- Communicate and maintain the Quality Management System
- Conducting daily review of key performance quality metrics
- Releasing “Quarantined” product into good upon the receipt of documentation from QC and Manufacturing
- Notifying Operations Manager and QA Supervisor/Manager of any unusual trends and managing investigation efforts
- Verifying that the system is identifying “released” product accurately
- Work closely with Operations to identify and correct any system or human generated discrepancies inclusive of corrective and preventative action.
- Assist in trending data to look for ways to improve quality processes.
- Guide internal customers in determining root cause of discrepancies and the development of corrective actions
- Make suggestions on quality improvements
- Facilitate change control process when changes are made to Standard Operating Procedures (SOPs) or Work Instructions (CWIs).
- Reviewing final QC Batch Release reports to ensure accuracy
- Creating Certificates of Assurance for products managed by the site
- Manage and administer the site's equipment calibration process
- Manage and administer the site's equipment training process
- Proactively work with site lab owners to develop QMS procedures, ensure compliance to ISO 9001 standards and identify and participate in improvement opportunities.
- Bachelor’s Degree in Science or Engineering
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