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