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10 days old

Label Project Coordinator

Kelly Services
Lansdale, PA 19446
Label Project Coordinator Ensures all clinical supplies and associated documentation are processed according to GMPs/GDP s and appropriate Merck safety requirements to meet exacting standards defined by Merck, the FDA and EU or other international regulatory agencies.



May be responsible for any or all of the following:




+ Coordination of Translation Requests - Generation of Clinical Label Proofs with CLPG - Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address question, revise translations, update regulatory requirements, etc. - Maintain Label Translations library - Interpret clinical study design and Clinical Supply Strategy CSS - Design and verify label models - Coordinate MLBL manufacturing at vendors - Perform visual inspection and accountability for label proofs, clinical labels and RCE s

+ Provide detailed analysis of issues and collaborate for creative problem solving

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

+ May represent Clinical Packaging on internal or cross-functional teams. Will undertake specific projects within the group on as needed basis

+ 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.

+ Train and remain proficient in appropriate systems and software

+ 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** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-09-09 Expires: 2019-10-10

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Label Project Coordinator

Kelly Services
Lansdale, PA 19446

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