Quality Assurance Manager - FDA, GMP
Location
Florence, SC | United States
Job description
Great opportunity to join a global industry leader as the site QA Manager for the SC plant. Will provide direction and team management supporting the QA programs from raw material production, procurement and handling, to manufacturing of the finished products ensuring compliance, meeting specifications, quality, and integrity standards. Requires a comprehensive knowledge of FDA, GMP, SAP, HACCP, and Auditing practices.
- Participate with quality leaders in the development of company-wide quality processes and systems; and interaction with plant management, R&D, Sales/Marketing, and other manufacturing operations.
- Manage and implement the Quality Assurance Release processes and systems. Facilitate continuous improvement throughout the site, including training, communication and reporting.
- Implement and conduct mock recall exercises for the products and plant site. Prepare recall report with all supporting information utilizing SAP.
- Lead the HACCP program including annual reviews. Reviews and documentation are part of the MOC process.
- Responsible for conducting food safety inspections and in-depth internal audits for compliance and reporting the findings to management.
QUALIFICATIONS:
- BS degree in Chemistry, Biology or related science with 7-10 years of Quality Assurance experience in food, pharma, biotech, API plant environments.
- 3+ years QA Leadership experience required
- Knowledge of FDA, GMP compliance
- Experience with SAP systems required.
- HACCP and Auditing certification required.
- Able to work in the USA without sponsorship, now or in the future
Job tags
Salary
