What are the responsibilities and job description for the Label Project Coordinator III position at Kelly Science, Engineering, Technology & Telecom?
Label Project Coordinator II
Summary:
Team members will be responsible for reading, comprehending, and translating clinical trial protocols/packaging specifications into clinical label generation software. They will design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the label systems.
Individuals will interpret randomization schemes, input them into the label software system, and utilize the system to verify that correct labels are produced according to cGMPs.
Primary Activities:
- Ensure all clinical supplies and associated documentation are processed according to GMPs/GDPs and appropriate safety requirements to meet exacting standards defined by company, the FDA, and EU or other international regulatory agencies.
- Coordinate translation requests, generate clinical label proofs with CLPG, liaise with country-level clinical operations personnel or regulatory affairs, maintain label translations library, interpret clinical study design and clinical supply strategy (CSS), design and verify label models, coordinate MLBL manufacturing with vendors, perform visual inspection and accountability for label proofs and clinical labels.
- Provide detailed analysis of issues, collaborate for creative problem solving, liaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or other stakeholders, represent Clinical Packaging on internal or cross-functional teams, undertake specific projects within the group as needed.
- Participate in complaint and deviation investigations with a focus on true root cause, create appropriate Corrective and Preventative actions (CAPAs), drive CAPAs to closure, train and remain proficient in appropriate systems and software.
Requirements:
- Bachelor's degree (BS/BA) or an 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).
