Quality Assurance Manager

Quality Assurance Manager

Position Summary The Quality Assurance Manager is responsible for the day-to-day functions of the Quality Assurance department to include administration of the electronic Quality Management System (eQMS), Document Control, supporting Internal and External Audits, Document Training, Planned Deviations, document retention, APRs, mock recalls, and Change Management. The ideal candidate will demonstrate technical leadership and provide strong support; develop technical solutions to complex problems that require innovation and creativity; lead projects outside of the usual scope; regularly initiate innovative procedures and make strategic recommendations to improve processes.

Responsibilities and Essential Duties

• Manage the Quality Assurance team to improve and enforce quality standards through quality best practices.
• Ensure highly disciplined compliance with all regulatory standards, systems, and procedures.
• Conduct periodic mock recalls to ensure that the traceability program is functioning properly.
• Ensure cGMPs, Standard Operating Procedures, and all Quality procedures are in place and followed.
• Educate and instruct plant personnel in recommended quality practices.
• Assist in development of special department projects and work in conjunction with other departments and Quality team members.
• Support and develop Quality Training as needed.
• Record of Safety Ensure team maintains highest levels of safety to build an environment where the team's wellbeing is a top priority.
• Support IQ / OQ / PQ and Product validations for OTC production.
• Perform Annual Product Reviews (APRs).
• These responsibilities can and will change as we continue to grow.

Technical Skills Required

Experience Required

Physical Requirements