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8 days old

Labeling Project Specialist

Kelly Services
Lansdale, PA 19446
**Label Project Specialist - West Point, PA**


Kelly is currently seeking a Labeling Project Specialist for a long-term engagement at one of our Global clients in West Point PA. This role is a full-time, offering our enhanced benefit package options. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise. All KellyOCG employees receive annual performance reviews.



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



**Responsibilities:**




1. 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.

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




+ Coordination of Translation Requests

+ Generation of 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 RCEs

+ 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.



**Requirements:**




+ BS/BA or appropriate combination of education and relevant practical experience

+ Working knowledge of Packaging Operations and related work centers

+ Previous labeling experience (label proofing or label verification experience)

+ Previous pharma/clinical experience

+ SAP is preferred

+ 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).






**Why Kelly** **** **?**



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2021-01-11 Expires: 2021-02-11

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Labeling Project Specialist

Kelly Services
Lansdale, PA 19446

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