Label Project Coordinator II

Kelly Science and Clinical FSP is currently seeking a Label Project Coordinator II for a long-term engagement in West Point, PA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.

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 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

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

• 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 MLBL 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 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's). Drive CAPA's to closure.

• Train Label Project Coordinator Level I team members 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

• 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).

• SAP (or equivalent) experience strongly preferred

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (~~~) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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 world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's 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

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

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 Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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 Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.