Senior Analyst, Analytical Quality Control

Job Description: Senior Analyst, Analytical Quality Control Work Type: Contract Location: Newark, CA (Onsite) Duration: 12 months Position Summary: The Senior Analyst, Analytical Quality Control supports the quality and integrity of drug substances and drug products by performing and reviewing analytical testing in a cGMP environment. This role focuses heavily on HPLC-based methods for biologics and collaborates cross-functionally to support product release, stability programs, and continuous quality improvement. Key Responsibilities: • Perform and review analytical testing of raw materials, intermediates, and finished drug products for release and stability, with a primary focus on HPLC (CEX, SEC, RP-HPLC). • Execute biological and physicochemical assays including ELISA, SDS-PAGE, and Western Blot as required. • Accurately document, analyze, and report data in compliance with cGMP and data integrity (ALCO+) principles. • Investigate out-of-specification (OOS), deviations, and laboratory events; contribute to root cause analysis and CAPA development. • Author, review, and revise SOPs, protocols, assay worksheets, and quality records. • Support laboratory equipment maintenance, qualification, and vendor interactions. • Maintain laboratory readiness, inventory, and safety standards. • Train and mentor junior analysts on laboratory techniques and procedures. • Collaborate with Manufacturing, Quality Assurance, and Analytical Development teams to resolve quality issues and support process improvements. Qualifications: • Bachelor’s degree in Biochemistry or a related pharmaceutical/biotechnology discipline. • 6+ years of experience in a regulated pharmaceutical or biotechnology QC environment. • Strong hands-on experience with HPLC methodologies (CEX, SEC, RP-HPLC); peptide or biologics experience preferred. • Experience performing and peer-reviewing QC analytical data. • Working knowledge of biological and physicochemical methods (e.g., pH, ELISA, SDS-PAGE, Western Blot). • Experience with cGMP compliance, documentation, and regulatory standards. • Strong problem-solving, organizational, and communication skills. Preferred Qualifications: • Master’s degree in a related scientific discipline. • Experience authoring HPLC methods, SOPs, deviations, CAPAs, and change controls. • Experience supporting analytical instrumentation calibration and vendor service activities. Work Environment: • Laboratory-based role requiring use of PPE (lab coat, gloves, safety glasses). • Routine standing, walking, bending, and lifting up to 25 lbs. • Work involves handling chemical reagents and operating analytical instrumentation in a controlled lab environment.