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Quality Assurance Specialist

BioTalent

We are partnering with a leading biopharmaceutical manufacturing organization seeking a Quality Assurance Specialist (Lot Disposition) to support batch review, lot release, and quality oversight activities in a cGMP-regulated environment. This position plays a critical role in ensuring manufacturing and quality records are compliant, complete, and ready for product disposition while supporting continuous improvement initiatives and maintaining inspection readiness. Key Responsibilities Review Manufacturing Batch Production Records to ensure accuracy, completeness, and compliance with cGMP requirements. Review manufacturing forms, supporting documentation, and batch history records associated with product manufacturing. Support the release of API batches and production lots. Perform QA review of batch history records and related quality documentation. Review testing documentation generated by Microbiology and Chemistry laboratories. Review and approve controlled documents related to manufacturing processes, equipment, facilities, and utilities. Investigate discrepancies and assist with deviation, excursion, and quality event documentation. Provide Quality oversight and support to internal stakeholders and external customers. Serve as a Quality representative on cross-functional teams and projects. Identify process, procedure, and system improvement opportunities and recommend solutions. Collaborate with departments to ensure review activities are completed efficiently and in compliance with applicable procedures. Generate and maintain quality metrics to support operational performance and continuous improvement initiatives. Maintain a state of inspection readiness and support regulatory compliance activities. Qualifications & Requirements B.S. degree in Biology, Chemistry, Biomedical Engineering, Chemical Engineering, or a related scientific discipline. 2+ years of experience in the biopharmaceutical, biotechnology, or pharmaceutical industry. Knowledge of current Good Manufacturing Practices (cGMP) and quality systems. Wednesday through Saturday, 1:00 PM to 12:00 AM (four 10-hour shifts per week). This position is not eligible for visa sponsorship or support such as H1B, TN, E-3, CPT, OPT, STEM OPT, or employment-based permanent residence processes, now or in the future. #J-18808-Ljbffr BioTalent

Vacancy posted 1 day ago
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