Coordinator, Clinical Supply Operations

AbbVie Inc.; Chicago (IL); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

cGMP knowledge

Leadership

Organization

Decision making

Communication skills

Attention to detail

Formation

Associates Degree or High School Diploma with equivalent experience

Description du poste

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,XandYouTube.

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; escalation 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 orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Company’s sole and absolute discretion, consistent withapplicable 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