Fagron Services is looking for a highly motivated Quality Assurance Supervisor to lead our Quality Affairs team. You will build, develop, coach and lead the quality team while ensuring all processes and procedures are followed to maximize superior quality in all of our products.
- Translate business strategy into quality in actual projects utilizing generally accepted quality standards (including ISO standards, corporate TQM, GMP, GDP, etc.) to achieve continuous improvement.
- Guarantee quality within the complete flow from raw material to product and continuously strive to achieve optimum quality.
- Assure adequate control and documentation of controlled substances, per state and DEA regulations.
- Follow all federal, state and local laws, rules and regulations for quality and safety in the preparation compounded medications
- Interact regularly with federal and state agencies (FDA and DEA primarily) and serve as the contact for suppliers, customers and local authorities on the subject of quality.
- Manage and process complaints (CAPA)
- Draft and review validation protocols
- Draft and review SOP’s and other elements of the quality system
- Analyze and report on the results of quality controls, and prepare, manage and follow up on audits
You possess the following qualifications, background and abilities:
- BS/BA degree in science or related field required,
- 3+ years in Quality Affairs required; 2+ years in a supervisory or managerial capacity required
- Experience in Pharmaceutical or Food industry with a sound familiarity with cGMP and FDA regulations is required
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.