Label Project Coordinator
Kelly Outsourcing Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Label Project Coordinator dedicated to work directly with our major Pharma client in West Point PA.
This role is a full-time opportunity with no end date and offers our enhanced benefit package. As a Kelly employee you will be eligible for Medical, Dental options and a variety of other benefits to choose from. You'll also be eligible for paid time off, including holiday, vacation and sick/personal time.
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 label systems. Individual will interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.
- 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
- 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 (Capias'). Drive Capias' to closure
- Train and remain proficient in appropriate systems and software
- Responsible for the physical facility and good housekeeping practices within their area
- May be responsible for any or all the following:
- Coordination of Translation Requests
- Generation of Clinical Label Proofs with LPG
- 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 MLB manufacturing at vendors
- Perform visual inspection and accountability for label proofs, clinical labels and Près'
- 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)
As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work—just ask the nearly 500,000 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, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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. 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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