Sr. Specialist, Quality Control
Merck · De Soto, KS · Yesterday
Quality Assurance$106k–$167k/yrFull-time
About the role
Join Us in Shaping the Future of Animal Health
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.
Responsibilities
- Serve as the Project lead for the QC laboratory transfers.
- 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.
- Capture and manage all project-related documents.
- 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.
- Support Regulatory Affairs with Outline of Production/Special Outline updates.
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.
- 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.
Preferred Qualifications
- 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.