Quality Assurance Supervisor 3rd shift
Hours: Sunday - Thursday 11:15pm - 7:15am (Training would take place on 1st shift)
About the role
We are seeking a Quality Assurance Supervisor to oversee quality operations on our 3rd shift manufacturing team. This individual will play a critical role in ensuring compliance with FDA regulations, internal quality systems, and manufacturing standards while driving continuous improvement initiatives across the organization. The ideal candidate is a hands-on quality professional with strong leadership capabilities who thrives in a fast-paced manufacturing environment. This role requires someone who can effectively manage quality processes, mentor employees, enforce compliance standards, and foster a culture of accountability and continuous improvement.
Responsibilities
- Supervise and support Quality Assurance personnel during 3rd shift operations
- Ensure compliance with FDA regulations, cGMP requirements, company policies, and internal quality standards
- Review and approve quality documentation, including batch records, deviations, non-conformances, and corrective actions
- Partner closely with Manufacturing, Operations, and other cross-functional teams to resolve quality-related issues
- Lead investigations related to deviations, non-conformances, and process exceptions
- Monitor production activities to ensure adherence to established procedures and quality requirements
- Drive continuous improvement initiatives focused on quality systems, compliance, efficiency, and employee engagement
- Coach, mentor, and develop team members through performance management, training, and ongoing feedback
- Address employee performance concerns, provide conflict resolution, and ensure compliance with company policies
- Support internal and external audits, inspections, and regulatory activities as needed
- Identify opportunities to strengthen quality systems and improve operational effectiveness
- Ensure SOPs remain current, accurate, and compliant with applicable regulations
Requirements
- 4-5+ years of experience within an FDA-regulated manufacturing or production environment
- Minimum of 3 years of Quality Assurance experience
- Experience reviewing and managing:
- SOPs
- Batch records
- Deviations
- Non-conformances
- Quality documentation
- Working knowledge of:
- FDA regulations
- cGMP requirements
- ISO standards
- Lean Manufacturing Principles
- Demonstrated success leading teams in a manufacturing or quality environment
- Experience managing employee performance, accountability, conflict resolution, and policy compliance
- Strong problem-solving, communication, and organizational skills
- Ability to make sound decisions in a dynamic manufacturing environment
Preferred Qualifications
- Experience within the dietary supplement, nutraceutical, food, pharmaceutical, or related regulated manufacturing industries
- Previous supervisory or people leadership experience
- Experience driving process improvement initiatives and fostering a continuous improvement culture
- Familiarity with CAPA programs, audit support, and quality investigations
Education
Associate degree or bachelor's Degree in a scientific discipline preferred, including:
- Biology
- Chemistry
- Microbiology
- Food Science
- Biotechnology