Quality Assurance/Quality Control

Job Location
Salt Lake City, UT
Job Description

Complete implementation of FDA compliant Quality Management System (QMS) to support DiscGenics’ 
first-in-human clinical trial, and support future clinical trial and commercial manufacturing. 
• Identify and close gaps in existing QMS to comply with FDA regulations on the manufacture of 
and clinical trials for a combination biologic/medical device 
• Oversee development of manufacturing process instructions and batch records 
• Fill quality role in design control 
• Qualify reagents/device components and their vendors/suppliers 
• Execute external quality audits on CMOs, CROs, etc. 
• Perform internal quality audits 
• Support/author quality related portions of CMC section of IND 
• QA of IND submission (eCTD support) 
• Oversee document control function


• Minimum 2 years experience in Quality Management in life sciences (biologics, pharma, or 
medical devices) 
• Minimum of bachelor’s degree in relevant field 
• Experience with 21 CFR 211 and/or 21 CFR 820 and/or 21 CFR 1271 
• Experience performing internal and/or external audits 
• Able to proactively identify quality gaps, and implement appropriate solutions 
• Strong communication and technical writing skills 
• Very detail oriented 
• Able to work in a team 
• Able to work on multiple projects under constrained deadlines

New study finds bias against female lecturers among student course evaluations, the Economist reports.

A research duo finds that science and technology graduate students who turn away from academic careers do so because of changes in their own interests.

Students whose classmates are interested in science are more likely to think about a career in science, technology, engineering, and mathematics, a new study says.

CNBC reports that the genetic counseling field is expected to grow as personalized medicine becomes more common.