QA Specialist I - Operations

As a QA Specialist I - Operations, you will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. The role involves batch record review, lot disposition, and quality system review, as well as evaluating deviation incidences and determining which warrant escalation to an investigation.

Requirements

• Perform review of batch documentation for release of internal and external clinical products/commercial products
• Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
• 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
• 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
• 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
• Ensures site readiness for regulatory inspections