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The Sr. Specialist, QA-OTF provides Quality Assurance support for GMP Manufacturing, focusing on oversight of master/working cell banks and biological products. Key responsibilities include quality floor oversight, documentation review, conducting visual inspections, performing audits, and implementing continuous improvement initiatives. This position requires collaboration with manufacturing teams and compliance with regulatory standards.

The Senior Analyst, QA is responsible for conducting investigations into critical deviations in manufacturing processes, addressing customer complaints, and collaborating with various departments to identify root causes and implement corrective actions to prevent future occurrences. They create comprehensive reports detailing their findings and work closely with operations and quality assurance teams.

The Lead Specialist, Client QA oversees QA support and management for Client Projects in GMP manufacturing. Responsibilities include documenting quality metrics, collaborating with clients during manufacturing campaigns, reviewing technical documents, and supporting investigations and CAPAs.

The Scientist, QC Analytical is accountable for performing assays and analytical testing to support GMP manufacturing for clinical and commercial clients, generating documents, and providing data interpretation and support for QC method services.

The Manager, Sterility Assurance oversees quality assurance for Aseptic Processing, Environmental Monitoring, and microbial control in Gene Therapy Drug operations. Responsibilities include developing policies, maintaining sterility assurance, leading the Sterility Assurance Council, and ensuring compliance with aseptic processing regulations.

The Principal Representative, QA will implement and maintain the Data Integrity program, manage System and Validation Lifecycle Documentation, and ensure compliance with GxP standards. Responsibilities include reviewing validation documents and SOPs, performing data integrity assessments, and participating in audit trail reviews.

The Senior QC Scientist, QC Moda Administrator is responsible for technical support, administration, training, and maintenance of the MODA application. They manage data for the QC EM department, support internal and external projects, and provide training to end users. The role also involves communication with Quality Instrumentation Manager, conducting periodic reviews, and driving improvements in the MODA process.