Job Description
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.
Key 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
Job 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.
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.
Physical and Work Environment
- Primarily office-based with occasional travel between sites.
- Ability to travel for site visits/go-sees as required.
Required Skills:
Adaptability, Good Manufacturing Practices (GMP), Laboratory Information Management System (LIMS), Laboratory Operations, Manufacturing, Manufacturing Environments, Project Coordination, Quality Control (QC), Quality Control Management, Quality Standards, Technical Transfer, Testing, USDA Regulations
Preferred Skills:
Laboratory Quality Control, Quality Management, Quality Management Systems (QMS)
Current Employees apply HERE
Current Contingent Workers apply HERE
The salary range for this role is
$106,200.00 - $167,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
1st - Day
Valid Driving License:
Yes
Hazardous Material(s):
N/A
Job Posting End Date:
07/31/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
