Supervisor, Investigations (Bridgewater)

Compensation

: $87,240.00 - $146,790.00 /year *

Employment Type

: Full-Time

Industry

: Non-Executive Management



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You are invited to the Akorn Job Fair: Friday, December 6th, 2019 at the Somerset NJ Doubletree Hotel. Please RSVP to ...@akorn.com.

The Investigations Supervisor will be responsible for supervising the Investigations Team, which includes follow-up of investigator priorities to ensure timely closure of deviations to achieve departmental and business goals. Perform quality approval of minor investigations. Perform investigations as required into non-conformances to assist with maintaining compliance to the deviation closure time-frame delineated within internal procedures.


ESSENTIAL FUNCTIONS:

  • Supervise QA Investigators.
  • Perform review and approval of minor investigations.
  • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.
  • Provide timely updates to Management on the status of open investigations.
  • Using root cause determination techniques, perform Deviation, Non-Conformance, OOS, and OOT investigations.
  • Identify critical quality issues, escalate through appropriate quality systems and assist in the review and determination of the acceptability of deviation reports and proposed corrective action plans.
  • Work with cross functional personnel in the performance of effective investigations.
  • Evaluate trends of investigations and CAPAs to identify major areas of opportunity for improvement.
  • Participate in cross-functional teams to identify effective corrective and preventative actions to improve process quality.
  • Provide training to the QA Investigators on new systems and procedures.
  • Assign daily work assignments to the Investigations Team.
  • Provide Trackwise training to all new Trackwise users.
  • Compile monthly metrics for Non-Conformances and Deviations.
  • Provide support for Adverse Event and Product Complaint Investigations.
  • Qualifications

  • Bachelor of Science in a Science/Engineering related field or equivalent experience in a Quality System relating to deviations, investigations, out of specifications (OOS), non-lab out of specifications, corrective and preventive actions (CAPA), and product complaints.
  • Two years (2) of team lead or supervisory experience is required.
  • Proficiency in Track Wise is a plus.
  • Eight (8) years of root cause analysis experience in a manufacturing, packaging, engineering, and distribution environment, preferably pharmaceutical FDA regulated operation.
  • Prior experience working in an aseptic manufacturing environment is required.
  • You are invited to the Akorn Job Fair: Friday, December 6th, 2019 at the Somerset NJ Doubletree Hotel. Please RSVP to ...@akorn.com.
    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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