Quality Assurance Manager - United States
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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
Set yourself apartYou 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