Quality Management Specialist II
United Pharma
Seeking a Quality Management Specialist to support batch record review, product release, and quality operations for commercial and clinical pharmaceutical products. Responsibilities Perform batch record review to support product release activities Manage quality events, deviations, change controls, and CAPA in TrackWise Review investigations, root cause analysis, OOS, and analytical documentation Support creation and maintenance of specifications, BOMs, and Master Batch Records Collaborate with Technical Operations, QA, QC, and external partners Identify trends and maintain quality trackers during batch review Ensure compliance with GMP regulations and internal quality standards Qualifications 5+ years of QA/QC or pharmaceutical manufacturing experience Strong batch review and release experience Experience with TrackWise or similar QMS tools Knowledge of FDA 21 CFR Parts 210 & 211 and GMP requirements Biologics or monoclonal antibody experience preferred Bachelor’s degree in Chemistry, Biology, or related science #J-18808-Ljbffr United Pharma
Vacancy posted 3 days ago
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