Quality - Clinical Labeling Specialist

100% Onsite
Actual Position Title: Specialist, MS&T Manufacturing Labeling Systems
Location: Summit West, NJ

PURPOSE AND SCOPE OF POSITION:
Individual contributor to packaging and labeling materials project management, strategic and tactical change planning and forecasting of new product markets and indications launches to ensure the Cell Therapy Operations organization meets its performance objectives. The position will support local site in-process labeling materials artwork strategy, as well as network shared packaging and labeling materials artwork strategy across the product lifecycle. Responsibility to deliver in cross functional teams and drive alignment for packaging and labeling materials projects including manufacturing, engineering, regulatory and supply chain to achieve internal and regulatory requirements. Ensures assurance of supply and compliance to content for new product markets and indications launches, safety updates and other core packaging and labeling materials programs.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• Proficiency in English (both written and oral)
• Experience working effectively across different cultures, multiple functional areas and in complex matrix environments
• Excellent written and oral communication skills with all levels of management and personnel
• Demonstrated success in problem-solving skills
• Strong interpersonal and organizational skills
• Understands Regulatory, Quality and Supply Chain aspects of labeling and impact of non-compliance
• Knowledge of applicable regulations and standards affecting Cell Therapy products, specifically regulations and standards affecting Packaging and Labeling Control.

Education and Experience: Bachelor's Degree in Science, Engineering, Business or Supply Chain with around 3 years' experience in Operations, Regulatory or Quality environment

DUTIES AND RESPONSIBILITIES:
• Individual contributor to strategic and tactical planning for label change projects
• Responsibility for the creation, accuracy, and completeness of label change projects within the Manufacturing Execution System
• Participate in change projects and associated deliverables for launches, site transfers, country/area specific changes, issue resolution and other labeling focused projects
• Ownership role within the packaging and labeling materials artwork strategy
• Support network shared packaging and labeling materials strategy development and maintenance over the product life cycle
• Change Plan contributor for labeling operations
• Act as owner for specific packaging and labeling materials business processes and assume role of documentation subject matter expert

WORKING CONDITIONS (US Only):
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. There are no abnormal conditions caused by noise, dust, etc. Extended hours (>8 hours/day), weekend and/or holidays when required to support the business.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.