Specialist, Quality Control

Merck • De Soto, KS

3d • Hybrid

About The Position

Our Animal Health Division is investing $895 million in expanding our manufacturing and research & development facilities in De Soto, Kansas. We are seeking a Quality Control Specialist to support the transfer, implementation, and ongoing management of QC methods and processes across sites. This role combines hands-on laboratory activities, project coordination, and quality oversight to ensure successful method and process transfers and maintain QC readiness. The successful candidate will collaborate with cross‑functional teams (R&D, Manufacturing, Validation, Supply Chain, Quality Assurance) to identify gaps and risks, implement appropriate controls, and drive continuous improvement to support the site expansion project and ensure quality systems and day-to-day quality activities are executed to meet USDA regulatory requirements and the Animal Health Quality Manual. For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way. Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do. As a Specialist in Quality Control, you will be part of a world-class team at our Center of Excellence in the Animal Health Corridor, contributing directly to the production of veterinary products that improve animal health and welfare globally.

Requirements

• Bachelor’s degree in Biology, Microbiology, Chemistry, Animal Science, Biotechnology, or equivalent experience;
• 3+ years’ experience in Quality Control / Assurance in USDA-regulated animal product facilities and USDA regulations and inspection processes in manufacturing environments, or equivalent regulated industry (experience during capital/expansion projects is a strong plus)
• Relevant practical experience with QC laboratory environments, method transfer, or related quality roles in biologics, vaccines, or similar industries
• Hands-on experience with laboratory test methods, stability studies, and documentation of test results.
• Knowledge of Good Manufacturing Practices (GMP), quality systems, and regulatory expectations (experience with USDA or other regulatory responses is a plus).
• Strong attention to detail, excellent documentation practices, and ability to maintain audit-ready records
• Effective communication and interpersonal skills; ability to collaborate with cross-functional teams and external vendors
• Proficient with MS Office (Word, Excel, PowerPoint); experience with SAP and electronic quality management systems (Reliance, Trackwise) preferred.

Nice To Haves

• Experience drafting SOPs, Work Instructions, and Master Data Inspection Plans.
• Experience leading or supporting method transfers and performing go-sees.
• Familiarity with root cause analysis, CAPA processes, and risk assessments.
• Strong project coordination skills and ability to work with cross-functional teams.
• Excellent written and verbal communication skills.

Responsibilities

• Execute laboratory process and method transfers between sites, ensuring adherence to technical specifications, according to transfer protocols and acceptance criteria.
• Provide input to Transfer Complexity assessments and support completion of transfer documentation.
• Draft and implement transfer-related SOPs, Work Instructions, and other controlled documents as needed.
• Perform go-sees at sending/receiving sites to observe processes, assess capabilities, and validate readiness.
• Collect, review, and verify required Test Method information and release criteria from specification sheets, Outline of Production documents, validation reports, and biomaterials/reagents lists.
• Verify all relevant specifications (e.g., antigen, FPU, FPP, biomaterials, raw materials).
• Review Master Data Inspection Plans, release times (Goods Received / GR times), and associated data.
• Support gap assessments and risk assessments related to QC capability, method transfers, and site readiness.
• Support Quality Control building activities and contribute to optimization of QC operations.
• Provide quality control oversight on processes and methods to ensure compliance and robustness.
• Participate in post-execution evaluation plans and support corrective actions where needed.
• Support USDA responses and other regulatory actions as required.
• Identify required raw materials and biomaterials; manage and support replenishment activities.
• Perform and monitor QC testing activities, support readiness for QC testing at the site.
• Execute stability studies and monitor stability results over time.
• Support test issue investigations and follow-up activities.
• Identify training needs and requirements for test methods and QC processes.
• Perform and coordinate training; verify training status across site personnel.
• Support development and execution of knowledge transfer plans and continuous improvement initiatives.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level