Senior Quality Specialist

Essential Duties & Responsibilities

The Sr. QA Specialist ensure the quality of products and compliance to internal procedures and external standards.

• Perform review of batch documentation for release of bulk drug substance, 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.
• Provide direction for complex investigations and CAPAs.
• Ensure timely, accurate and complete execution and documentation of quality system events: deviations, investigations and CAPAs.
• Review, develop, and improve quality system procedures / Review and approve CAPAs to prevent recurrence of deviations.
• Review and approve Change Control documentation.
• 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.
• Review and approve master batch records for the timely initiation of manufacturing activities.
• 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.
• Provide training on department specific procedures and systems.
• 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.