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Description: Our Client, a pharmaceutical company, is looking to hire a Senior QA Investigations Specialist in Somerset, NJ.

Responsibilities:

Review, coordinate, and assist to ensure nonconformances are adequately investigated for determination of root cause and product impact per FDA regulations;
Ensure 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;
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 the 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.

Requirements:

Experience 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 (8+ years);
Experience with Q&A in pharmaceuticals or related field (5+ years);
Experience in sterile product manufacturing as it relates to Q&A functions such as nonconformances;
Experience performing cGMP related training;
Experience with TrackWise;
Bachelors degree.

Why Apply?

Work with a stable company with a track record of success and growth since 1971;
Benefit from health, vision and dental insurance plans offered to employees;
Become eligible for Premium Plus and Basic Blue Medical Insurance Programs, 401(k) Program, life insurance, short and long-term disability, AD&D;
Enjoy good work / life balance, free lunch and breakfast every Friday, paid vacations and holidays.

If this job is not for you, earn a $2,100.00 referral bonus in cash by referring a Candidate or a Client to us. is one of the most generous on the market!


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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