QA Engineer – Pharmaceutical
Perrigo Company plc
full-time
Posted on:
Location Type: Hybrid
Location: Allegan • Missouri • 🇺🇸 United States
Visit company websiteJob Level
JuniorMid-Level
About the role
- Support and participate in continuous improvement activities in the operations areas
- Provide primary Quality Assurance review and approval for annual product reviews, deviations, and other cGMP documentation
- Ensure all information and documentation conforms to company policy, cGMP's and all applicable FDA guidelines
- Lead and participate in quality driven initiatives in the continuous support of Quality improvements
- Responsible for reviewing and approving documents such as deviations, Annual product reports, planned deviations, etc.
- Provide initial risk assessment of Quality events
- Work with operations, laboratory, engineering, and maintenance managers and staff to develop, evaluate and implement action plans to maintain or improve product and process quality
Requirements
- Bachelor's Degree in a scientific discipline or closely aligned field
- Minimum of two years experience working in an FDA regulated industry, preferred
- Demonstrated understanding and application of Continuous Improvement and Root Cause analysis skills
- Demonstrated understanding of and ability to apply cGMPs and US FDA laws and requirements in an FDA regulated industry
- Strong functional knowledge of SAP systems
- Demonstrated ability to organize multiple tasks and change priorities to meet project deadlines
Benefits
- Benefits tailored to supporting you and your family
- Career development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality AssurancecGMPRoot Cause analysisrisk assessmentContinuous Improvementdocument reviewdeviation managementproduct quality evaluationprocess quality improvementFDA guidelines
Soft skills
organizational skillsability to prioritizecommunication skillscollaborationleadershipproblem-solvingadaptabilityattention to detailtime managementinitiative