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Associate Director, Quality Systems - Boise, United States - Idaho State Job Bank
Description
Associate Director, Quality Systems & Compliance at Merck in Boise, Idaho, United States Job Description Job Description Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.
Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Position Responsibilities:
+ The Associate Director is responsible for performing comprehensive and detailed GMP compliance audits of human health sites, animal health sites, contractors, business partners, and suppliers. + Support new business opportunities through the performance of due diligence, pre-contract, and Pre-PAI audits. + Responsible for accepting audit assignments, performing audit pre-work, conducting audits, and write-up of audit reports within defined timeframes. + Maintain an understanding our company policies, procedures, and guidelines. + Maintain awareness of evolving industry and regulatory trends/regulations. + Obtain and maintaining auditor qualification through on-going training and continuing education programs to enable the performance of successful audits + Coordinate with Site Quality leads on audit refusals and postponements.
Required Experience and Skills:
+ Must possess 'Subject Matter Expertise', including knowledge and demonstrated application in one or more of the following areas: Medical Device/Combination products, Biologics, Vaccines, API's, Non-sterile Drug Products, or Sterile Drug Product manufacturing. Biologics auditing experience is required. + Thorough understanding of Quality Management Systems and process to support the manufacturing of drug sub To view full details and how to apply, please login or create a Job Seeker account