Labeling Project Coordinator
Proclinical is currently recruiting for a Labeling Project Coordinator with our client located in West Point, PA. Successful candidate will be responsible to read, comprehend, and translate clinical trial protocols/packaging specifications into clinical label generation software.
- Ensures all clinical supplies and associated documentation are processed according to GMPs/GDP's and appropriate safety requirements to meet exacting standards defined by client, 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 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, or other 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 appropriate Corrective 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.
Skills and Requirements:
- BS/BA or 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).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Samantha Reader at (+1) 267-983-0134 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.