Packaging And Labeling Specialist In Clinical

West Point, PA

Posted: 08/03/2022 Job Number: 21349103

Job Description

PACKAGING AND LABELING SPECIALIST IN CLINICAL
WEST POINT, PA
Onsite.

Project Description:
  • 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 company label systems.
  • Individual will interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.
  • Ensures all clinical supplies and associated documentation are processed according to GMPs/GDP's and appropriate company safety requirements to meet exacting standards defined by company, the FDA and EU or other international regulatory agencies.
  • May be responsible for any or all 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.

Required Skills:
  • 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).

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com

ALPHA'S REQUIREMENT #22-02323
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Bridget Burns

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