Specialist, Change Control

Job DescriptionOur 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 involvementCoordinates internal and external resources for the flawless execution of projects delivered on-time by developing a detailed project plan tracking progress to completionMonitors supplier notification system database for supplier change control notifications and submits site-impacted changes to CRB meeting for change control developmentServes as a site contact for multi-site supplier changes initiated in the supplier notification system databaseResponsible for being a QMS Chapter sub-system owner/backup and presenting associated metrics at Quality CouncilAssumes 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 prioritizationProvides business case to VCM Product Lead for the change to evaluate if the change fits within the product strategyLeads Change Control sub-team meetings to establish requirements across multi-departmental areas in support of new product launches and/or technical transfersInitiates 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 interruptedConducts Annual Product Reviews of Product Change Controls ensuring complete and accurate documentation is provided to QualitySOP author and/or reviewer for departmental related proceduresEducation Minimum RequirementsBachelor degree with minimum of two (2) years of pharmaceutical manufacturing experienceORHigh School diploma with seven (7) years of applicable pharmaceutical experience in lieu of a degreeRequired Experience and SkillsExtremely detailed in both written and verbal communications/documentationOrganize and manage multiple projects that span different timelinesRisk-based decision-making skills without knowledge of all the inputsPositive attitude, strong work ethic, ability to work under pressure, and be a fast learnerWork in a Team-environment and partner cross-functionallyStrong Microsoft Office Knowledge – especially Outlook, Excel, and WordPreferred Experience and SkillsProject Management Professional Certification/Microsoft ProjectMPS fundamentalsFour (4) years of project management experience with the ability to multi-taskGCM TrackWise, IPI, SAP, Trace link, Supplier Transparency, RTQ Reliance, Veeva CMSWorking knowledge of our company's policies & procedures, environmental, safety standards and guidelines, GMP's, governmental regulations (e.g. OSHA), industry and engineering standardsUnderstanding of Supply Chain Management, particularly the flow of materials from suppliers and through the Wilson site#MSJRRequired 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 HERECurrent Contingent Workers apply HEREUS 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 perso