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Specialist, Quality


West Point, PA
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Job Details

Job Title: Specialist, Quality  - QUA006124


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. 


Responsible for the support of the QMS process at the West Point Site. Will work closely with the site QMS lead to ensure all aspects of the program are tracked and coordinated at the WP site.

Work is primarily achieved by individual or through project teams. Understands and applies regulatory/compliance requirements relative to their role. Has developed conceptual and practical expertise in own discipline. Applies knowledge of internal/external processes to drive improvements. Solves complex problems; takes a new perspective using existing solutions. Works independently, receives minimal guidance.

Interprets customer needs, assesses requirements and identifies solutions to non-standard requests. Explains difficult issues and works to build alignment around a complex situation. Makes decisions within guidelines and policies which impact a range of standard and non-standard customer, operational, project or support activities.

Primary activities include, but are not limited to:

-Tracking and coordination of Divisional Quality Alerts and Quality Bulletins
-Tracking and coordination of Site Gap Assessments and Gap Actions
-Tracking and coordination of Site Quality Alerts and Quality Bulletins
-Interfacing with site and divisional personal related to QMS initiatives
-Provides information for regulatory inspections as requested.
-Ensures adherence to divisional reporting requirements and assessments
-Maintains expert level of knowledge relating to core internal procedures and applicable regulations

Individual may have the opportunity to support other areas within the MMD West Point Quality Assurance organization, including:

*SOP and Batch Record Management
*Change Control
*Audits and Inspections
*Automation Compliance
*Deviation Management
*Annual Product Reviews, Vendor Management
*Inspection Management, QMS / Quality Council Management
*Risk Management
*Market Actions


Education Minimum Requirement:


  • Minimum of a Bachelor's degree in Scientific, Engineering or relevant field

Required Experience and Skills:

  • Minimum 3 years in Pharmaceutical Quality, Regulatory, or related experience with progressive and demonstrated Quality decision making responsibility 
  • Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment. 
  • Demonstrated self starter with capability to develop innovative solutions to challenges. 
  • Deliver results across diverse areas at site 
  • Proven analytical aptitude, critical thinking skills, and ability to apply key concepts. 
  • Speaks with courage and candor. 
  • Strong written and verbal communication skills. 
  • In-depth working knowledge and application of GMPs. 

Preferred Experience and Skills:

  • Minimum of 5 years of experience in a Quality position in a GMP environment. 
  • Experience working with various quality systems including MIDAS and TrackWise.
  • Experience with development of quality metrics. 

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 an accommodation for the application process please email us at


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:




Job Qual Assurance & Ops Generic

Primary Location NA-US-PA-West Point

Other Locations 

Employee Status Regular

Number Of Openings 1

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