Coordinator, Clinical Supply Operations
About The Position
The Clinical Supply Operations Coordinator generates batch records for clinical packaging activities performed in Lake County. The role coordinates with relevant partners to collect and confirm information, prepares accurate records, routes them for review and approval, tracks progress, and maintains version control. It also supports record quality, document control, data integrity, and timely clinical packaging operations. The position works collaboratively with Clinical Supply, packaging operations, Quality, and other relevant partners. Schedule: Monday–Friday, 6:00 a.m.–2:30 p.m. Central.
Requirements
- Associate degree, or high school diploma with equivalent experience.
- Two years of closely related cGMP manufacturing and supervision experience.
- Demonstrated knowledge of cGMP requirements.
- Extensive experience generating and/or completing cGMP documentation.
- Strong organizational skills and ability to make quick decisions based on shifting priorities.
- Excellent oral, written, and electronic communication skills.
- Excellent attention to detail.
- Goal-oriented, able to lead within a team environment, self-motivated, and able to work with a sense of urgency to meet business needs.
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 applicable 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 authorized records.
- Resolve record questions and discrepancies with 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.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Eligible to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
