We are seeking a QA Manager to join our North American headquarters in St. Paul, Minnesota.
As QA manager, you will:
• Oversee all quality aspects with the aim of contributing to the organization’s strategy
• Translate strategy into quality in actual projects utilizing generally accepted quality standards (including ISO standards, corporate TQM, GMP, GDP, etc.) to achieve continuous improvement.
• Manage a small QA team
• 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:
• Pharmacy degree preferred, but not required
• Experience working within GMP standards is preferred
• 3+ years of experience in a quality department, ideally working on an international scale
• CAPA and/or root cause analysis experience is ideal
• Experience working and coordinating with analytical testing labs
• Formulation, product release and patient safety experience
• Experience in retail and/or hospital pharmaceutical market
• Knowledge of principles, theories and laws, policies and procedures relating to pharmacy operations
• Experience in managing a team is preferred, but not required
• Technical ability, analytical ability, and decisive judgment
• Self-motivated with a strong work ethic
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.