QA Investigations Specialist, 3rd Shift


Job ID 18-00019

Industry Pharma

Job Type Permanent

Location Somerset, NJ

Description

Summary:
Reviews, coordinates, and assists to ensure nonconformance's 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.
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



Qualifications

Education and Experience:
Bachelor's degree and a minimum of 5 years' 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.  In addition, experience in performing cGMP related training. 

 

Candidate Details:
5+ to 7 years' experience
Seniority Level - Associate
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Never