Description
You will provide operational quality oversight at a United States manufacturing site. You will work closely with production, laboratories, engineering and quality teams to keep processes compliant, safe, and reliable.
Responsibilities:
- Ensure GMP processes and personnel adhere to current GMP and regulatory requirements
- Maintain shopfloor oversight and be the first line of contact for quality issues
- Provide guidance during GMP activities to detect potential quality issues
- Perform spot-checks of activities across production and laboratory areas
- Review and approve batch records and documentation
- Provide review and approval of deviations and CAPA plans
- Ensure all GMPs, validation, quality, safety and environmental regulations are met
- Coach employees on the importance of following procedures
- Provide on-the-floor quality oversight and detect early quality risks
- Make or recommend disposition decisions and support lot release activities
Basic Qualifications:
- Bachelor’s degree in biology, chemical engineering, life sciences field or equivalent
- 2+ years of experience in regulated industry with strong quality assurance background
- 1+ years of experience with GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements
- Experience with validation principles, aseptic processing, quality systems and FDA regulations
Preferred Qualifications:
- Experience in biologics or pharmaceutical manufacturing environments
- Training or experience in root cause analysis methods such as DMAIC
- Familiarity with inspection readiness and regulatory agency expectations