Senior Specialist, External Quality Assurance - Business Operations:

West Point Pennsylvania
Requisition ID: EXT000317

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. 

Ourability to excel depends on the integrity, knowledge, imagination, skill,diversity and teamwork of an individual like you.  To this end, westrive to create an environment of mutual respect, encouragement andteamwork.  As part of our global team, you’ll have the opportunity tocollaborate with talented and dedicated colleagues while developing andexpanding your career.


Thisposition supports External Quality Assurance (EQA) under the direction of theBusiness Operations Lead.  This position will support identified systems(e.g., SAP, Supplier Transparency) and process improvements within EQA.Primary responsibilities may include:

  1. Supportthe development, implementation, and maintenance of critical processesvia systems support such as Deviation Management, Product Release, documentationcollaboration, metrics, Change Control, including managing associatedmaster data
  2. Provideongoing production / master data support ensuring EQA data and processesrun smoothly with no interruption to supply
  3. Functionindependently and exercise leadership to identify and implementimprovements to existing business processes and systems; establish newor improved processes, tools, and systems and drive consistent, standardbusiness processes across EQA
  4. Maintainand provide expertise on EQA systems, tools, data, and processes on anongoing basis, such as COMET SAP / RCT, Supplier Transparency, GCM,Orion, RCAM, Tracelink, etc. Serve as the systems / process SME forassigned processes when IT and Business Systems representation isneeded.
  5. Supportthe implementation of strategic projects (e.g., QSIP)
  6. Responsiblefor developing / maintaining / and delivery of training materials andjob aids
  7. Assistin the preparation and coordination of Senior Management presentations
  8. Assurecompliance with established policies/procedures of the Division andCorporation and complies with all applicable governmental regulations(GMP, etc.), both domestic and foreign.
  9. Operate in a safe and efficient manner and incompliance with the MMD QO Safety and Health Policy.


  • BS/BA degree in Engineering, Computers Science, Science or Business
  • Minimum 5 years relevant experience in pharmaceutical industry (e.g., Supply Chain Management, Operations, Quality, and/or IT)
  • Hands-on experience working in COMET SAP (e.g., creation and maintenance of master data / objects – not expense reporting)
  • Ability to navigate complex supply chains and be comfortable working in ambiguity
  • Proven project management proficiency and driving process improvements; leading cross-functional projects/ teams with strong customer focus, inclusion, and collaboration with the ability to analyze complex business processes, develop and implement solutions, and communicate impact to stakeholders.
  • Proficiency using MS Excel and PowerPoint
  • System admin experience - analytical, computer and data mining skills, including software packages used in the maintenance and analysis of data (COMET, SharePoint, Spotfire,).  Experience developing and delivering systems related training
  • Ability to work independently and collaboratively to solve for complex problems, coach/mentor team members and customers, and ensure compliance to processes
  • Navigate in a complex environment with the ability to make ambiguous situations clear to stakeholders (e.g., process mapping, PowerPoint)
  • Experience with Supplier Transparency
  • Strong communication and escalation skills
  • Six Sigma / MPS
  • Ability to work independently and interact with all levels of the organization
  • Working in a cGMP environment with a focus on Data Integrity
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
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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:
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Job: External Manufacturing
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Basic Qualifications