Stability QA Coordinator — Precision Testing & Reporting

Swiss American CDMO, LLC.

Carrollton (TX)

On-site

USD 28,000 - 30,000

Full time

17 hours ago
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Job summary

Swiss American CDMO, LLC. is seeking a Quality Control Stability Coordinator in Carrollton, TX to manage stability testing and documentation for outsourced labs.

The role supports the Stability Supervisor, coordinates protocols, and ensures timely reporting in a regulated environment. The position emphasizes administrative efficiency, cross-functional communication, and adherence to protocol requirements, with opportunities to contribute to process improvements and training within the QC

Qualifications

  • Experience in QA/QC in a regulated setting.
  • Strong organizational and communication abilities.
  • Willingness to learn and work with external labs.

Responsibilities

  • Manage stability documentation and electronic filing, including protocol numbers.
  • Prepare reports for the QC Stability Supervisor.
  • Coordinate sampling and submission of stability tests to external labs.
  • Review stability results and initiate NCRs for OOS findings.
  • Track protocol status and provide weekly updates on activity.
  • Attend gate meetings to update status and requirements.
  • Provide training on protocol requirements as needed.
  • Support day-to-day administrative tasks in QC Stability.

Skills

Regulated environment experience
Problem-solving
Organizational skills
Communication skills
Team-oriented

Education

High school diploma or GED

Job description

Swiss American CDMO, LLC. is seeking a Quality Control Stability Coordinator in Carrollton, TX to manage stability testing and documentation for outsourced labs.

The role supports the Stability Supervisor, coordinates protocols, and ensures timely reporting in a regulated environment. The position emphasizes administrative efficiency, cross-functional communication, and adherence to protocol requirements, with opportunities to contribute to process improvements and training within the QC

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