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19 days old

Supply Chain Label Project Coordinator

Kelly Services
Lansdale, PA 19446
**Medica Supply Chain Label Project Coordinator**





Kelly FSP Scientific group, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Label Project Coordinator dedicated to work directly with our major Pharma client in West Point PA.



This role is a full-time opportunity with no end date and offers our enhanced benefit package. As a Kelly employee you will be eligible for Medical, Dental, 401K option 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.



**Summary:** Team member will be responsible to read, comprehend, and translate clinical trial protocols /packaging specifications into clinical label generation software. Individual will design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the label systems. Individual will interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.



**Primary activities**




1. Ensures all clinical supplies and associated documentation are processed according to GMPs/GDPs and appropriate safety requirements to meet exacting standards defined by client, the FDA and EU or other international regulatory agencies.

2. May be responsible for any or all the following:

3. Coordination of Translation Requests

4. Generation of Clinical Label Proofs with CLPG

5. Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address question, revise translations, update regulatory requirements, etc.

6. Maintain Label Translations library

7. Interpret clinical study design and Clinical Supply Strategy (CSS)

8. Design and verify label models

9. Coordinate MLBL manufacturing at vendors

10. Perform visual inspection and accountability for label proofs, clinical labels and RCEs

11. Provide detailed analysis of issues and collaborate for creative problem solving

12. Liaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or other stakeholders.

13. May represent Clinical Packaging on internal or cross-functional teams.

14. Will undertake specific projects within the group on as needed basis

15. Participate as necessary in complaint and deviation investigations with a focus on true root cause, and creation of appropriate Corrective and Preventative actions (CAPA's). Drive CAPA's to closure.

16. Train and remain proficient in appropriate systems and software

17. Responsible for the physical facility and good housekeeping practices within their area.



**Requirements:**




+ BS/BA or appropriate combination of education and relevant practical experience

+ Working knowledge of Packaging Operations and related work centers

+ Proactive approach to work, identifying potential issues and bringing them to the attention of appropriate personnel for resolution

+ Strong attention to detail

+ Strong verbal and written communication skills

+ Strong organizational skills, ability to prioritize and ability to multi-task

+ Knowledge of general computer skills (i.e. MS Word, Excel, PowerPoint).




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



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 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** , 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. 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.

\#KellyGTS

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Posted: 2020-10-12 Expires: 2020-11-12

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Supply Chain Label Project Coordinator

Kelly Services
Lansdale, PA 19446

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