Labeling Project Specialist at LanceSoft Inc
West Point, PA 19486
About the Job
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 client 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:
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EEO Employer
Minorities/ Females/ Disabled/ Veterans/ Gender Identity/ Sexual Orient
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Responsibilities:
- Ensures all clinical supplies and associated documentation are processed according to GMPs/GDP's and appropriate Client safety requirements to meet exacting standards defined by Client, 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 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, orother 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 appropriateCorrective 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.
- BS/BA or appropriate combination of education and relevant practical experience
- Working knowledge of Packaging Operations and related work centers
- Previous labeling experience (label proofing or label verification experience)
- Previous pharma/clinical experience
- SAP is preferred
- 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).
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EEO Employer
Minorities/ Females/ Disabled/ Veterans/ Gender Identity/ Sexual Orient
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