Qa Specialist Ii - Ops

About the role

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. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Title: QA Specialist I. Location: Bedford, New Hampshire. Department: Quality Assurance. Reporting To: QA Supervisor, External QA. Responsible For (Staff): No. The QA Specialist will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future.

Responsibilities

• 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 batch 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, and CAPAs
• Review, develop, and approve 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 participates 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 representative to cross functional project teams such as tech transfer, process validation, and process improvement
• 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
• Initi