Position located in Rochester, MN

We are a dynamic and growing biotech company dedicated to improving patient lives through innovative solutions in genetic, viral, and cell-based therapies. We are seeking an experienced QA Specialist to assist the team during the expansion of our company. The right candidate will have CLIA and GxP experience, and come from a biopharmaceutical, medical device, or GMP manufacturing background.

Responsibilities of the Quality Assurance Specialist:

• Implement quality assurance strategies and ensure preparation for GxP inspections.
• Provide Quality Assurance Unit support in compliance with relevant regulations (e.g., 21 CFR Part 58).
• Track and report quality metrics to monitor performance and identify areas for improvement.
• Audit raw data and final reports for accuracy and adherence to GxP study protocols and laboratory procedures.
• Monitor laboratory quality assurance activities to ensure compliance with established policies, procedures and industry best practices.
• Ensure that facilities, equipment, processes and procedures comply with applicable regulations and company standards.
• Support change controls, deviations, investigations, corrective and preventative actions (CAPAs) and effectiveness checks.
• Develop and maintain compliance-related trending metrics and reports.
• Recommend corrective actions and improvements to enhance quality and compliance.
• Oversee personnel training record management.
• Review and update Quality Assurance procedures.
• Maintain audit forms and QA records.

Requirements of the Quality Assurance Specialist:

• BS with 5+years of QA experience in a GxP, GLP or GMP environment.
• Strong understanding of GLP and GCP requirements.
• Working knowledge of ISO 9001 standards and 21 CFR Part 58 regulations.
• Experience reviewing laboratory data and working with computer validated data collection systems in preclinical and clinical settings.
• Ability to understand and audit existing methods to ensure accuracy.
• Thorough understanding of governing regulations and relevant scientific literature.
• Experience conducting quality process audits, reviewing deviations and managing CAPAs.
• Strong interpersonal skills and the ability to collaborate effectively with multidisciplinary teams.
• Open to relocating in a 30-minute radius of Rochester, MN.

Preferred Qualifications of the Quality Assurance Specialist:

• Experience working in a contract research organization (CRO).
• Familiarity with electronic quality management systems (eQMS).