Quality Assurance Manager Job at Astrix, South Bend, IN

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  • Astrix
  • South Bend, IN

Job Description

Join our amazing team! We want to help you continue to succeed and grow in the life sciences industry!

Our QA Manager position is a great opportunity to work with a leading Medical company!

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-$90k (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!

Job Tags

Work visa,

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