Label Coordinator-Translation Coordinator

We are currently looking to hire a Label Coordinator-Translation Coordinator for one of our top Pharmaceutical clients in West Point, PA for a long-term contract position with enhanced benefits (medical, dental, paid time off, etc).

Summary: 

  • Read, comprehend, and translate clinical trial protocols /packaging specifications into clinical label generation software.
  • Design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the company label systems.
  • Interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Nichole Kemerer at (nichole.kemerer@kellyservices.com) for immediate consideration.

 

Primary activities: 

Ensures all clinical supplies and associated documentation are processed according to GMPs/GDP s and appropriate safety requirements to meet exacting standards defined by the company, 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

Benefits and Perks: You’ll enjoy competitive pay as well as a comprehensive array of benefits for which you may be eligible, including:

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • 401 (k)
  • Paid Time Off
  • Paid Holidays
  • Online Training via the Kelly Learning Center

Why Kelly®?

Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.

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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