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.
• 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.