Clinical Supply Ops Coordinator: Batch Records & Compliance

AbbVie; North Chicago (IL); On-site; USD 48,000 - 72,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in Lake County is seeking a Clinical Supply Operations Coordinator who will generate batch records for clinical packaging activities and coordinate with internal partners to ensure accurate, complete documentation.

The role requires a high level of cGMP knowledge, strong organizational skills, and the ability to lead a small team while maintaining rigorous record control and timely packaging timelines.

Qualifications

• Associates Degree or High School Diploma with equivalent experience.
• Demonstrated knowledge of cGMP requirements.
• Must be goal oriented, able to lead within a team environment, self-motivated and work with urgency to meet business needs.
• Extensive experience with generating and/or completing cGMP documentation.
• Excellent oral, written and electronic communication skills.
• Excellent attention to detail.

Responsibilities

• Generate batch records for clinical packaging activities performed in Lake County.
• Coordinate with relevant partners to gather and confirm information needed to prepare accurate records.
• Check records for completeness, consistency, and alignment with approved source information and procedures.
• Route records for review and approval, track status, and follow up on outstanding actions to support packaging timelines.
• Incorporate approved changes and maintain version control so teams use current records.
• Resolve record questions and discrepancies with subject-matter experts; elevate issues affecting accuracy, readiness, or timing.
• Maintain organized, traceable records and follow 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 partners.

Skills

cGMP knowledge

Documentation skills

Communication skills

Organizational skills

Team leadership

Decision making under pressure

Education

Associates degree or high school diploma with 2 years cGMP experience

Job description

AbbVie in Lake County is seeking a Clinical Supply Operations Coordinator who will generate batch records for clinical packaging activities and coordinate with internal partners to ensure accurate, complete documentation.

The role requires a high level of cGMP knowledge, strong organizational skills, and the ability to lead a small team while maintaining rigorous record control and timely packaging timelines.