Quality Assurance Specialist:

Elkton Virginia
Requisition ID: MAN004810

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 individualcarries out a varietyof activitiesto support operationsbecoming familiar with site processes, procedures, and policies as individual develops aligned with cGMPs and HealthAuthority regulations. The role will support facility and equipment qualificationactivities through review and approval of qualification activities, changecontrol, procedures and other related quality systems changes.  May conduct batch record reviews, audits,investigations and help with external audits. The role may support sampling requirements for several areas. 

  • May performs quarantine functions and accountability reviews. 
  • Supports special projectsasassigned. The role follows cGMP and routinely makes decisions usingcGMP/process knowledge.  
  • May work with customers to resolve problemsandtosatisfy quality and production needs.
  • May perform regulatory document reviews and prepare regulatoryor other required documents per local and divisional guidance
  • Follows site safety requirements. Authors, reviews, and or approves data, and documents such as methods, procedures, and protocols. 
  • The individual completes assigned projects as needed. Performs all work in a timelymanner and is an active member of 1 or more teams. 
  • Theindividual tracks/reports metrics asneeded.  
  • Supports aseptic operationsincluding auditing of classified (Grades A/B/C).  Including getting certified for Grade A/Bgowning.


Minimum Requirement:

 Bachelor's degree in Science or Health Science or Engineering; in the absence of a scientific degree applicable experience in pharmaceutical or regulatory/health authority field will be considered.

- Minimum of 3 years experience in the pharmaceutical industry

- Betalactam Antibiotic (Penicillin) – Must not have allergy 


- Previous experience supporting aseptic operations or sterile product, experience in Quality Assurance role

 A degree in microbiology will be extremely useful in this role.

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 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.


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Job: Manuf./Operations Generic
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Employee Status: Regular
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Company Trade Name: Merck
Basic Qualifications