Quality Associate II in Princeton
Listed on 2026-07-02
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Quality Assurance - QA/QC
Data Analyst
Quality Associate II
12 month contract Must be able to work on a W2 On-site in Princeton, NJ
Requirements• Ensures GMP compliance for outsourced clinical manufacturing, packaging, labeling, and testing activities.
• Performs QA review of small molecule Drug Product manufacturing and/or packaging batch records for OPDC Investigational Development Product (IMP) and/or Commercial Product for accuracy and compliance with Otsuka and GMP requirements.
• Utilizes the Track Wise Digital eQDMS System to enter batch related information and complete associated batch disposition workflow.
• Escalates project/supplier issues/trends to GPQ Management when appropriate to ensure timely resolution.
• Works collaboratively with OPDC Vendors as well as the GPQ Department and other functional areas across Otsuka Affiliates and Subsidiaries to ensure Compliance with local and global requirements and regulatory requirements.
• Maintains GMP records (document storage, archiving, retrieval)
• Reviews analytical test results/raw data to ensure results meet specifications and are appropriately documented. Approves data in LIMS to support stability studies on an as needed basis.
• Reviews Vendor quality events, deviations, investigations, and change controls in conjunction with related executed batch records to assess acceptability of the batch.
• As "Assigned To" completes any Quality Event related record (including but not limited to Action Items, CAPA, PQC investigation records etc.) within Track Wise on an as needed basis.
• Supports GPQ Metrics/Dashboards/Management Reviews by compiling batch record review/release data and/or other ad hoc reporting requests.
• Supports Track Wise Digital Quality process improvement projects (UAM/UAT testing)
• Bachelor's degree in Engineering, Chemistry, Biology, or related Science
• 2-5 years of related experience in pharmaceutical industry in a Manufacturing, QA or QC role supporting GMP activities for Investigational Medicinal Product/Clinical Trial Material
• Ability to work independently.
• Ability to handle interactions and resolve issues with internal customers and GMP Vendors in a tactful, professional, and effective manner.
• Ability to manage and prioritize multiple tasks.
• Experience using MS Office (Word, Excel, PowerPoint) as well as collaborative applications/repositories such as Teams/Sharepoint
• Experience using Track Wise Digital or similar eQDMS workflow interface.
• Excellent interpersonal and communication skills
• Thorough understanding of GMP requirements and the Drug Development process.
• Analytical problem solving and decision-making skills.
• Ability to identify gaps/risks and propose corrective and preventative actions.
• Experience with review/disposition of bulk drug products and/or commercial packaging records.
• Working knowledge of the Track Wise digital application
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