2 openings Somerset, New Jersey Candidates need to have a QC Analytical Chemist background
SUMMARY: The QA Investigations Specialists review, coordinate, and assist to ensure non-conformances are adequately investigated for determination of root cause and product impact per FDA regulations. In addition, the QA Investigations Specialist 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.
ESSENTIAL FUNCTIONS: Initiate, 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. Author QA deviations/investigations 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. Manage CAPAs to ensure timely closure of actions resulting from various types of investigations from the QC laboratories. 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 Other duties as required
QUALIFICATIONS: Bachelor's degree required Minimum of 3 years' experience in Quality Systems relating to deviations, investigations, out of specifications (OOS), non-lab out of specifications, corrective and preventive actions (CAPA), and product complaints. In addition, experience in performing cGMP related training preferred Must exhibit strong organizational, communication, interpersonal skills and attention to detail. Proficient with computer programs. TrackWise experience preferred. Five years of previous quality experience in pharmaceuticals or related field.