Specialist, Quality CMC Operations

Role: Quality Specialist supporting Phase 1-3 biopharmaceutical pipeline products, focusing on batch record review, product release, and QA metrics. Responsibilities include batch disposition activities—reviewing and approving documentation for drug substances, drug products, and medical devices—generating certificates of release, maintaining compliance with regulatory standards, collaborating with cross-functional teams to resolve quality issues, and driving continuous improvement in QA processes. Qualifications: Bachelor's in Chemistry, Life Sciences, or related field; minimum of 3 years’ experience in pharmaceutical QA, with expertise in batch record review, product release, and cGMP compliance. Preferred skills include familiarity with electronic document management systems like Veeva Quality Vault, and experience with pharmaceutical manufacturing and analytical labs. High-value specifics: supporting Phase 1-3 pipeline products, regulatory compliance, GxP standards, and cross-functional collaboration. Work setup: hybrid role based out of Bridgewater, NJ, with occasional domestic/international travel (~10%).