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Quality Management Specialist II
Job in
Newark, Essex County, New Jersey, 07175, USA
Listed on 2026-06-07
Listing for:
United Pharma
Full Time
position Listed on 2026-06-07
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst -
Healthcare
Data Scientist
Job Description & How to Apply Below
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 Track Wise
- 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
- 5+ years of QA/QC or pharmaceutical manufacturing experience
- Strong batch review and release experience
- Experience with Track Wise 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
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