AbbVie Clinical Supply Operations Coordinator at AbbVie responsible for generating batch records for clinical packaging activities. Coordinate with partners, ensure record accuracy, and support process improvements.
Responsibilities
Generate batch records for clinical packaging activities performed in Lake County.
Coordinate with relevant partners to gather and confirm the information needed to prepare accurate records.
Check records for completeness, consistency, and alignment with approved source information and applicable procedures.
Route records for review and approval, track their status, and follow up on outstanding actions to support packaging timelines.
Incorporate approved changes and maintain clear version control so teams use the current authorized records.
Resolve record questions and discrepancies with the appropriate subject-matter experts; escalate issues that may affect accuracy, readiness, or timing.
Maintain organized, traceable records and follow applicable document-control and data-integrity practices.
Support process improvements that strengthen record quality, consistency, and turnaround time.
Work collaboratively with Clinical Supply, packaging operations, Quality, and other relevant partners.
Associates Degree or High School Diploma with equivalent experience. 2 years of closely related cGMP manufacturing and supervision experience.
Demonstrated knowledge of cGMP requirements.
Must be goal oriented, able to lead within a team environment, self-motivated and work with a sense of urgency to meet business needs.
Qualification
Strong organizational skillsExcellent oralExcellent attention to detail
Required
Associates Degree or High School Diploma with equivalent experience
2 years of closely related cGMP manufacturing and supervision experience
