Quality Control Stability Coordinator

Swiss American CDMO; 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

Position Summary: Under supervision of the Stability Supervisor, the Quality Control Stability Coordinator is responsible for the maintenance and reporting of stability testing performed by Swiss American through external laboratories, as well as day to day administrative duties assigned by the QC Stability Supervisor.Essential Duties and Responsibilities:Use electronic document systems to search, scan, name and file documents, including the assignment of protocol numbers for stability.Prepare documents and/or reports on behalf of the QC Stability SupervisorLearn new processes and proceduresMaintain annual stability tracking list and request protocols for all studies required products.Ensure that all open stability protocols are executed per the protocol requirementsProvide necessary training to employees on protocol requirements to ensure accurate execution of protocol requirements.Review stability reports and initiate origination of all Non-Conformances (NCRs) for stability Out of Specification (OOS) results.Organize all in-process stability protocols and provide a weekly update on status and/or upcoming protocol activity as requiredCoordinate the sampling and submission of stability samples to external laboratories as required by applicable stability protocols, including reviewing production schedule for stability sample requirementsCoordinate testing of returned samples from external laboratory for testing, as necessary.Request quotes from external laboratory for stability studiesAttending gate meetings, as necessary, to update internal stability testing status and requirements.Other duties may be assigned.Limits of Authority: Interprets work situations and expectations, handles issues which conform to Company policy and past practice, and refers extraordinary situations to the Stability Supervisor or Manager of Validation & Quality Continuous Improvement for guidance when necessary.Required Experience and Skills:Experience working in a regulated environmentStrong problem-solving skills and a hands-on approach to problem solvingHighly proficient organizational skills which contribute to the ability to efficiently multi-task several objectives at the same timeExcellent organizational, interpersonal, collaborative, and verbal/written communication skillsA willingness to work as a contributing member of a dynamic team of individuals.Education/Experience:High school diploma or general education degree (GED); or two years related experience and/or training in a QA/QC position; or equivalent combination of education and experience.