Address
Form of work Quality Assurance Engineer
- Process various documents supporting the Quality Management System (QMS), such as: Non-Conformance (NC) Reports, Corrective and Preventive Actions (CPAs), Deviations/Waivers, Customer Complaints and Quality Alerts.
- Use Root Cause Analysis to investigate and identify the true cause of NC product or processes, audit findings, etc. Based on the root cause, work as a team with various departments to create an action plan to prevent reoccurrence of issues.
- Work with customers for approvals of CPAs, Deviations/Waivers, etc when necessary.
- Conduct document reviews of various controlled documents to ensure processes are accurately being followed and/or need to be updated to reflect the actual process.
- Act as a liaison and knowledge reference between Quality and various departments (i.e. Compounding, Filling, etc), to ensure procedures and specifications of various customers are being followed to produce product right first time.
- Create and implement effective Control Plans for assigned products/processes.
- Generate and/or edit controlled documents to ensure manufacturing processes are being followed in accordance with customer specifications, regulatory requirements, and established validation parameters.
- Assist in conducting Annual Product Reviews (APRs) of regulated/drug products.
- Participant of the Risk Assessment Team.
