Label Project Coordinator II

Kelly Science and Clinical FSP is currently seeking a Label Project Coordinator II for a long-term engagement with one of our Global Pharmaceutical clients. This position is hybrid in West Point, PA. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options.

As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

The Label Project Coordinator II is responsible for identifying future tasks and engaging with relevant stakeholders. This role requires a deeper understanding of supply chain impacts. The Label Project Coordinator II will be responsible for reading, comprehending, and translating clinical trial protocols/packaging specifications into clinical label generation software. The Label Project Coordinator II will design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the label systems.

The Label Project Coordinator II will interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.

• Identify future tasks and engage with stakeholders for next steps.
• Collaborate with team members to ensure operational success.
• Maintain accurate documentation related to technical 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 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 content.
• Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address questions, 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 and clinical labels.
• Provide detailed analysis of issues and collaborate for creative problem solving.
• Liaise with Clinical Supply Project Managers, 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.
• 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.

• Bachelor's degree preferred; candidates with relevant experience may be considered.
• 3+ years of experience in a related field; candidates without a degree should have 6+ years of relevant experience.
• Working knowledge of Packaging Operations and related work centers.
• Knowledge of general computer skills (i.e., MS Word, Excel, PowerPoint).

• Strong organizational and detail-oriented skills.
• Problem-solving and troubleshooting abilities.
• Interpersonal skills, including verbal and written communication.

• Understanding supply chain impacts and operational efficiency.

Posted By: Lea Lolley