Quality Assurance (QA) Lead- Documentation and Product Release - (Quality)
Englewood Lab, Inc
Totowa, new jersey
Title: Quality Assurance (QA) Lead- Documentation and Product Release
Reports to: Quality Assurance Supervisor or Manager
Department: Quality Assurance
Responsibilities:
- Support Annual Drug and Device History Reviews.
- Oversee and maintain the Quality modules in the ERP system for compliance (Change Controls, Deviations, Discrepant Materials, Returns, Supplier Issues, etc.
- Support Investigations (e.g. non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups).
- Lead the review, release of compliance materials (eg FG, RM, bulk and intermediates as required to support customer requirements). Also maintain accurate record of approved, quarantined, rejected materials and products.
- Support audits, inspections and ensure compliance to all SOPs and other regulatory...