Stability Coordinator

About the role

The Stability Coordinator is a key member of the Quality Control Team with the primary responsibility of ensuring the stability program is in compliance with current good manufacturing practices (cGMP). This role serves as an essential link between research and development, regulatory affairs, quality systems, and site operations to maintain an inspection-ready stability program for our liquid pharmaceutical and topical antiseptic product lines.

Responsibilities

• Maintain stability standard operating procedures (SOP), protocols, reports, and equipment in a current state.
• Ensure inspection readiness by keeping protocols, samples, equipment, and reports in compliance with SOPs.
• Notify management of investigations, determine root causes, and write investigation reports. Collaborate with Quality Control, Quality Operations, and Quality System for comprehensive report completion.
• Provide routine metric reports and status updates on the stability program to the Quality Council. Deliver stability reports for annual product reviews and metric reports on a routine basis.
• Manage stability chambers, maintain sample inventory, oversee calibration status, and act as the point of contact for out-of-limits notifications. Work with maintenance and engineering to resolve any issues.
• Coordinate annual stability sample management from manufacturing batches, pull samples for Quality Control testing, and manage any outsourced testing.

Qualifications

• Bachelor's degree in science, engineering, or a related pharmaceutical technical discipline.
• 3-5+ years of industry experience in pharmaceutical quality operations, particularly with liquid dosage forms or topical lines.
• Working knowledge of cGMP regulations and stability regulations.

Skills

• Proficiency in quality control, GMP, and laboratory procedures.
• Experience in stability testing, HPLC/GC, wet chemistry, SOP, and data entry.
• Familiarity with LIMS, SLIMS, data integrity, root cause analysis, and investigations.
• Familiarity with stability software programs (SLIMS) and Microsoft Office.
• Ability to organize and coordinate using standard processes.

Work environment

This is an office-based role with frequent interaction in a GMP QC laboratory. The position focuses on coordination, tracking, and communication rather than testing. The facility is a fully FDA-approved site with over 106,000 square feet of space, equipped with state-of-the-art technology, including high-performance liquid chromatography and gas chromatography instrumentation. The work environment promotes a unique, all-in-one pharmaceutical manufacturing and operations process under one roof, ensuring unprecedented quality control.

Pay

The pay range for this position is $32.00 - $36.00/hr.

Schedule

This is a Contract to Hire position based out of Mount Prospect, IL. This is a fully onsite position.