We are looking for a Quality Assurance Manager to report to the Senior Quality Assurance Manager. This person supervises Document Control, Batch Release, Product Returns, Complaints, and AHPAERs.
Roles and Responsibilities:
- Managing those individuals within the QA department that includes but is not limited to the following responsibilities:
- Document Control
- Product Returns
- Assuring that all applicable cGMP requirements and regulations are met through compliance to government regulations, industry standards and company policies
- Batch record documentation review and approval
- Finished Product, Raw material, and Component release.
- Working with Production, Regulatory Affairs, Marketing, New Product Development and other necessary departments to maintain awareness of Quality Systems and documentation activities.
- Product quality and conformance to government regulations, industry standards, and Company policies.
- Developing and deploying the Quality systems and documentation to ensure products conform to defined requirements.
- Understanding and deploying processes to assure conformance to government regulations, industry standards and Company policies.
- Conducting investigations, assessing and closing deviations, determining impact of the issues that could affect product quality, safety and purity.
- Reviewing customer complaints/AERs to ensure customer satisfaction and potential CAPAs are completed for nonconformance.
- Reviewing of PMs, Pest Control, Calibration records, etc.
- Must be able to effectively communicate with other departments and function within a team environment.
Minimum Requirements: The Quality Assurance Manager must have at least 7-10 years of experience in an FDA regulated manufacturing environment, with 5 years specifically in Quality Assurance and/or Quality Control. Prior FDA or equivalent inspection experience is highly recommended.
Education and Experience: BS Degree or BA Degree with a Science major or concentration and continuing education credits in the pharmaceutical industry through a reputable professional society.