Quality Assurance Specialist

A leading organization in the biopharma industry is seeking a QA Specialist to join its team. This role requires a strong background in quality management systems, regulatory compliance, and laboratory quality assurance.

Key Responsibilities:

• Ensure compliance with GxP regulations and quality management systems.

• Conduct change control, deviation management, and CAPA investigations.

• Support GLP lab operations (21 CFR Part 58) and ISO 9001 compliance.

• Perform computerized systems validation and maintain documentation.

Qualifications:

• Bachelor’s degree in Quality Assurance or a related field.

• 5+ years of QA experience in biopharma or GMP settings.

• Experience with GLP labs, ISO 9001, and regulatory compliance.

• Preferred experience in CROs, biotech, or bio-pharma industries.

• Willingness to relocate to Rochester.

This is a direct-hire opportunity offering career growth in a dynamic environment. Apply now to be part of an innovative team!

Click here to apply online