We are seeking an experienced Quality professional to join our team as a Senior Quality Assurance Specialist. This role plays a key part in maintaining and enhancing the site's Quality Management System while supporting investigations, audits, and continuous improvement initiatives.
What You'll Be Doing
* Leading and supporting investigations into deviations, nonconformances, and OOS/OOT events
* Owning and driving CAPAs and quality improvements
* Performing trending and reporting on QMS metrics
* Acting as a quality lead on site-wide projects
* Supporting and participating in internal and external audits
* Reviewing and approving GMP documentation, procedures, and reports
* Working cross-functionally with Manufacturing, QC, EHS, Engineering, and Maintenance
What We're Looking For
* 4+ years' experience in a cGMP environment (QA preferred)
* Bachelor's degree in Biology, Chemistry, Engineering, or a related scientific field
* Strong understanding of regulatory requirements and QMS processes
* Experience with RCA, investigation writing, and continuous improvement
* Confident communication and presentation skills
* Proficiency with Microsoft Office and strong technical writing ability
If this sounds interesting, Please Apply