- Greendale, Indiana, United States
- On-site
- Full-time · Manager
- 7+ years
Lead the Quality and Compliance functions at the Catalent Greendale site, overseeing a team of Quality Assurance Supervisors and Specialists and ensuring compliance with industry standards and regulations.
Responsibilities
- Oversee Quality and Compliance functions related to dietary supplement manufacturing
- Lead a team of Quality Assurance Supervisors and Specialists
- Review and approve manufacturing and packaging change controls, product formulations, label changes, deviations, corrective and preventive action plans, and customer complaints
- Ensure compliance with FDA, NSF, and SQF requirements and participate in internal and external audits
- Develop and maintain quality and compliance policies, procedures, and guidelines
Requirements
- Bachelor’s degree in science or related field (Chemistry, Microbiology, or Biology)
- Nice to have: Investigation writing
- Nice to have: Regulations 21 CFR 111, 21 CFR 117, 21 CFR 211
- Nice to have: GFSI
- Nice to have: HACCP