Sr. Specialist, Quality Assurance

Role: Senior Specialist, Quality Assurance, providing hands-on QA oversight within the Quality Systems team for biologic drug manufacturing. Responsibilities: ensure compliance with GxP and regulatory standards; coordinate and track quality records such as change controls, deviations, CAPAs, and investigations; oversee validation and qualification activities for Facilities, Utility Systems, Equipment, Analytical Instruments, and Computerized Systems using risk-based approaches; support Data Integrity Program and quality metrics development; assist in audits and inspections, and contribute to continuous improvement of quality systems. Requirements: Bachelor's degree in Biology, Chemistry, or related science; 6+ years of industry experience, including at least 4 years in QA; strong knowledge of 21 CFR Parts 210-211, Eudralex Volume 4, ICH guidelines; experience with aseptic processes and biologics preferred. HighValue: biologics, GxP facilities, Utilities, Equipment, Analytical Instruments, Computerized Systems, Data Integrity, biologics manufacturing, regulatory compliance (US and international cGMP). Collaboration: cross-functional with Quality Control, Manufacturing, Facilities, IT, Supply Chain, and Regulatory Affairs. WorkSetup: hybrid Newark, CA (3 days/week in-office); moderate travel not specified.