Specialist, Change Control

Merck•Wilson, NC

5d•Onsite

About The Position

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.

Requirements

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
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

Nice To Haves

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

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 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