Axelon
Title : Quality Auditor Associate
Location : Salt Lake City, UT
Shift : 10PM -6:30AM
Description : *Require the physical please, as a lot of their work is in the MFG space*
Responsibility: • Perform sampling and delivery of intermediate and finished products. • Assist with retain sample management. • Conduct monthly GMP and batch-specific room audits. • Perform in process record review of commercial manufacturing batch records. • Review completed swab data and perform subsequent room/equipment release. • Ensures compliance with all Company policies and procedures, including safety rules and regulations. • Performs related duties as assigned.
Education/Certification/Experience: • Requires a minimum of one year experience in a regulated environment such as pharmaceutical, medical device, nutraceutical, or food processing industries. • Requires basic understanding of Good Manufacturing Practice (cGMP) and the application to a production environment. • Associate's degree or higher (or equivalent) achieved or in process preferred.
Skills/Knowledge/Abilities: • Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems. • Self-directed with ability to organize and prioritize work • Ability to communicate effectively with excellent written and oral communication skills • Ability to interact positively and collaborate with co-workers and management
Description : *Require the physical please, as a lot of their work is in the MFG space*
Responsibility: • Perform sampling and delivery of intermediate and finished products. • Assist with retain sample management. • Conduct monthly GMP and batch-specific room audits. • Perform in process record review of commercial manufacturing batch records. • Review completed swab data and perform subsequent room/equipment release. • Ensures compliance with all Company policies and procedures, including safety rules and regulations. • Performs related duties as assigned.
Education/Certification/Experience: • Requires a minimum of one year experience in a regulated environment such as pharmaceutical, medical device, nutraceutical, or food processing industries. • Requires basic understanding of Good Manufacturing Practice (cGMP) and the application to a production environment. • Associate's degree or higher (or equivalent) achieved or in process preferred.
Skills/Knowledge/Abilities: • Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems. • Self-directed with ability to organize and prioritize work • Ability to communicate effectively with excellent written and oral communication skills • Ability to interact positively and collaborate with co-workers and management