Job Title: Quality Assurance Specialist II
Duration: 12 Months
Location: Research Triangle Park, NC, 27709

Job Description:

• This position is responsible for providing QA oversight and auditing of 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 report 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 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:

• Bachelor's degree, in a health care or relevant scientific field and 3+ years of relevant industry experience.
• Knowledge of industry best practices and regulatory requirements (Good Clinical Laboratory Practice, Good Laboratory Practice, a solid understanding of 21 CFR Part 11, and laboratory standards relevant to clinical and preclinical laboratory research).
• Knowledge of GCPs a plus.