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11 days old

Label Project Coordinator

Kelly Services
Lansdale, PA 19446
**Label Project Coordinator**


**Summary:** 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 clients label systems. Individual will interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.


**Primary activities**


1. Ensures all clinical supplies and associated documentation are processed according to GMPs/GDPs and appropriate safety requirements to meet exacting standards defined by the client, the FDA and EU or other international regulatory agencies.

2. May be responsible for any or all of the following

1. Generation of Clinical Label Proofs with CLP

2. Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address question, revise translations, update regulatory requirements, etc.

3. Maintain Label Translations library

4. Interpret clinical study design and Clinical Supply Strategy (CSS)

5. Design and verify label models

6. Coordinate MLBL manufacturing at vendor

7. Perform visual inspection and accountability for label proofs, clinical labels and RCEs

3. Provide detailed analysis of issues and collaborate for creative problem solving

4. Liaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or other stakeholders.

5. May represent Clinical Packaging on internal or cross-functional teams. Will undertake specific projects within the group on as needed basis

6. 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.

7. Train and remain proficient in appropriate systems and software

8. Responsible for the physical facility and good housekeeping practices within their area.


**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).


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-09-14 Expires: 2022-10-15

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Label Project Coordinator

Kelly Services
Lansdale, PA 19446

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