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Clinical Quality Assurance Specialist

Clinical Quality Assurance Specialist

This position is located in Roseville, MN

 

SUMMARY: The Clinical QA Specialist will be responsible for assessing and maintaining quality systems as they apply to HiberCell’s clinical program.  This individual will work across all HiberCell therapeutic programs and will be expected to adhere to cGMP (good manufacturing practice), GCP (good clinical practice) and Company directives.  Duties will include auditing, writing procedures, reviewing documents, and assessing and developing quality systems for the clinical operations.  From time-to-time GMP-related duties, such as assisting with batch review and release of clinical trial material (CTM), may also be part of the Clinical QA Specialist’s duties.  This position reports directly to the Head of Quality and indirectly to the VP of Program Management.

Position is full-time/exempt.

 

CRITICAL PERFORMANCE AREAS:

 

RESPONSIBILITIES:

 

EDUCATION AND/OR EXPERIENCE:

 

Interested in applying?  Send your resume to HR@hibercell.com