- 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 client, the FDA and EU or other international regulatory agencies.
- May be responsible for any or all of the following:
- 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 and lead 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. he asked that we wait until an official announcement has been made before speaking freely with the team but wanted to make sure we were aware in case any of us received questions. So far only the print techs have been notified.
- Train Label Project Coordinator Level I team members and remain proficient in appropriate systems and software
- Responsible for the physical facility and good housekeeping practices within their area.
- 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).
- SAP (or equivalent) experience strongly preferred
Label Project Coordinator - Pennsylvania, United States - Kelly Science, Engineering, Technology & Telecom
Description
Label Project Coordinator
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.
Responsibilities:
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
Requirements: