Role OverviewThe QA Specialist – Batch Review will support major QA programs, champion and develop the organization’s Quality Mindset, and provide support with identifying and closing Operational and Quality gaps. They will work closely with the QA Supervisor and provide support with client access and review of Batch Records.
What You Will Do
The QA Specialist – Batch Review will perform full lifecycle review and disposition of parenteral manufacturing Batch Records, provide training to QA Associates and Specialists, and create and report batch release metrics to site leadership.
Why It Might Be a Fit
The ideal candidate will have excellent interpersonal skills, written and oral communication skills, and the ability to influence positive outcomes without direct reporting authority. They will also have experience working in a GMP environment and with aseptic processing in cleanroom and/or isolator environments.
Requirements
- Bachelor’s Degree in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
- 4 years minimum experience working in a GMP environment
- 2 years minimum experience working with aseptic processing in cleanroom and/or isolator environments
- Excellent written and verbal communication skills
- General computer skills evidenced by hands-on work with computerized Operations equipment and reporting and data analysis software
Benefits
- Smoke-free campus
- Equal Opportunity Employer
- Prohibits discrimination and harassment of any kind
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