What are the responsibilities and job description for the Stability Coordinator position at Swiss American CDMO?
Job Details
Job Location
Corporate - CARROLLTON, TX
Position Type
Full Time
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
Qualifications
Essential Skills and Qualifications:
Job Location
Corporate - CARROLLTON, TX
Position Type
Full Time
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 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.
Qualifications
Essential Skills and Qualifications:
- High School Diploma or GED.
- 2 years of relevant experience in a Quality Assurance/Quality Control (QA/QC) role within a regulated environment.
- Strong understanding of Swiss protocols and their application to various production processes.
- Ability to accurately interpret and apply analytical test data and technical procedures.
- Excellent problem-solving and analytical skills with a hands-on approach to resolving quality issues.
- Highly organized with the ability to efficiently multi-task and prioritize competing demands.
- Excellent written and verbal communication skills.
- Ability to effectively communicate with supervisors, managers, clients, and customers.
- Strong interpersonal and collaborative skills.
- Proficiency in Microsoft Office Suite (especially Excel), email, and internet software. Experience with SA ERP and QMS systems a plus.
- A willingness to work as a contributing member of a dynamic team.
- Strong attention to detail and accuracy.
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The noise level in the work environment is usually moderate.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to lift up to 50lbs on a regular basis.
