Sr. Specialist, Quality Control

Merck • De Soto, KS

2d • $106,200 - $167,200 • Remote

About The Position

Our Animal Health Division is investing $895 million in expanding our manufacturing and research & development facilities in De Soto, Kansas — the state’s largest economic development project to date. As a Sr. Specialist, 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. This role combines project leadership/coordination and quality oversight to ensure successful QC laboratory method transfers. The Quality Control Sr. Specialist will ensure laboratory processes and systems are in place to meet Quality Control testing activities associated with the method transfers. The successful candidate will collaborate with cross‑functional teams (Analytical Tech Support, Manufacturing, Validation, Quality Control) to identify gaps and risks, implement appropriate controls, and drive continuous improvement to support the project.

Requirements

• Bachelor’s degree in Biology, Microbiology, Chemistry, Animal Science, Biotechnology, or equivalent experience;
• 10+ years’ of progressive experience/roles within quality control in USDA-regulated animal product facilities
• Experience with USDA regulations and inspection processes in manufacturing environments
• Relevant practical experience with QC laboratory environments, method transfer, or related quality roles in biologics, vaccines, or similar industries
• Experience with qualification of facilities, equipment, instruments, and/or utilities.
• 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); experience with SAP and electronic quality management systems (Reliance, Veeva) preferred.

Nice To Haves

• Experience leading or supporting method transfers and performing go-sees.
• Strong project coordination skills and ability to work with cross-functional teams.
• Experience with implementation of LIMS
• Excellent written and verbal communication skills.

Responsibilities

• Serve as the Project lead for the QC laboratory transfers.
• Serve as the liaison to the project sponsors, keeping them informed of the status of all project activities and resources
• Represent the team at project/tier meetings
• Evaluate site-to-site process/methods
• Resolve any Project Issues in an effective manner
• Ensure teams are formed to support the project, and monitor timelines to ensure that each phase is completed on schedule, preventing delays.
• Coordinate site level activities related to the method transfers.
• Ensure that deliverables meet quality standards before moving to the next phase
• Review/approve required test method information (spec sheets, tests, biomaterials/reagents, release criteria).
• Review/approve protocols and reports associated with the project
• Support completion of Transfer Complexity assessment.
• Author the Quality Risk Management Plan, and support gap assessments.
• Coordinate Change Control plans and review/approve related Change Records.
• Ensure readiness for sample management (sampling plans - transport and handling)
• Support Regulatory Affairs with Outline of Production/Special Outline updates

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: Senior