Quality Assurance Manager

The Quality Manager collaborates closely with cross-functional teams, including Chemistry, Manufacturing, and Controls (CMC), Regulatory Affairs, and Quality Assurance and company’s GMP suppliers, to drive continuous improvement initiatives and maintain a culture of quality excellence.

ROLES & RESPONSIBILITIES:-

• Identify gaps and opportunities to develop further QMS, including writing and implementing SOPs and work instructions.
• Maintain electronic systems for training, document control, supplier audit schedule, and files.
• Review and approve GMP protocols for release and stability testing of company’s combination products, analytical method validation protocols and reports, master and executed batch records, product specifications, etc. Experience with analytical testing of combination nasal spray products is preferred.
• Contribute to out-of-trend and out-of-specification investigations and review executed investigations, ensuring that all documentation, including root causes analysis and applicable CAPAs, are well documented and archived for easy retrieval in Company’s electronic file storage system.

QUALIFICATIONS:-

• Minimum of a B.S. degree or equivalent in chemistry, biochemistry, or similar discipline required; Master’s degree in scientific discipline preferred.
• 5+ years in the Quality Assurance role working with internal GMP manufacturing or external GMP suppliers of drug substances, drug products, labeling and packaging, or a combination of the above. (Required)
• Preferred experience working with combination nasal spray products.
• Have at least 3-5 years of hands-on analytical chemistry in a GMP laboratory such as quality control or analytical development.