QA/CE Investigations Supervisor


Job ID 19-00070

Industry Pharma

Job Type Permanent

Location Decatur, NJ

Description

Summary:
Maintains and coordinates investigation action plan to assure that all excursions are adequately investigated for determination of root cause and that corrective and preventive actions are identified and implemented to prevent/reduce excursions in processes and procedures. Assists the Manager in the scheduling and coordination of staff to meet aggressive project timelines.
 
Essential Functions:
Using root cause determination techniques, perform Deviation, Nin-Conformance, OOS, OOT, field complaint and event excursion investigations to determine the root cause and effective preventative action implementation to prevent recurrence of the event in TrackWise.
Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.
Work with cross-functional teams to develop and track CAPA plans.
Working with operations personnel in performance of effective investigations.
Evaluate trends of investigations and CAPA's to identify major areas of opportunity for improvement.
Able to trouble shoot quality assurance complain, CAPA, and investigation issues in consultation with subject matter experts and management.
Previews and reviews completed Maintenance Work Orders as part of the Quality Assurance audit function.
Supervise team on projects
Evaluate and incorporate training programs to enhance root cause training and investigation writing
 
Additional Responsibilities:
Ability to work effectively as a team and independently.
Proficient at Microsoft Outlook, Excel, and Word.
Strong communication skills and presentation skills
Ability to abide by quality standards.



Qualifications

Education and Experience:
Bachelor of Science in a Quality / Process related field or equivalent experience
2 years of root cause analysis experience in a manufacturing, packaging, engineering, and distribution environment, preferably pharmaceutical of FDA regulated operation
Prior knowledge of Track Wise system is a plus
 
Requirements include:
Ability to hear accurately the spoken word with moderate office noise or plant noise.
Ability to apply deductive reasoning and understand complicated issues.
Ability to receive instructions and follow work rules and company policies.
Ability to follow safety and security practices.
Ability to meet deadlines and effectively deal with office stress.
Ability to accurately communicate ideas, facts, and technical information.
Maintain confidentiality of certain information.
 
Work Environment:
Pharmaceutical, sterile cleanroom requiring special gowning.
Exposure to equipment use and maintenance / calibration for sterilization, depyrogenation, washing, filling, packaging, etc. pharmaceutical products.
Manual and high speed packaging operations.
Pick and packaging of pharmaceutical products for commercial distribution.
 
Candidate Details:
2+ to 5 years' experience
Seniority Level - Mid-Senior
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionally