Job Description

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 Responsibilities

* 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 Trace link database for supplier change control notifications and submit site-impacted changes to CRB meeting for PCR development

* Serves as a site contact for multi-site supplier changes initiated in the Trace link database

* Accountable for being a QMS Chapter sub-system owner and presenting associated metrics at Quality Council

* Assumes ownership of PCR 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 Process Change Requests (PCRs) for change prioritization

* Providing business case to VCM Product Lead for the change to evaluate if the change fits within the product strategy

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

* Initiates PCRs, assigns tasks to stakeholders, and tracks PCRs to closure to assure regulatory timelines for implementation are met and that product supply is not interrupted

* Conducts Annual Product Reviews of Product PCRs 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

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

* GCM TrackWise, SAP, Trace link, Supplier Transparency

* 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

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thats devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

No Travel Required

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

None

Number of Openings:

2
Requisition ID:R81948