Quality Analyst I

About This Role

This role involves performing sampling and delivery of intermediate and finished products, managing retain samples, and conducting GMP and batch-specific room audits. The Quality Analyst I will review manufacturing batch records and swab data to ensure compliance with company policies and safety regulations in a regulated environment.

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 perform subsequent room/equipment release
• Ensure compliance with all Company policies and procedures, including safety rules and regulations

Requirements

• Minimum of one year experience in a regulated environment (pharmaceutical, medical device, nutraceutical, or food processing)
• Basic understanding of Good Manufacturing Practice (cGMP) and its application to a production environment
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS and ERP systems

Qualifications

• Associate's degree or higher (or equivalent) achieved or in process preferred
• Minimum of one year experience in a regulated environment such as pharmaceutical, medical device, nutraceutical, or food processing industries

Nice to Have

• Associate's degree or higher (or equivalent) achieved or in process

Skills

* Required skills