Salary
💰 $85,000 - $100,000 per year
About the role
- Support data analysis and continuous improvement projects related to product and process quality
- Provide Quality Assurance review and approval for annual product reviews
- Support review of deviation investigations, laboratory investigations, and other cGMP documentation and studies at Perrigo New York
- Ensure documentation conforms to company policy, cGMPs, and applicable FDA guidance
- Execute data analysis projects including APR analysis, Ppk improvements, stability assessments, and development of real-time statistical analysis using Minitab Connect
- Participate in quality-driven initiatives and collaborate with operations, laboratory, engineering, and maintenance to develop and implement action plans
- Review and approve deviations, annual product reports, non-routine batch status change requests, CAPA closures, and calibration non-conformances
Requirements
- Bachelor's Degree in a scientific discipline or closely aligned field
- Minimum of two years experience working in an FDA regulated industry
- Demonstrated understanding of and ability to apply cGMPs and US FDA laws and requirements
- Strong functional knowledge of SAP systems
- Demonstrated ability to organize multiple tasks and change priorities to meet project deadlines
- Onsite presence required; no relocation offered for this position