Label Coordinator

Kelly Services is seeking a Label Coordinator in West Point, PA, to read, comprehend, and translate clinical trial protocols and packaging specifications into clinical label generation software.

 

This position comes with enhanced benefits including paid vacation, holidays and sick time.

 

Length is open ended

 

JOB SUMMARY

  • Responsible to read, comprehend, and translate clinical trial protocols and packaging specifications into clinical label generation software
  • Design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within label systems
  • Interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMP’s

 

JOB DUTIES

  • Ensures all clinical supplies and associated documentation are processed according to GMP’s/GDP’s and appropriate safety requirements to meet exacting standards defined by the FDA and EU or other international regulatory agencies
  • Coordination of Translation Requests
  • Generation of Clinical Label Proofs with CLPG
  • Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address questions, 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 RCEs
  • 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
  • Represent Clinical Packaging on internal or cross-functional team
  • 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

 

JOB QUALIFICATIONS

  • 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

Why Kelly®?

The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.

Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.

The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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