Quality Auditor Associate

Job Title: Quality Auditor Associate
Location: Salt Lake City, UT 84108 – Onsite
Duration: 5 Months+ (Possible Extension)

Shift: 3rd Shift – 10:00 p.m. – 6:30 a.m., Monday–Friday, Onsite
 
Screenings: Drug – 11-panel w/Fentanyl
 
Basic Medical Tests:

• Vision Screen – Near, Far, Color, Depth, and Peripheral
• Vital Signs
• Audiogram & Noise and Hearing Questionnaire
• Spirometry & OSHA Respirator Questionnaire
• Lifting Assessment (manufacturing, maintenance, warehouse, security, or as indicated) – lifting up to 50 pounds

• 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.
• Ensure compliance with all company policies and procedures, including safety rules and regulations.
• Perform related duties as assigned.

• Handle pharmaceutical drug products, including topical patches, ointments, gels, creams, and oral liquid dosage forms (oral suspension), as well as combination products such as nasal sprays, pump products, and vaginal applicators.
• Drug products include non-controlled substances as well as some DEA controlled substances (Schedule III and IV) and hormones.

• Minimum of 1 year experience in a regulated environment such as pharmaceutical, medical device, nutraceutical, or food processing industries.
• Basic understanding of Good Manufacturing Practice (cGMP) and its application to a production environment.
• Associate’s degree or higher (or equivalent) achieved or in process preferred.

• 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.
• Effective written and oral communication skills.
• Ability to interact positively and collaborate with co-workers and management.