Specialist, Change Control

Job Description

Our Change Control Team supports internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Specialists have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Our company is in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

The Change Control Specialist works closely with Production, Engineering, Technical Services, Quality, Stability, and Planning to align process changes supporting PAI Readiness activities, new product introductions, site optimizations, and marketing-driven initiatives.  Recognized as a subject matter expert in Change Control functions making decisions based on policies, procedures, requirements, and guidelines.

Primary Duties include, but are not limited to:

• Serves as a site-level project manager to implement changes ranging from moderate to complex, high-priority, high-visibility launches with significant above-site/off-site involvement

• Coordinates internal and external resources for the flawless execution of projects delivered on-time by developing a detailed project plan tracking progress to completion

• Monitors supplier notification system database for supplier change control notifications and submits site-impacted changes to CRB meeting for change control development

• Serves as a site contact for multi-site supplier changes initiated in the supplier notification system database

• Responsible for being a QMS Chapter sub-system owner/backup and presenting associated metrics at Quality Council

• Assumes ownership of change control tasks or downstream impact identification for above-site driven changes. 

• Represents PTO on development and commercialization teams as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Global Labeling Operations and other internal or external customers on new and existing products introductions by ensuring products conform to regulatory and compliance obligations (e.g. FDA, EMA, DEA, cGMP, etc.)

• Submits Change Controls for change prioritization

• Provides business case to VCM Product Lead for the change to evaluate if the change fits within the product strategy

• Leads Change Control sub-team meetings to establish requirements across multi-departmental areas in support of new product launches and/or technical transfers

• Initiates Change Controls, assigns tasks to stakeholders, and tracks changes to closure to assure regulatory timelines for implementation are met and that product supply is not interrupted

• Conducts Annual Product Reviews of Product Change Controls ensuring complete and accurate documentation is provided to Quality

• SOP author and/or reviewer for departmental related procedures

Education Minimum Requirements

• Bachelor degree with minimum of two (2) years of pharmaceutical manufacturing experience

• OR

• High School diploma with seven (7) years of applicable pharmaceutical experience in lieu of a degree

Required Experience and Skills

• Extremely detailed in both written and verbal communications/documentation

• Organize and manage multiple projects that span different timelines

• Risk-based decision-making skills without knowledge of all the inputs

• Positive attitude, strong work ethic, ability to work under pressure, and be a fast learner

• Work in a Team-environment and partner cross-functionally

• Strong Microsoft Office Knowledge – especially Outlook, Excel, and Word

Preferred Experience and Skills

• Project Management Professional Certification/Microsoft Project

• MPS fundamentals

• Four (4) years of project management experience with the ability to multi-task

• GCM TrackWise, IPI, SAP, Trace link, Supplier Transparency, RTQ Reliance, Veeva CMS

• Working knowledge of our company's policies & procedures, environmental, safety standards and guidelines, GMP's, governmental regulations (e.g. OSHA), industry and engineering standards

• Understanding of Supply Chain Management, particularly the flow of materials from suppliers and through the Wilson site

#MSJR

Required Skills:

Adaptability, Adaptability, Animal Vaccination, Change Control Management, Computerized Maintenance Management Systems (CMMS), Cross-Functional Communications, Customs Clearing, Data Analysis, Demand Supply Planning, Driving Continuous Improvement, Evaluation Strategy, Immunotherapy, Logistics Management, Manufacturing Compliance, Marketing Initiatives, Marketing Logistics, Oral Communications, Order Management, Pharmaceutical Manufacturing, Pressure Management, Production Planning, Project Management, Project Planning, Project Specifications, Report Writing {+ 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:

EEOC Know Your Rights

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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.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

$79,200.00 - $124,700.00

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:

05/19/2026

*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.