The Associate Quality Assurance (QA) Auditor is an entry level trainee position. Under the training and mentorship of senior department personnel, the Associate QA Auditor will perform audits of protocols, in-life critical phases, raw data and final reports of basic design to assure accuracy and compliance with Good Laboratory Practice Regulations (GLP) and Standard Operating Procedures (SOP) and maintain written and signed records of auditing activities. Additional responsibilities include: obtaining a clear understanding of the Quality Systems and regulatory requirements for the Testing Facility operations; achieving a firm understanding of GLP regulations and site SOP requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES :
Under the training, mentorship and review of senior Quality Assurance personnel, learn and apply the principles of GLP compliance to work assignments including:
- Review protocols for compliance with all pertinent government and international GLP regulations.
- Perform raw data audits for studies to ensure accuracy and compliance with the GLPs, study protocol and Standard Operating Procedures.
- Audit in-life critical phases of ongoing studies for compliance with the GLPs, study protocol and Standard Operating Procedures.
- Review final reports to ensure accuracy and compliance with GLP regulations and the study protocol/amendments; ensure that the final report accurately describes the raw data and study methods.
- Determine and assure that study deviations are appropriately reported and documented.
- Prepare and sign the Quality Assurance Statement to be included with audited final report.
- Prepare and review Quality Assurance files prior to Sponsor site visits; ensure that QA audit files are archived.
- Perform all other related duties as assigned.
- Education: Bachelor’s degree (B.S./B.A.) or equivalent, preferably in a life science or related discipline.
- Experience: Entry level - 0+ year experience.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: N/A
- Other: Knowledge of Microsoft Office ® applications and spreadsheet programs such as Access and Excel. This position requires the individual to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate (written and oral) findings.
Charles River Laboratories is an equal opportunity employer who values diversity in the workplace.
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