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Quality Specialist


West Point, PA
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Job Details

Job Title: Quality Specialist  - QUA005983


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 Quality Specialist will be responsible for supporting Critical Reagent programs within the Quality Control Laboratories. This is a fast-paced environment within the Vaccine franchises. This position requires experience in either biochemistry or virology assays. Under the guidance of an Associate Director, the Quality Specialist is responsible for managing the complete lifecycle of Critical Reagents (reference materials, positive controls, anti-sera and other critical materials) used in the release and stability testing of vaccine and biological products. Reagent lifecycle includes acquisition, certification and qualification testing, implementation and ongoing monitoring and replacement of the critical reagents as needed. The individual will perform second person document reviews, support activities associated with their position, and ensure work is compliant and conforms to current Good Manufacturing Practices and regulatory expectations. The Quality Specialist will provide bioanalytical support to Global MMD sites, respond to regulatory questions, author analytical license sections and support regulatory inspections. The Quality Specialist must be able to multi-task and work within tight deadlines. This position requires flexibility and the ability to work independently, as well as excellent organizational skills and requires strong professional and interpersonal communication skills.


Education Minimum Requirement:  

  • B.S. in Biochemistry, Biology, Virology or related biological science

Required Experience and Skills:

  • Minimum of 2 years’ experience in biochemistry, virology and/or general cell biology.
  • Laboratory experience, including aseptic techniques.
  • Knowledge of laboratory operations and bioanalytical instrumentation.

Preferred Experience and Skills:

  • Previous technical and/or analytical problem solving experience in vaccine or biologics development, and/or quality site experience. 
  • Proficiency in classical biochemistry assays and molecular biology techniques or cell based assays.
  • Experience in one or more of the following: Cell based assays (TCST & Potency), Molecular Biology, ELISA, HPLC, Rate Nephelometry, Western Blot, Ouchterlony or other Biochemistry based assays.
  • GMP experience.
  • Statistical analysis experience with familiarity with JMP or Minitab.


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 Quality Lab Related

Primary Location NA-US-PA-West Point

Other Locations 

Employee Status Regular

Number Of Openings 1

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