Quality Control Senior Reference Specialist
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 Senior Reference Specialist position is available at the Merck Animal Health facility in Elkhorn, Nebraska, located on the West end of Omaha. The Elkhorn facility is expanding operations to manufacture animal vaccines and biologics. Looking for talented individuals to join our Production teams using key technologies for cell culture, filling and packaging.
The Senior Reference Specialist job responsibilities consist of but not limited to:
- Routine collaboration with Reference Management, Analytical Tech Support, Research & Development, Bioprocess Tech Support, Production, and Quality Control colleagues
- Leads cross-functional reference project teams to qualify current or new licensed product reference standards
- Manages reference standard program for two biologics sites
- Maintains reference standard compliance according to USDA guidelines and requirements
- Provides guidance to Research & Development for new product reference standards, including development of reference standard monitoring programs
- Periodically reviews and prepares in vitro test data for statistical analysis
- Prepares interim reference standard stability reports supporting assigned expiration dating
- Supports stability testing for licensed product reference standards
- Manages reference standard and supporting material inventories
- Supports local, regional, and global program initiatives
- Bachelor’s Degree in a Relevant Biological Area (Bacteriology, Biochemistry, Biology, Genetics, Immunology, Microbiology, Virology)
- At least 7 years Quality Control or Quality Assurance experience in the Animal Health industry
- At least 5 years bench level laboratory experience
- Expanded knowledge in at least one biological area; experience in other biological areas
- Proficient in technical writing and use of Microsoft programs (Excel, PowerPoint, Word)
- Experience managing critical reagent inventories
- Experience preparing and interpreting basic statistical reports
- Experience preparing reports for regulatory authorities
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.
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Job: Regulatory Compliance
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck