Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.Participates in developing Standard Operating Procedures to ensure quality objectives are met. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Perform Quality Assurance related production and production related activities
o Issuance of production records, procedures and labels
o Ensure timely assessment and closure of discrepancies, Deviations and Change Controls requests
o Ensure timely assessment and closure of Laboratory Investigations
o Ensure timely assessment and closure of batch and material hold events
o Communicate lot disposition pending issues to Management
o Oversee the packaging and shipping process; authorize shipment.
• Review and disposition disposable raw materials and components for GMP use
• Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the area
• Perform walk-throughs and process observations
• Ensure products are manufactured in compliance with regulatory and GMP guidelines.
• Escalate issues that may adversely impact timely release of product
• Identify compliance risks and escalate the issues to appropriate levels of management for resolution
• Generate and update procedures and forms.