Batch Records Specialist — Clinical Supply Operations

AbbVie Inc.; Chicago (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

AbbVie Inc. is seeking a Clinical Supply Operations Coordinator in Illinois to generate batch records for clinical packaging in Lake County.

You will coordinate with partners to ensure complete, accurate documentation and route records for review and approval, maintaining strict version control and data integrity. The role requires strong organizational skills, attention to detail, and the ability to adapt to shifting priorities while collaborating with Clinical Supply, QA, and packaging teams.

Qualifications

• 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.
• Extensive experience with generating and/or completing cGMP documentation; strong organizational skills and quick decision-making.
• 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 partners to gather and confirm information needed to prepare accurate records.
• Check records for completeness, consistency, and alignment with procedures.
• Route records for review/approval, track status, and follow up on actions.
• Maintain version control and ensure use of current records.
• Resolve record questions and discrepancies with subject-matter experts; escalate as needed.
• Maintain organized, traceable records and follow data-integrity practices.
• Support process improvements to strengthen record quality and turnaround time.
• Work with Clinical Supply, packaging operations, Quality, and other partners.

Skills

cGMP knowledge

Leadership

Organization

Decision making

Communication skills

Attention to detail

Education

Associates Degree or High School Diploma with equivalent experience

Job description

AbbVie Inc. is seeking a Clinical Supply Operations Coordinator in Illinois to generate batch records for clinical packaging in Lake County.

You will coordinate with partners to ensure complete, accurate documentation and route records for review and approval, maintaining strict version control and data integrity. The role requires strong organizational skills, attention to detail, and the ability to adapt to shifting priorities while collaborating with Clinical Supply, QA, and packaging teams.