Stability QA Coordinator: Lab Coordination & Compliance

Swiss American CDMO, LLC.; United States; On-site; USD 52,000 - 76,000; Full time

Job summary

Swiss American CDMO, LLC. in the United States is seeking a QC Stability Coordinator to manage stability testing programs with external laboratories, maintain comprehensive documentation, and support the Stability Supervisor.

You will coordinate sampling, monitor protocol status, prepare reports, and drive non-conformance investigations, staff training, and gate meeting updates to ensure compliance and timely execution of stability activities.

Qualifications

• Experience in a regulated environment is required.
• Strong problem-solving and hands-on approach.
• Excellent organizational and communication skills.
• Willing to work as a contributing team member.
• Experience with QA/QC documentation is preferred.

Responsibilities

• Coordinate sampling and submission of stability samples to external laboratories.
• Review stability reports and initiate NCRs for stability OOS results.
• Prepare documents and/or reports on behalf of the QC Stability Supervisor.
• Attend gate meetings as necessary to update stability testing status.
• Maintain annual stability tracking list and request protocols.

Skills

Regulated environment experience

Problem-solving

Organizational skills

Communication skills

Team player

Education

High school diploma or GED

Two years QA/QC experience

Job description

Swiss American CDMO, LLC. in the United States is seeking a QC Stability Coordinator to manage stability testing programs with external laboratories, maintain comprehensive documentation, and support the Stability Supervisor.

You will coordinate sampling, monitor protocol status, prepare reports, and drive non-conformance investigations, staff training, and gate meeting updates to ensure compliance and timely execution of stability activities.