Quality Assurance Technician; GMP

Overview

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.

Handling of pharmaceutical drug products, including topical patches, ointments, gels, and creams, as well as an oral liquid dosage form (oral suspension) as well as some combination products such nasal sprays, pump products, and vaginal applicators. Our drug products include non-controlled substances as well as some DEA controlled substances (schedule III and IV), as well as hormones.

• 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.