Senior Specialist Quality Assurance –IT Systems

Madison, NJ, US
May 08 2018
Organization Type
Requisition ID: REG003510

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.
The Senior Specialist is responsible for ensuring a current, compliant and efficient quality management system for Merck Animal Health IT systems in the US and EU.  This person will also be required to continuously pursue system improvements to optimize IT QA processes in accordance with current laws and guidelines.
Major Activities and Responsibilities:
  • Provide QA support for the GxP computerized systems to ensure the maintenance of compliance of the IT GxP Quality Program.
  • Perform critical review of computer system validations and equipment qualifications in reference to internal and external standards. Provide support for planning, coordination, performance and documentation of both internal and external audits in line with appropriate requirements.
  • Administer and maintain QA related electronic systems (Sharepoint, EDMS, and training systems). 
  • Maintain an efficient document management system for controlled documents.  Maintain documentation of QA tasks in compliance with associated requirements and internal SOPs.
  • Provide support for global QA initiatives and keep current on IT QA trends globally.
  • Communicate across R&D QA team and foster a productive and efficient team environment. 

  • Bachelor of Science degree (minimum) in science, engineering, or other relevant field (advanced  degree preferred).  
  • A minimum of 3 years of relevant experience in a pharmaceutical IT QA role (21 CFR Part 11, GLP OECD 17, GMP Annex 15, GAMP) 
  • A high level of professionalism, demonstrated oral and written communication skills, demonstrated understanding of related fields, and leadership skills (problem solver, ability to deal with multiple priorities, strong interpersonal skills, sound judgement and attentive to details).
  • Must be able to train employees and provide the support needed to meet regulatory timelines and requirements 
  • An understanding/knowledge of the GLPs, GMPs and the  VICH GL9 Good Clinical Practices.

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. 
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to   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

Job: Regulatory Affairs Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck