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-Assist in reviewing, coordinating, and assisting to ensure non-conformances are adequately investigated for determination of root cause and product impact per FDA regulations.
-In addition, ensures that corrective and preventive actions (CAPA) are identified and implemented to prevent/reduce reoccurrence. Oversee product complaint investigation process to ensure they are adequately investigated, within defined timeframes.
-Issue, track, monitor, facilitate closure, and QA review of deviations, investigations, out of specification (OOS), and out of trend (OOT) reports for compliance to FDA regulations and other guides/guidelines.
-Provide cGMP guidance to functional groups such that all discrepancies are closed within defined timeframes.
-Issue reports of all open non-conformances and track completion/closure.
-Review and/or perform investigation of product complaints with various functional groups.
-Manage CAPA program to ensure timely closure of actions resulting from various types of investigations.
-Provide metrics to track/trend non-conformances and recommend additional actions to prevent reoccurrence.
-Assist during regulatory inspections or other audits as required.
-Provide training to function areas on compliance issues.
-Bachelor s degree and a minimum of 5 years experience in Quality Systems relating to deviations, investigations, out-of-specification (OOS), non-lab out-of specifications, corrective and preventative actions (CAPA), and product complaints.
-In addition, experience in performing cGMP related training.
-Proficient with computer programs. TrackWise experience preferred.
-Five years of previous quality experience in pharmaceuticals or related field
Associated topics: crime scene, detective, fingerprint, inspector, investigate, investigation, investigative, investigator

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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