Labeling Change Control Analyst Job at Stefanini North America and APAC, Round Lake, IL

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  • Stefanini North America and APAC
  • Round Lake, IL

Job Description

Looking for Labeling Project Leader (Medical Device/Pharmaceutical)

Job Description:

  • Provide analytical support to the Product Authentication and Labeling organization under minimal supervision.
  • Responsible for gathering and managing label change control data within the program.
  • Track labeling change deliverables across multiple plants, product codes, create dashboards for management and escalate issues as needed.
  • Create process flows diagrams using MS Visio or similar tools to map current and to-be process, dashboarding skills.
  • Create process to manage and track labeling changes to ensure label changes are issued in time to meet compliance deadlines.
  • Monitor the progress of the label changes and act as a liaison between the project manager and label team.
  • Develops and maintains labeling dashboard & status reports.
  • Assesses project/management issues and develops resolutions in order to meet objectives, which may include quality, customer satisfaction, productivity and costs.
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

QUALIFICATION :

  • Strong interpersonal skills and great attention to detail are necessary.
  • Strong analytical skills, process improvement, problem solving & critical thinking.
  • Ability to respond to customers in a timely manner and communicate effectively.
  • Must be able to handle multiple projects concurrently.
  • Must be a strong team player with good verbal and written communication skills.
  • Proficient in Microsoft Word, Excel, PowerPoint, Visio etc.
  • Experience with labeling in Serialization/UDI preferred, familiarity with electronic change control systems, labeling management systems, PLM etc a plus.
  • Knowledge of FDA Regulations, Application of Good Manufacturing Practices and Good Documentation Practices preferred.
  • Bachelor's degree or equivalent required.
  • Minimum of 3-5 years professional experience required.
  • Labeling and change control experience required.

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