Quality Systems Coordinator
USWM, LLC•Philadelphia, PA
•$28 - $31•Hybrid
About The Position
The Quality Systems Coordinator supports the maintenance and execution of the Quality Management System (QMS) to ensure compliance with cGMP and regulatory requirements within a cell and gene therapy environment. This role is responsible for coordinating quality system processes, maintaining documentation, supporting investigations, and facilitating continuous improvement activities.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or related field (or equivalent experience)
- 2–5 years of experience in Quality, preferably in pharmaceutical, biotech, or cell & gene therapy industry
- Familiarity with Quality Systems (CAPA, deviations, change control)
- Knowledge of cGMP and regulatory expectations
- Strong organizational and documentation skills
Nice To Haves
- Experience with electronic Quality Management Systems (eQMS) preferred
Responsibilities
- Maintain controlled documents and training records within eQMS
- Coordinate and maintain Quality Systems including deviations, CAPA, change control, and document control
- Ensure accurate and timely documentation in alignment with cGMP requirements
- Track and report quality system metrics and KPIs
- Support investigations and root cause analysis activities
- Assist with CAPA tracking and effectiveness checks
- Support internal and external audits and regulatory inspections
- Coordinate cross-functional communication related to quality systems
- Identify opportunities for continuous improvement and support implementation
- Ensure compliance with internal procedures and regulatory requirements
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
