Stability QC Coordinator: Precision, Compliance, Scheduling

Formulated Solutions; Largo (FL); On-site; USD 65,000 - 90,000; Full time

Job summary

Formulated Solutions is seeking a Stability Coordinator to author stability protocols, coordinate testing, and maintain rigorous study records. This role collaborates with Quality Operations, Manufacturing, and QA to ensure timely, compliant study execution and data integrity throughout CDMO stability programs.

The position reports to the Stability Supervisor and requires strong attention to detail, familiarity with cGMP practices, and experience with stability chambers, LIMS, and QMS

Qualifications

• Working knowledge of cGMP documentation practices.
• Ability to follow approved protocols, SOPs, test methods, and specifications.
• Ability to author clear stability protocols and maintain study records.

Responsibilities

• Author batch-specific stability protocols and amendments.
• Route protocols for technical review and approval before study initiation.
• Maintain current controlled copies of protocols and amendments.
• Receive stability samples, verify identity, and maintain inventory.
• Generate pull notifications and schedule stability testing.
• Coordinate testing with QC, Microbiology, and labs.
• Track results and escalate potential OOS/OOT findings.
• Prepare study files and closeout packages.

Skills

cGMP knowledge

Data integrity

Stability protocol

Cross-functional

Attention to detail

Education

Associate degree in Chemistry/Pharmaceutical Sciences

Tools

MasterControl QMS

LIMS

Excel

Word

Outlook

Job description

Formulated Solutions is seeking a Stability Coordinator to author stability protocols, coordinate testing, and maintain rigorous study records. This role collaborates with Quality Operations, Manufacturing, and QA to ensure timely, compliant study execution and data integrity throughout CDMO stability programs.

The position reports to the Stability Supervisor and requires strong attention to detail, familiarity with cGMP practices, and experience with stability chambers, LIMS, and QMS