Quality Auditor Associate

Job Responsibilities:

• 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 performed subsequent room/equipment release.
• Ensures compliance with all Company policies and procedures, including safety rules and regulations.
• Performs related duties as assigned.

Skills:

• 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.
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems.

Education/Experience:

• Associate’s degree or higher (or equivalent) achieved or in process preferred.