Quality Control Stability Coordinator

Swiss American CDMO•Carrollton, TX

1d•Onsite

About The Position

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.

Requirements

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.
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.

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.