Corporate Quality, Auditor - GLP Quality Assurance

Corporate Quality, Auditor - Memphis, TNKelly Scientific Resources is currently seeking a Corporate Quality Auditor in Memphis, TN. The candidate will be responsible for performing internal GLP and related method validation audits as well as assisting in or performing other external QA activities.Core Responsibilities: * Perform quality system audits as they pertain to GLP regulations and guidance * Internal Study Audits * Conduct reviews of validation study protocols and amendments and bio-analytical dose solution and sample analysis test plans and amendments * Conduct in-process audits on critical phases of the studies conducted* Perform audits on the data and documentation for the studies conducted (LC/MS, HPLC & PCR) * Conduct reviews of draft and final reports * Issue QA statements for all studies * Conduct closeout meetings with respective study director/principal investigator after each audit* External Study Audits * Perform GLP vendor site qualification audits * Prepare written reports, and evaluate corrective actions the observations noted* Perform follow-up visits and periodic routine re-inspections of contract laboratories, as needed* Review study protocols and amendments. * Review draft final reports. * Issue a Conformance statement for these studies. * Internal System Audits * Generate written reports for each audit and when necessary, conduct follow up audits * Partner with functional areas to develop, maintain and approve standard operating procedures * Maintain Validation and GLP study Master Schedules * Review IND submissions (safety) * Review equipment IQ, OQ and PQ(s) and approve equipment for use * Oversee and manage the Corporate Quality Training program* Work with functional management on development of Individual Training Plans (ITP) for the respective areas based on job function * Oversee and manage the Corporate Quality Document system * Notifying appropriate functional management when policies and procedures are due for review * Issuing deviation, laboratory investigations and change control report numbers Qualifications:* Associates degree in scientific field with 2 to 5 years of experience in FDA regulated environment or BS in scientific fieldFor immediate consideration, click the 'Apply Now!' button, or refer a friend by clicking the 'E-mail this job' link provided.Kelly Scientific Resources® has grown into a $200 million global business as the scientific business unit of Kelly Services. Our staff of scientists provides scientific staffing to a broad spectrum of industries including: chemical, cosmetics, food science pharmaceutical, biomedical, consumer products, environmental, medical device, clinical, petrochemical, and clinical research. Learn more about company