Quality Assurance Analyst

USANA is seeking a Quality Assurance Analyst with working knowledge of Quality Engineering to be responsible for all activities involving quality assurance and compliance with applicable GMP and corporate quality requirements.

Responsibilities include writing, reviewing, and revising SOPs as well as writing and executing validation protocols (Equipment and Process Validation, IQ/OQ/PQ, Cleaning Validation, Test Method Validation). The QA Analyst will track, trend, and report QA related information (Deviations, CAPA, OOS, Complaints), track and trend environmental Monitoring programs (temperature/humidity, water, air monitoring),and maintain the Internal Audit program (track, conduct, and report audits). In addition the QA Analyst will administer, review, follow-up, and approve CAPA’s (Corrective and Preventive Action), maintain the product Stability Program (collect/track samples, review data, final reports), maintain the Approved Suppliers List and prepare vendor/supplier GMP Agreements. The QA Analyst will also lead or assist in Investigations related to complaints and manufactured products, prepare routine status reports of Quality Assurance activities, and assist with preparation for regulatory inspections.

Candidates must have a bachelor's degree in a scientific field of study, five or more years of experience in a quality assurance role in a pharmaceutical, medical device, or dietary supplement environment. Candidates must have a working knowledge of cGMP or other quality programs related to pharmaceutical, medical device, or dietary supplement environment and one or more years of experience as a quality auditor, investigator, or quality engineer. Proficiency in MS Suite and excellent communication skills is required. A background in statistical analysis is preferred and vendor audits are strong plus.