Coordinator, Clinical Supply Operations

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

About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Schedule:

Monday-Friday, 6am - 2:30pm Central

Purpose:

Clinical Supply Operations Coordinator is responsible for generating batch records for clinical packaging activities in Lake County.

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; elevate 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.

Qualifications

• 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.
• Possess extensive experience with generating and/or completing cGMP documentation. Must possess strong organizational skills and the ability to make quick decisions based on shifting priorities.
• Excellent oral, written and electronic communication skills.
• Excellent attention to detail.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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