Quality Control Stability Coordinator

Swiss American CDMO, LLC.; Carrollton (TX); On-site; USD 28,000 - 30,000; Full time

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

Pay Range: $20-$22

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 Supervisor
• Learn new processes and procedures
• Maintain annual stability tracking list and request protocols for all studies required products.
• Ensure that all open stability protocols are executed per the protocol requirements
• Provide 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 required
• Coordinate the sampling and submission of stability samples to external laboratories as required by applicable stability protocols, including reviewing production schedule for stability sample requirements
• Coordinate testing of returned samples from external laboratory for testing, as necessary.
• Request quotes from external laboratory for stability studies
• Attending 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.

Qualifications

Required Experience and Skills:

• Experience working in a regulated environment
• Strong problem-solving skills and a hands-on approach to problem solving
• Highly proficient organizational skills which contribute to the ability to efficiently multi-task several objectives at the same time
• Excellent organizational, interpersonal, collaborative, and verbal/written communication skills
• A 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.