QC Analyst, Analytical

Revance • Newark, CA

8h • $77,000 - $97,000 • Onsite

About The Position

The Analyst in Analytical Quality Control ensures integrity and quality of drug substances and products by performing testing of raw materials, in-process samples, and finished goods using advanced laboratory techniques (e.g., ELISA, SDS-PAGE, Western Blot, HPLC). This role is responsible for accurate documentation of results, investigation of out-of-specification findings, equipment maintenance, and strict adherence to cGMP standards. We are looking for a quality control analyst with extensive HPLC (preferably with biologics) experience to support our current portfolio and pipeline.

Requirements

• Bachelor of Science in Biochemistry, or a related pharmaceutical biotechnology discipline
• 4+ years of regulated pharmaceutical industry experience
• Must have experience with a range of biological and physicochemical methods.
• Must have experience in peer-reviewing of Quality Control data.
• Must have experience with a wide range of HPLC methodologies (CEX, SEC, RP-HPLC).

Nice To Haves

• Master of Science in Biochemistry, or a related pharmaceutical biotechnology discipline
• Effective written and verbal communication skills
• Experience with a range of biological and physicochemical methods (pH, ELISA, Western Blot, SDS-PAGE, HPLC)
• Proficient understanding of data integrity and ALCO+ principles
• Experience supporting analytical instrumentation calibrations (work orders, reports, etc.) with vendors a plus.
• Experience with HPLC for peptides is a plus.

Responsibilities

• Testing & Analysis: Performing and reviewing of chemical/bioanalytical tests, specifically HPLC (Cation Exchange, Size Exclusion, Reversed Phase) for raw materials, intermediates, and drug substance and drug products for release and stability programs.
• Data Integrity: Accurately record, analyze, and report results, identifying any deviations from specifications and procedures.
• Documentation: Write/review SOPs, protocols, assay worksheets, stability reports, and quality records such as laboratory investigations, deviations, CAPAs, and change controls.
• Compliance: Ensure the laboratory is in cGMP compliance with regulations (e.g., FDA and CDC), pharmacopeia standards, and established procedures.
• Equipment: Maintain laboratory space to regulatory expectations and internal procedures regularly, including support of equipment qualification and onsite vendor support.
• Troubleshooting: Conduct root cause analysis for quality issues and collaborate with cross-functional teams for resolutions.
• Inventory: Manage lab supplies and samples
• Safety and Training: Ensure a safe and secure laboratory environment, providing training to junior analysts on laboratory procedures and assays.
• Collaboration: Work closely with cross-functional teams, including Manufacturing, Quality Assurance, and Analytical Development, to resolve quality issues and support process improvements.

Benefits

• Competitive Compensation including base salary and annual performance bonus.
• Flexible PTO (12 days' PTO), holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level