Position located in Rochester, MN

Responsibilities of the Quality Assurance Specialist:

• 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.
• Develop and maintain compliance-related trending metrics and reports.
• Provide recommendations for necessary corrections and improvements to quality processes…
• Provide oversight of personnel training record management.
• Provide QA support of internal and external audits, as assigned.
• Review and update Quality Assurance procedures.
• Maintain audit forms and QA records.

Requirements of the Quality Assurance Specialist:

• Bachelor’s degree in quality assurance or science-related field.
• Minimum of 5 years in GxP or equivalent regulatory environment.
• Excellent knowledge of GLP and GCP requirements.
• Experience with reviewing laboratory data and computer validated data collection systems in a preclinical and clinical environment.
• Able to understand published methodology to audit existing test methods and ensure accuracy.
• Thorough understanding of governing regulations and pertinent scientific literature to ensure compliance.
• Experience performing quality process audits and review of deviations and CAPA.