Responsible for ensuring that the quality of products being manufactured meet the prescribed quality levels. Performs Quality Assurance activities including review of manufacturing and quality inspection documentation.
Essential Duties and Responsibilities
- Monitors the quality system including records and results from processes and procedures to ensure product Quality and compliance.
- Ensuring manufacturing and quality documentation is accurate, maintained, and reflects GMP, procedural and regulatory requirements.
- Inspect and test processes and procedures – take measurements and compare to a predefined standard.
- Ensures operations has approved materials and released
- Coordinate investigations of quality issues as required.
- Accurately document results of inspections and tests.
- Support and coordinate Quality Operations functions for batch record issuance, personnel and material flow, and batch release.
- Review Standard Operating Procedures (SOPs) for manufacturing processes.
- Leads continuous improvement objectives to assure compliance with regulations.
- Develops and/or maintains metrics and trending reports for compliance related activities.
- Supports internal audits and regulatory inspections.
- Train production team on quality procedures, protocols, and documentation as needed.
- Other related duties as assigned.