Quality Assurance Officer Pre-clinical Service & Translational Research

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Posted Job Title

Quality Assurance Officer Pre-clinical Service & Translational Research

Job Profile Title

Research Specialist C

Job Description Summary

The Quality Assurance Officer’s activities are critical to ensuring compliance with Good Laboratory Practices (GLP) at the New Bolton Center’s preclinical research labs. The Quality Assurance Officer is responsible for maintaining GLP compliance at the Preclinical Service & Translational Research Core and for continuing GLP compliance development on a contracted basis at the Retinal Disease Studies Facility (RDSF). He/she will be performing audits of the Preclinical Service Core against written study protocols and Standard Operating Procedures (SOP); reviewing SOPs and updating formatting to comply with GLP standards; perform study protocol and final written report reviews; perform facility audits as well as pre-audit inspections; and with input from the laboratory’s Director, use their discretion and independent judgment in providing recommended corrective actions to management and the study directors. He/she coordinates onboarding of pre-vet students entering the program. He/she is responsible for facilitating any on-site inspections (both FDA, sponsor QA, IACUC and USDA.), as well as performing routine vendor qualification inspections or re-qualifications. The QA-officer is also responsible for maintaining the GLP archive of retained study data on-site and must provide guidance and regular training to staff as it relates to GLP and compliance. Position located in Kennett Sq., No public transport available.

Job Description

As the Quality Assurance Officer, you will function as the manager of PSC-CORL’s FDA Good Laboratory Practices (GLP) compliance program. Your role is to provide ongoing support and improvement of PSC-CORL’s quality system by 1) performing inspections and audits against written study protocols and Standard Operating Procedures (SOP); 2) reviewing SOPs and training records to comply with our standards;