Associate Director, Quality Technical Support Job

Employer
Merck
Location
Elkhorn, NE, US
Posted
October 12 2017
Discipline
Other
Organization Type
Pharma
Requisition ID: QUA006278

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.



Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. 


 


The Associate Director, Quality Technical Support is based at Merck's Animal Health facility in Elkhorn, Nebraska.  The Associate Director role will have regional responsibilities for USDA licensed facilities within the United States and Internationally that manufacture large molecule vaccines.




• Author and review technical reports/position papers in support of batch disposition and root cause investigations resulting from process or analytical events that may impact product supply.
• Support the comprehensive process to perform a product assessment in order to identify opportunities to reduce and prevent compliance risks associated with validation/qualification, equipment, facilities, utilities, consistency and controls in production and laboratory operations.
• Provide support to USDA licensed sites during regulatory inspections as necessary and participate in development of responses to resulting action points, and submission of responses to the appropriate regulatory agency, specific focus on the USDA.
• Engage with Quality, Regulatory and Manufacturing teams to support technical quality remediation priorities.
• Provide analysis of field data for USDA/CVB requested product reports and contract manufacturers.
• Represent regional Quality on interdisciplinary teams and demonstrates working knowledge of regulatory guidelines and technical knowledge on projects, such as product transfer projects.



Qualifications

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 




Education Minimum Requirement:




  •  B.S. in relevant field of study

Required Experience and Skills: 



  • 10 years of experience in veterinary vaccine Quality, Regulatory Affairs, Manufacturing, R&E or Process Development

  • Experience Technical Writing

  • Strong Oral Communication Skills

  • Documentation Skills

  • Experience in Root Cause Analysis

Preferred Experience and Skills:




  • Experience in project management


  • Working knowledge of US regulations for the USDA, Ag/SAS, and/or FDA


  • Understanding of EU guidelines


  • Working knowledge of Microsoft Office with a focus on WORD, EXCEL and PowerPoint

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    If you need an accommodation for the application process please email us at staffingaadar@merck.com.


      


    Search Firm Representatives Please Read Carefully: 


    Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.


     


    Visa sponsorship is not available for this position.


     


    For more information about personal rights under Equal Employment Opportunity, visit:


     


                EEOC Poster


                EEOC GINA Supplement 


     


    AHMMD2017



    Job: Quality Operations
    Other Locations:
    Employee Status: Regular
    Travel: Yes, 20 % of the Time
    Number of Openings:
    Shift (if applicable):
    Hazardous Materials:
    Company Trade Name: Merck

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