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23 days old

Project Manager Labeling Specialist-Hybrid

Kelly Services
Raynham, MA 02767
Kelly Engineering, Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a **Labeling Project Manager** for a long-term engagement at one of our Global clients in Raynham, MA.


**Hybrid!**


This role is a full-time, fully benefitted position. As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. Youll also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews.


KEY JOB RESPONSIBILITIES:


+ Point person for New Product Development Teams in developing labeling strategies, project plans and executing project plans in support of label development for new product launches. Engaged with teams directly and represents labeling function.

+ Maintain product label design and process knowledge for those platforms responsible.

+ Accountable for executing Design Control documentation and execution for label Development.

+ Responsible for leading collaboration for collecting requirements, alignment on label strategy and label content with Regulatory, Clinical, Quality, R&D and FOD as required.

+ Complete technical writing to translate requirements into IFU and labeling content.

+ Accountable for working with Labeling execution planning to align label development project plans with the NPD team schedules, escalating and resolving capacity constraints through prioritization, augmenting capacity or relieving project timing as aligned with NPD team and business units.

+ Accountable for managing multiple project schedules.

+ Accountable for managing project label development budgets and providing cost assessments as required.

+ Review and approve documents representing Labeling as outlined per local quality system procedures as appropriate.

+ Lead and/or support CAPAs as required.

+ Know & follow local Quality System policies & procedures

+ Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures. Complete required periodic re-training in areas such as safety and environmental.

+ Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter work area

+ Ensure multi-project coordination of changes for assigned business units.

+ Other responsibilities may be assigned & not all responsibilities listed may be assigned


EDUCATION / DEGREE REQUIRED:


+ Bachelors Degree Required

+ Project Management Professional Certification preferred


KEY SKILL / KNOWLEDGE REQUIREMENTS:


+ Demonstrated track record of Project Management

+ Conflict Management

+ Advanced proficiency with written and verbal communications

+ Technical Writing skills and experience preferred.

+ Demonstrated track record of Leadership results

+ Demonstrated Change and Stakeholder Management

+ Demonstrated understanding of compliance requirements for medical devices and labeling preferred

+ Labeling Design and development process preferred

+ Demonstrated ability to manage several projects simultaneously

+ Business and financial acumen

+ Customer focused with a good understanding of our customer, NPD and commercial stakeholder needs

+ Design and Change Control

+ PLM System and ERP System knowledge, Adaptiv or EpiCenter and JDE ERP preferred

+ Experienced with Design systems preferred

+ Understands Manufacturing Packaging and Labeling processes

+ Influence Management in a matrix environment

+ Demonstrated people management skills preferred


COMPUTER SKILLS:


+ Proficiency with MS Office

+ Proficiency with Microsoft Projects

+ Proficient or capable of becoming proficient in local applications


EXPERIENCE:


+ Minimum of five years experience in Operations, NPD, Technical Writing, Quality, Compliance, Regulatory and/or Manufacturing with project accountabilities.

+ Demonstrated successful completion of leading or coordinating several projects and/or business challenges

+ Demonstrated ability to collaborate across cross-functional stakeholders and work within a team environment.

+ Demonstrated understanding of the Medical Device or equivalent regulated industry, Quality Systems, labeling requirements and Change Control procedures would be preferred.

+ Experience in a New Product Development project or Lifecycle Project is preferred.


PHYSICAL DEMANDS:


+ Visual acuity for close inspection

+ Typical office work requirements


WORK ENVIRONMENT:


+ Office, laboratory, and manufacturing facilities


Important information: Applicants must be legally permitted to work in the United States immediately and without employer sponsorship. F1 OPT/H1B cannot be considered for this position..


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2022-07-25 Expires: 2022-08-27

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Project Manager Labeling Specialist-Hybrid

Kelly Services
Raynham, MA 02767

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