About the role
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; 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.
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.
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