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

NIH's Michael Lauer looks at the number of grants, their amount, and funding success rates at the agency for last year.

At Nature, Johns Hopkins' Gundula Bosch describes her graduate program that aims to get doctoral students thinking about the big picture.

Patricia Fara writes about childcare funding, and women in science and science history at NPR.

National Institute of Environmental Health Sciences researchers have visualized the career paths of former postdocs.