Lifecycle Labeling Analyst

Kelly Outsourcing & Consulting Group (Kelly OCG) is happy to exclusively present a career opportunity for a Lifecycle Labeling Analyst in Somerville, NJ.  

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

  • APPLY NOW: start is ASAP
  • Pay: $35.00 - $38.00/hr based on experience
  • Hours: 8:00am to 4:00pm

 

RESPONSIBILITIES:                                                                                                                       

  • Leading collaborative team meetings with cross-functional subject matter experts (SME) to arrive at consensus for labeling content changes.
  • Assuring that all required design inputs are captured and properly documented per franchise procedures.
  • Providing required documentation and labeling change deliverables to lifecycle design control teams.
  • Insuring content collection accuracy, completeness and consistency, across product families and franchises.            
  • Loading documents, information, and creating Change Orders in the change control quality system as required.               
  • Managing label change projects as a subset of broader product design change projects. (i.e. Under the circumstance in which a label change is required as a result of another project driver such as, but not limited to a device, or manufacturing location change).
  • Running projects using project management tools and methods to include kick-off meetings, project plan development, timeline management, risks and issue logs, mitigations, status updates and metrics.                                                                                     
  • Representing the Labeling COE to customer groups, and functional business partners, while responding to and/or escalating requests and inquiries, as needed.       
  • Proactively participating within teams to include inputs of labeling project line items to broader project plan, identification of risks, mitigations and solutions to insure success of achieving overall project goals.                                                                                
  • Proactively communicating to insure understanding of label project plan, risks, issues, mitigations, status updates, and metrics.
  • Collaborating with peers across the COE to support continuous improvement in processes and execution.                                                           
  • Partnering across functions in a way that builds relationships, communicates process and demonstrates excellence in label change execution.         
  • Demonstrating value as a member of the team that enables success of others and team goals.
  • Ability to advocate and coach, representing the brand of the labeling COE and business processes.
  • Management of multiple projects with aggressive project deadlines and schedules
  • Contribute to continuous departmental process improvement efforts.
  • Leading and driving project team meetings in order to achieve schedule adherence.         
  • Ensuring high quality product labeling:                                                             
    • Knowledge of worldwide labeling regulations and corporate directives impacting product labeling are of critical importance.                                                  
    • Ability to function in an environment undergoing constant worldwide regulatory change.                                                                
    • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
    • Lead project teams to identify labeling requirements, and drive consensus when conflicts arise.                                          
    • Verify all executed materials as per established company procedures & assure their accuracy against inputs.                              
    • Maintain all documentation according to GDP (Good Documentation Practices)
    • Initiate and contribute to process improvements, as appropriate                                                                                                              

 

REQUIREMENTS:

  • 3-5 years of experience with at least 1-3 years’ experience related directly to the development of package labeling preferred.
  • Bachelor’s Degree in or qualifying combination of education & related work experience.
  • Demonstrated project management with successful results.
  • Demonstrated achievement of metrics, process improvements preferred.
  • Experience working within a Medical Regulatory environment strongly preferred.
  • Experience with change control systems.                      
  • Project Management Certification strongly preferred.
  • Computer proficiency including Adobe Pro and MS Office Suite (Word, Project, Excel, PowerPoint and Outlook).        
  • Experience working within a team environment comprised of diverse cultural backgrounds and across multiple time zones (via face to face, Webex, SKYPE, etc.).
  • Self-starter, works effectively with general direction/minimal supervision.
  • Project management methodology knowledge.
  • Follow standardized practices and controlled procedures; very detailed-oriented.
  • Strong time-management ability.
  • Able and willing to guide others in area of specialty; Influencing and consensus building.
  • Strong communication skills— written, verbal and across digital mediums necessary for communicating with required stakeholders.  
  • Knowledge and experience of a Product Lifecycle Management (PLM) system.
  • Communicate and interact with all levels of Management as well as cross-functional teams.        
  • Proven experience managing multiple projects simultaneously, must be well organized and flexible to handle multiple tasks.                                                                                                                                                                                                            

ADDITIONAL DETAILS:

**this client requires you to bring your own laptop to work onsite/remote **

  • We appreciate all our applicants, but we are not able to sponsor now; no C2C or H-1B. No third-party suppliers.
  • There is no ‘per diem’ with this position and must be able to work on W-2 hourly basis.
  • There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.
  • As your local offices do not support this position, for immediate consideration, please apply online to this posting directly.
  • Resumes in MS Word are preferred.
  • If you have questions about the position, you may contact the recruiter at Kelly.rush@kellyservices.com; however, your resume must be received via the official posting.

Why Kelly®?

As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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. 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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