Quality Assurance Manager

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!