QA Investigations Specialist- Somerset NJ 08873 Temporary position
SUMMARY: Reviews, coordinates, and assists 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.
ESSENTIAL FUNCTIONS: Include the following. Other duties may be assigned. Track all Non-Conformance/Deviation records to ensure the timely closure of all records. Follow up with the Assigned Tos as needed for status and to ensure support is available to ensure completion by the due date. Provide SME support on the use of TrackWise workflows to end users as needed. Provide guidance to Assigned Tos of investigations on performing investigations and in the use of Root Cause Analysis Tools. Provide guidance and training to other personnel/new hires in the Investigation/CAPA group. Manage CAPAs to ensure timely closure of actions resulting from various types of investigations. Provide metrics as requested to track/trend Non-Conformances, Deviations, and CAPAs. Act as the Investigation Team Lead for Non-Conformance/Deviations investigations as needed. Perform the closure of Effectiveness Checks. Manage the Effective Checks to ensure they are completed by the required due date.
ADDITIONAL RESPONSIBILITIES: Assist during regulatory inspections or other audits as required Provide training to function areas on compliance issues Provide training on the use of TrackWise, on performing investigation, and performing root cause analysis as needed. Other duties as required
EDUCATION AND EXPERIENCE: Bachelors degree and a minimum of 8 years experience (preferably sterile products) in a 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.
JOB PREREQUISITES: Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines. 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. Preferred experience in sterile product manufacturing as it relates to QA functions such as nonconformances.
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* 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.