Specialist, Quality Control

Merck Merck · Pharma · KS

This role supports the transfer, implementation, and ongoing management of Quality Control (QC) methods and processes within Merck's Animal Health Division. It involves hands-on laboratory work, project coordination, and quality oversight to ensure compliance with USDA regulations and internal quality standards, particularly during a site expansion project. The specialist will collaborate with cross-functional teams, manage test methods and specifications, conduct gap and risk assessments, and support investigations and training.

What you'd actually do

  1. Execute laboratory process and method transfers between sites, ensuring adherence to technical specifications, according to transfer protocols and acceptance criteria.
  2. Collect, review, and verify required Test Method information and release criteria from specification sheets, Outline of Production documents, validation reports, and biomaterials/reagents lists.
  3. Support gap assessments and risk assessments related to QC capability, method transfers, and site readiness.
  4. Identify required raw materials and biomaterials; manage and support replenishment activities.
  5. Identify training needs and requirements for test methods and QC processes.

Skills

Required

  • 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
  • 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
  • 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)

Nice to have

  • Experience during capital/expansion projects is a strong plus
  • experience with USDA or other regulatory responses is a plus
  • experience with SAP and electronic quality management systems (Reliance, Trackwise) preferred
  • 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.

What the JD emphasized

  • USDA-regulated animal product facilities
  • USDA regulations and inspection processes