Quality Assurance Director – FILLED

Quality Assurance Director; The Wellington Group has been engaged to find an experienced QA Director with experience leading and managing a staff and internal programs focused on Production Inspection(s) and Operational Quality for cGMP manufacturing of FDA regulated products. Put your Quality Leadership in Production Inspection to work in a new job today!

Position Duties:

  • Manages the incoming inspection, in-process inspection, and supplier quality programs
  • Evaluates workload and determines resource requirements, schedules, and test equipment utilization requirements
  • Develops and validates test methods, reviews and approves reports
  • Coordinates and facilitates non-conformance investigations (OOS and CAPA investigations), and notifies management of issues that can impact safety, effectiveness or customer satisfaction
  • Works with Production and Engineering Management to establish and verify critical process parameters for process control of compounding, production and packaging operations
  • Facilitates product life cycle management in evaluating changes to the manufacturing process and product 
  • Provide trend and other management reports to company executives
  • Maintain in-process and receiving inspection test equipment calibration program

The qualified candidate will have:

  • BS Degree in Chemistry or life sciences
  • 5+ years experience in FDA Quality Management; pharmaceutical, medical devices or OTC product manufacturing
  • Experience with FDA regulated products , OTC products is ideal
  • Lean-six sigma background and/or certification is preferable
  • Knowledge of FDA 21CFR211, 21CFR820, ISO and related guidance documents
  • Proven team facilitator – ability to work through and remove road blocks preventing projects from moving forward, ability to guide teams to best solution.
  • Effective decision making and analytical, ability to render sound decisions and recommendations after receiving related data, circumstances, options and consequencesStrong verbal, written, analytical and interpersonal skills
  • Bilingual (Spanish, English) preferred
  • Strong computer skills required with effective use of; ERP and EQA Programs, Minitab, Microsoft Excel, Word, Power Point, and Adobe Acrobat

Industry: Quality Assurance, Quality Management, CAPA, OOS, Deviations, Production Inspection, Manufacturing Quality

Job Code: 448-32-MH2322

Location: New York

Apply directly at: http://www.maxhire.net/cp/?E55F6E361D43515B7D52182B77501A62482D7D

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( https://twgrecruiters.com)   910-338-2795

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