Quality Assurance Specialist

This position is responsible for providing QA oversight and auditing activities related to clinical and preclinical studies.

Examples of activities within the scope of oversight and auditing include but is not limited to : preclinical animal studies, sample analysis from clinical and preclinical studies, qualification and / or validation of methods, equipment / software validation, laboratory processes, etc.

Studies may be performed in-house or at a contract research facility. This role will assure corporate compliance with applicable GCP, GLP, GCLP national, international, and state regulations and guidelines. This position will be reported to the Quality Assurance Manager (GCP / GLP).

Responsibilities & Accountabilities :

• Assess and assure study, project, and process compliance with protocols, controlled documents, and applicable regulations and guidelines through audits of company's laboratories, vivarium, vendors and CROs.
• Audit systems, studies, processes, reports, records, and data for accuracy and compliance with applicable regulations. Follow up on any audit findings.
• Perform in-process inspections of nonclinical study phases and assay methods.
• Review study events, deviations, investigations, and change control documentation to assess acceptability of content and documentation.
• Detect Quality Issues and assist Quality Assurance Management with corrective and preventative action process.
• Participate in improvement initiatives intended to improve quality, study compliance, processes, study data, and reports.
• Based on knowledge of regulations, guidelines and relevant SOPs, support staff by acting as a technical resource for compliance related issues.
• Contribute to the development, implementation, and maintenance of SOPs.
• Support the coordination and management of regulatory agency inspections, parent company audits, etc.
• Participate in the vendor qualification program to ensure Sponsor Oversight of vendors.
• Participate in meetings as a quality lead, as requested.
• Other duties, as assigned by Quality Assurance Management.
• Occasional light travel may be expected to perform audits (~10%).

Education / Qualifications :

Experience, skills, and characteristics :