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Label Project Technician
West Point, PA, US
Engineering
High School or equivalent
Full Time, Direct Hire
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
West Point, PA, US
Experienced (Non-Manager)
Full Time, Direct Hire
Biotechnology/Pharmaceuticals
On-site
Engineering
High School or equivalent
First Shift (Day)
Job details
Label Project Coordinator III
Summary
- 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 Merck label systems.
- Interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.
- Perform investigations, update SOPs, manage Change Records, and implement new equipment/processes.
Primary Activities:
- Ensures all clinical supplies and associated documentation are processed according to GMPs/GDPs and appropriate Merck safety requirements to meet exacting standards defined by Merck, the FDA and EU or other international regulatory agencies.
- Coordination and completion of translation requests.
- 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.
- 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 Label Room Production 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). Drive CAPA to closure.
- Train Label Project Coordinator Level I or Level II team members and remain proficient in appropriate systems and software.
- Responsible for the physical facility and good housekeeping practices within their area.
- Utilize project management skills to lead and implement new process, technology, and equipment implementation.
- Update Standard Operations Procedures and Change Records.
Requirements:
- BS/BA with 5+ years of experience or 8+ years of experience without degree.
- 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 or general computer skills (i.e. MS Word, Excel, PowerPoint).
- Project Management skills
- Technical writing skills.
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