Quality Assurance Manager

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 **5+ years of QA Management experienceFermentation/bioprocesses experienceRegulatory auditing experience** $80k-$90k (depending on experience)***** 1st shift w/ flexibilityType of ***** Direct HireLocation: Onsite- South Bend, INAt this time, Astrix cannot transfer nor sponsor a work Visa for this position.Benefits ***** Medical/vision/ dental coverage!Health Savings, FSA, Life Insurance, Pet Insurance, etc.401k and great PTO policy!QA Manager Daily Tasks: What you will **Responsible for leading a team of QA personnelExperience 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/**B.S. Science or Engineering5+ years of QA Management experienceBiology/Chemistry backgroundWe strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

Created: 2025-03-03