Specialist, Quality Control

Job Description

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.

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.

Key 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.

Test Methods, Specifications, and Master Data

• 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.

Quality Oversight, Risk and Gap Assessment

• 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.

Laboratory Execution & Investigations

• 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.

Training and Knowledge Management

• 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.

Job 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.

 

Preferred Qualifications

• 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.

 

Physical and Work Environment

• Primarily laboratory and office-based with occasional travel between sites.

• Must be able to work in a controlled laboratory environment and follow safety protocols.

• Ability to travel for site visits/go-sees as required.

What We’re Looking For

We seek individuals who:

• Demonstrate execution excellence through effective problem-solving and critical thinking.

• Embrace an entrepreneurial mindset, taking initiative and ownership of their work.

• Adapt with agility and resilience in a dynamic, fast-paced environment.

• Uphold a safety-first mindset, ensuring the well-being of themselves and their colleagues.

• Can prioritize tasks and manage time effectively in a dynamic, project-driven environment

• Demonstrate proactivity, adaptability, and be comfortable working in a matrix organization

Why Join Us?

• Be part of a transformative investment that will shape the future of animal health.

• Work in a region renowned for its skilled workforce, strategic location, and robust infrastructure.

• Contribute to cutting-edge research and manufacturing of large-molecule vaccines and biologic products.

• Help us meet growing global demand for our portfolio of animal health solutions 

GAHM-ILC

Required Skills:

Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Animal Biotechnology, Animal Science, Dissolution Testing, Driving Continuous Improvement, GMP Compliance, Good Manufacturing Practices (GMP), Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Laboratory Techniques, Laboratory Testing, Microbiological Analysis, Microbiological Test, Microbiology, Molecular Microbiology, Program Implementation, Project Coordination, Quality Assurance (QA), Risk Assessments, SAP Enterprise Resource Planning (ERP), Teamwork {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

$87,300.00 - $137,400.00

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:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/26/2026

*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.