Global Labeling Operations Specialist
4 weeks ago
AbbVie is seeking a highly skilled Global Labeling Operations Specialist to join our Collaborative Global Labeling Team based in North Chicago. As a key member of our team, you will be responsible for leading workflow coordination within artwork production and ensuring timely completion of key tasks within artwork projects.
Key Responsibilities:
- Coordinate artwork production in the artwork management system to ensure timely completion.
- Complete redlining, technical documentation, and disposition tasks in the artwork management system.
- Drive exception management for artwork workflow execution and act as primary contact for stakeholders during artwork development, proofreading, and approval.
- Manage the labeling development and implementation schedule to meet established timelines and negotiate exceptions to planned delivery dates.
- Act as owner for specific labeling business processes and assume the role of documentation subject matter expert.
- Key liaison and subject matter expert for packaging and labeling at AbbVie plants and Third-Party Manufacturers.
- Own coordination of regulatory submission required commodity samples.
Qualifications:
- Bachelor's Degree in Business, Engineering, or Sciences preferred. Equivalent successful industry experience (minimum 4 years) can be considered.
- Preferred: Labeling experience in Pharmaceutical or Biotech industry. Minimum of 4-6 years combined experience from the following areas: Quality/Regulatory, Operations, Pharmaceutical/Device Regulations.
- Understands Regulatory, Quality, and Supply Chain aspects of labeling and impact of non-compliance.
- Demonstrate ability to work in a highly cross-functional and global environment.
- Ability to motivate and influence others over whom they have no direct authority.
- Knowledge of applicable regulations and standards affecting Pharmaceutical, Device, Device/Combo Products, specifically regulations and standards affecting the Packaging and Labeling Quality System.
- Self-motivated and strong focus on details and accuracy.
- Strong written and interpersonal communication skills.
- High affinity to IT systems.
About AbbVie:
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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