Sr. Qa Specialist - Ops

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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Sr. QA Specialist - Team Lead will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. The role supports and provides quality oversight client facing QA Operations including Batch Record Review, Lot Disposition, Investigations, CAPAs and Quality System review. The Sr. QA Specialist - Team Lead will also manage oversight of the QA staff and be able to provide feedback and development to enhance team capability.

In this role, the opportunity exists to shape and transform GxP programs by providing QA expertise and guidance to the manufacture of both clinical and commercial products.

• Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
• Review and approve master batch records for the timely initiation of GxP manufacturing activities
• Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
• Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance
• Provide direction for complex investigations and CAPAs
• Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs
• Review, develop, and improve quality system procedures, specifications, and test methods
• Review and approve CAPAs to prevent recurrence of deviations
• Review and approve Change Control documentation
• Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participate in the management review process
• Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner.
• Monitor, identify and propose quality process and system improvements. Lead improvement projects and communicate status to management
• Serve as QA Team Lead to provide quality oversight of manufacturing day-to-day operations, including oversight of QA Team workload prioritization and deliverables.
• Serve as QA lead to cross functional project teams such as tech transfer, process validation, and process improvement
• Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
• Coordinate change control review meetings
• Monitor status of change controls and facilitate the approval process
• Perform risk assessments to comply with internal procedures and external guidelines
• Provide training on department specific procedures and systems
• Interface with clients to address any documentation and compliance concerns
• Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable
• Ensures site readiness for regulatory inspections

• 7-9 years of pharmaceutical or biotech industry
• 4+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
• Bachelor's Degree in a relevant scientific discipline preferred
• Experience performing RCA, technical writing, and working with quality related investigations
• Knowledge of laboratory and production equipment and IQ/OQ/PQ
• Knowledge of FDA…