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

• Must possess strong technical skills. Certification by ASQ, as a CQM/OE is strongly preferred.
• Must have current knowledge of FDA regulations, current Good Manufacturing Practice (cGMP), and Good Documentation Practices (GDP).
• Be able to support change management, and leadership skills are required in order to interface with all levels of management and to coach, train, and motivate technical staff.
• Must be able to communicate clearly, orally and in writing, and exchange information accurately
• Must possess excellent project management skills in order to coordinate multiple projects and adhere to tight timelines while working with people at all levels of the organization.
• Must be self-motivated and possess strong problem-solving and critical thinking skills.
• Must have excellent interpersonal and leadership skills in order to effectively meet objectives.
• Must possess proficient computer skills, including Microsoft Office software (Word, Excel, PowerPoint).

Experience Required

•  Bachelor’s degree in chemistry, biology, microbiology or engineering (can be substituted with additional years of experience at department head’s discretion).
• 3 to 5 years of management experience in a Quality Assurance environment within a CPG or Pharmaceutical industry, contract manufacturing preferred.
• Strong understanding of cGMP and FDA CFR 210/211 requirements.

Physical Requirements

• Regularly sit, stand, and walk for extended periods of time.
• Ability to sit, balance, climb, stand, bend, squat, squeeze, kneel, turn, crouch, stoop repeatedly.
• Physically able to lift 50 pounds periodically.
• Frequent exposure to varying temperatures, loud noises, heavy machinery, fumes, airborne particles, moving mechanical parts, electrical current, chemicals, and vibrations.
• Prolonged use of computer screen.
• Exposure to repetitive motions (making substantial movements/motions of the wrists, hands, and/or fingers).