) for raw materials, intermediates, and drug substance/products for release and stability programs.
• Ensuring data integrity to include accurately recording, analyzing, and reporting results, while then identifying any deviations from specifications/procedures.
• Authoring/editing documentation like SOPS, protocols, assay worksheets, stability reports, and quality records like lab investigations, deviations, CAPAs, change controls.
• Ensuring cGMP compliance within laboratory regulations (FDA/CDC) pharmacopeia standards, and established procedures.
• Maintaining laboratory equipment to ensure regulatory and internal requirements are met. This includes supporting equipment qualification and onsite vendor support.
• Performing troubleshooting to conduct root cause analysis of quality issues and then collaborating with cross-functional teams on resolutions.
• Managing and tracking inventory to include lab supplies and samples.
• Ensuring safety and proper training occurs to include a safe and secure lab environment and training junior analysts on lab procedures and assays.
• Collaborating closely with cross-functional teams, including Manufacturing, QA, and Analytical Development, to resolve any quality issues, and while supporting process improvements.