Quality Assurance Specialist

Based in Rochester, MN, we are seeking a talented and proactive QA Specialist to join our biotech company's innovative research team. As a QA Specialist, you will play a critical role in advancing our virology-based research and cell engineering efforts to develop cutting-edge viral vectors and cell-based therapies.

Qualifications:
Bachelor’s degree in Quality Assurance or related field
Minimum 5 years of QA experience
Willing to relocate to Rochester
Strong understanding of quality management systems and (GxP), to ensure compliance with regulatory requirements.
Experience with ISO 9001 or other quality management systems
Prefer experience in contract service organization (CRO), Biotech, BioPharma
Experience in change controls, deviations and CAPA investigation


Key Responsibilities:

• Facilitate QA Strategy implementation, delegated GxP inspection readiness efforts, providing Quality Assurance Unit support as described in 21 CFR Part 58, providing metrics tracking and reporting.
• Perform audits on raw data and final reports to assure accuracy and compliance with GxP, study protocols, and laboratory procedures.
• Monitor laboratory quality assurance activities to determine conformance with authorized policies and procedures and with sound practice.
• Review all documentation for adherence to organizational quality standards.
• Ensure that facilities, equipment, organization, processes, and procedures comply with applicable regulations and company standards.
• Provide QA support of change controls, deviations, investigations, CAPA’s and effectiveness checks.
• Develop and maintain compliance-related trending metrics and reports.
• Makes appropriate recommendations for correction and improvement as may be necessary.
• Provide oversight of personnel training record management.
• Provide QA support of internal and external audits, as assigned.
• Reviews and updates Quality Assurance procedures.
• Maintains audit forms and QA records.