Quality Assurance/Quality Control

Organization
DiscGenics
Job Location
Salt Lake City, UT
Job Description

Purpose: 
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. 
Responsibilities: 
• 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

Requirements: 

Requirements: 
• 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

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