Senior QA Investigations Specialist


Job ID 19-00014

Industry Pharma

Job Type Permanent

Location Somerset, NJ

Description

Description:
Reviews, coordinates, and assists to ensure nonconformances 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. 
 

Responsibilities:

  • Track all Non-Conformance/Deviation records to ensure the timely closure of all records.
  • Follow up with the Assigned To's 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 To's 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
  • 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

Qualifications Bachelor's 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. 



Qualifications

Candidate Details

  • 7+ years' of experience
  • Seniority Level - Mid-Senior
  • Management Experience Required - No
  • Minimum Education - Bachelor's Degree
  • Willingness to Travel – Occasionally
  • Must exhibit strong organizational, communication, interpersonal skills and attention to detail.
  • Proficient with computer programs. TrackWise experience preferred.
  • 5 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.