About the role
The 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.
Location: West Point, PA. Monday – Friday. 5 days weekly on-site.
Labeling, bottling and/or Translation of labels experience highly preferred.
Pharma/CRO experience highly preferred but other industry experience will be considered.
What you will be doing:
- 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 team, 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 vendor
- 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 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.
- Assist in training new team members and remain proficient in appropriate systems and software
- Responsible for the physical facility and good housekeeping practices within their area.
- Bachelor’s degree preferred Required Experience/Skills:
- 3+ years (with degree)
- 6+ years (without degree)
- Organization, detail oriented, equipment operation skills, equipment repair, problem solving, troubleshooting, interpersonal skills incl. verbal and written, multitasking, collaboration
- Able to connect the dots with task and identify future tasks to be done or whom to engage on next steps; understands supply chain and impact to success or failure of an action up and down the supply chain
