Qa Specialist Ii - Ops

We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. The QA Specialist II will work with other departments to ensure the quality of products and compliance to internal procedures and external standards.

Requirements

• 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
• 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
• 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 representative 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
• 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

Benefits

• Life-changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
• We are PCI.
• Our investment is in People who make an impact, drive progress and create a better tomorrow.
• We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow.