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Job Description

Join Us in Shaping the Future of Animal Health

Our company's Animal Health 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.

We are seeking a Quality Assurance (QA) Specialist 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 compnay's Animal Health Quality Manual. The QA Specialist will execute, document, and help optimize quality processes during the build-out and qualification phases and support handover to operations.

As a Specialist in QA, 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 quality system activities tied to the site expansion project, ensuring all tasks meet USDA regulations and company policies.

Support development, review, and controlled release of project-related quality documentation, including but not limited to:

+ Standard Operating Procedures (SOPs)

+ Batch records and supporting documents

+ Validation and qualification protocols and reports (IQ/OQ/PQ as applicable)

+ Risk assessments, and mitigation/corrective action plans

+ Quality forms, logs, and templates needed for operations

Participate in development and execution of validation/verification activities for new/modified processes, equipment, utilities, and facility areas:

+ Assist in developing, reviewing, and approving test protocols and qualification and validation reports

+ Document discrepancies and deviations and support root cause analysis and CAPA implementation

+ Conduct self-inspections, walk-throughs, and pre-operational checks to confirm compliance with USDA, company quality manual, and site requirements

+ Support supplier/vendor quality management activities as they relate to equipment, materials, and service providers for the expansion

+ Assist training new team members and preparing quality training materials and deliver or coordinate quality-related training for operations and project staff

+ Maintain quality records and ensure document control during project activities; ensure traceability and readiness for regulatory review/inspection

+ Monitor and report on quality metrics, project status, and risks; escalate issues to Quality Manager or project leadership as appropriate

+ Facilitate cross-functional coordination (Engineering, Operations, EHS, Regulatory Affairs, Project Management) to ensure quality requirements are incorporated into design, installation, and start-up planning

+ Support pre-commissioning and start-up activities, including initial production runs or trial lots, ensuring sampling, testing, and release procedures are followed

+ Participate in regulatory inspections and assist in responses to findings or observations

+ Contribute to continuous improvement initiatives to strengthen site quality systems post-expansion

Required Education/Experience:

+ Bachelor’s degree in Biology, Microbiology, Chemistry, Animal Science, Quality Management, or related technical discipline required.

+ 3+ years’ experience in quality 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 GMP complaince, batch release, change management, supplier quality management, qualification, and validation.

+ Experience in document control, SOP creation, audit execution, and deviation management.

+ 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 electronic quality management systems (Reliance, Trackwise) or document management systems preferred.

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

Required Skills:

Accountability, Accountability, Adaptability, Aseptic Manufacturing, Audits Compliance, Corrective and Preventive Action (CAPA), Detail-Oriented, Disease Prevention, Documentation Review, Driving Continuous Improvement, Engineering Procurement Construction and Installation (EPCI), GMP Compliance, Immunochemistry, IS Audit, Microbiological Cultures, Microbiology, Production Management, Project Leadership, Quality Assurance (QA), Quality Assurance Tools, Quality Auditing, Quality Management Systems (QMS), Quality Standards, Root Cause Analysis (RCA), Supplier Quality Management {+ 2 more}

Preferred Skills:

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

EEOC GINA Supplement​

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.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$85,600.00 - $134,800.00

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:

11/3/2025

*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.

**Requisition ID:** R370075