We are seeking a QA Specialist to join our team in the biopharma industry. This full-time, onsite role is based in Rochester, MN, and is ideal for someone with strong industry experience and a deep understanding of quality systems in a regulated environment.
Key Responsibilities:
- Ensure compliance with GxP regulations and internal quality management systems.
- Support and maintain ISO 9001 and other quality standards.
- Conduct and support change controls, deviations, and CAPA investigations.
- Participate in software/computerized systems validation.
- Contribute to audit readiness and regulatory inspections.
- Collaborate with cross-functional teams to promote a culture of quality.
Qualifications:
- Bachelor's degree in Quality Assurance or a related field (Required).
- Minimum of 5 years of QA experience in Biopharma, GMP, or related industry (Required).
- Willingness to relocate to Rochester, MN (Relocation assistance provided).
- Strong working knowledge of GLP (21 CFR Part 58), ISO 9001, and quality compliance frameworks.
- Prior experience in a CRO, Biotech, or BioPharma environment is preferred.
- Experience with computerized system/software validation is a plus.
Why Join Us?
️ Stable, full-time opportunity in a growing organization.
️ Competitive compensation with relocation support.
️ Work in a collaborative and compliance-focused environment.
About Rochester, MN:
Rochester, Minnesota, is renowned for its scenic beauty, vibrant arts scene, and as the home of the world-famous Mayo Clinic. The city offers a blend of urban and natural amenities, including extensive parks, diverse dining options, and a strong sense of community. With a population of approximately 121,395, Rochester combines the charm of a smaller city with the opportunities of a larger metropolitan area.