Quality Auditor Associate

Description

1st shift early (6 a.m. – 2:30 p.m. M-F)

The job requirements include the following essential areas of 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