Senior Specialist, Quality Assurance – Drug Substance
$115,000–$135,000 year
Remote · United States
Job Summary
Senior Specialist, Quality Assurance – Drug Substance executes QA activities supporting clinical and commercial manufacturing of drug substance in cGMP compliance. Responsibilities include batch record review, vendor oversight, and ensuring accuracy and completeness of GMP documentation across internal and external manufacturing operations; supports tech transfer, process validation, routine GMP operations, and inspection readiness within the Commercial QA team. Collaborates cross-functionally to improve QA systems and documentation workflows, with emphasis on deviations, CAPAs, change controls, and analytical documentation related to API/drug substance release testing, stability programs, and validation activities.
Required Qualifications
- Bachelor’s degree (BS/BA) in a relevant scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, or related field)
- Minimum of four to six (4–6) years of experience in Quality Assurance and/or Quality Systems within the biotechnology or pharmaceutical industry
- Direct experience supporting GMP-regulated drug substance/API manufacturing, including batch record review, process validation support, and documentation compliance
- Experience supporting contract manufacturing organizations (CMOs) or external vendors in a QA capacity
- Hands-on experience with quality systems such as deviations, CAPAs, change control, and/or OOS investigations
- Working knowledge of cGMP regulations, FDA guidelines, ICH standards, and industry best practices related to drug substance/API manufacturing and process validation
- Ability to review and interpret technical documentation (batch records, validation protocols/reports, analytical data)
- Strong organizational skills with the ability to manage multiple priorities and meet deadlines
- Proficiency with electronic quality systems and document management platforms
- Ability to travel domestically and internationally (~20%) as needed
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