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.
• 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.
• Other duties as needed.

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.
• Working knowledge of ISO 9001, ISO 17025, and ISO 17034.
• 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.
• Solid working knowledge of Microsoft Office software (e.g., Excel, Word, PowerPoint).
• Possess excellent time and project management skills, being able to manage and prioritize multiple tasks under strict deadlines with minimal supervision.
• Possess excellent interpersonal skills, being able to consult and work with multi-disciplined teams.
• Possess excellent verbal and written communication skills, including the ability to understand and verify scientific text and data.
• Background in molecular biology, virology and/or serology is a plus.
• Contract research organization (CRO) experience is a plus.
• Experience with eQMS (Qualio) is a plus.