Our QA Manager position is a great opportunity to work with a leading Life Sciences company. If your passionate about enhancing global healthcare, this is a great opportunity for you.
We are looking for a sharp professional that possesses these top 3 skills:
- 5+ years of QA Management experience
- Fermentation/bioprocesses experience
- Regulatory auditing experience
Pay: $80k-$95k (depending on experience)
Schedule: 1st shift w/ flexibility
Type of Job: Direct Hire
Location: Onsite- South Bend, IN
At this time, Astrix cannot transfer nor sponsor a work Visa for this position.
Benefits Offered:
- Medical/vision/ dental coverage.
- Health Savings, FSA, Life Insurance, Pet Insurance, etc.
- 401k and great PTO policy.
QA Manager Daily Tasks: What you will do:
- Responsible for leading a team of QA personnel
- Experience in Risk Management, CAPA execution, and Root Cause Analysis
- Act as lead for external/customer audits.
- Responsible for leading Management Reviews.
- Lead certification audits (TUV SUD, BSI, FDA etc.) and understanding how to respond to findings, etc.
- Perform product release functions.
- Assist in the development of validation protocols.
- Manage communications with the FDA and other regulatory bodies as needed.
QA Manager Qualifications/Requirements:
- B.S. Science or Engineering
- 5+ years of QA Management experience
- Biology/Chemistry background
We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you.