Senior Quality Assurance Representative
$69,200–$110,900 year
On-siteIndianapolis, Indiana, United States
Job Summary
Review executed documentation to verify steps and ensure good documentation practices are followed during manufacturing activities. Perform and document line clearances and room releases, while monitoring formulation and filling processes for cGMP compliance. Act as a Subject Matter Expert for aseptic technique, reinforcing aseptic practices to operators and observing cleaning and disinfection protocols. Document and report observations, GMP violations, unsafe conditions, or unusual results to management. Requires a Bachelor's degree in a life science discipline or equivalent experience, with a Monday through Friday schedule from 8am to 4:30pm.
Required Qualifications
- Bachelors Degree in Biology, Chemistry, or other Life Science Discipline
- 2+ years of GMP pharmaceutical industry experience
- High School Diploma or GED
- 5+ years of GMP pharmaceutical industry experience
- Qualification in aseptic gowning
- Certification as an aseptic processing SME
- Monday - Friday 8am - 4:30pm
- Lift and/or move up to 25 pounds
- Wear appropriate Personal Protective Equipment
Desired Qualifications
- Experience with computer software applications including Microsoft Excel, Word, and Access
- Experience with Quality Management computer systems and SAP
- Experience with EU Annex 1 classified areas A, B, C, and D including acceptable aseptic behaviors, practices, and gowning
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