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Label Project Coordinator III

Summary

+ 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 Merck label systems.

+ Interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.

+ Perform investigations, update SOPs, manage Change Records, and implement new equipment/processes.

Primary Activities:

+ 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.

+ Coordination and completion of translation requests.

+ 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.

+ 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 Label Room Production 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). Drive CAPA to closure.

+ Train Label Project Coordinator Level I or Level II team members and remain proficient in appropriate systems and software.

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

+ Utilize project management skills to lead and implement new process, technology, and equipment implementation.

+ Update Standard Operations Procedures and Change Records.

Requirements:

+ BS/BA with 5+ years of experience or 8+ years of experience without degree.

+ 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 or general computer skills (i.e. MS Word, Excel, PowerPoint).

+ Project Management skills

+ Technical writing skills.

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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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?

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About Kelly

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Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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 participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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.