Quality Assurance Inspector II

Quality Assurance Inspector II Responsibilities

• Sample and conduct physical analysis on incoming chemicals and raw materials (classified/ISO environments).
• Perform routine cleaning of classified rooms; conduct room cleaning and environmental monitoring.
• Quarantine, tag/untag, inventory, and coordinate return/destruction of nonconforming materials.
• Inspect and release production materials/components/chemicals to the manufacturing facility; verify intermediate paste shipments.
• Prepare and ship samples to required laboratories; store/dispose retention and reference samples.
• Maintain laboratory/warehouse equipment (routine maintenance/calibrations) and document maintenance.
• Maintain data integrity and comply with SOPs, Material Specifications, FDA, and cGMP.
• Operate powered industrial equipment; assist with internal self-inspections/external audits.
• Initiate deviations and lab investigations; support validations of lab/inspection equipment and methods.
• May provide training and perform other assigned duties.

• High school diploma or GED; 2+ years related experience, or AA/equivalent.
• Familiar with cGMP and FDA.
• Strong attention to detail, organization, follow-up, and verbal/written communication.
• Ability to handle multiple tasks in a fast-paced cross-functional environment; ability to elevate quality issues.
• General computer knowledge; intermediate knowledge of lab/inspection tools, warehouse equipment, and chemical handling.
• Preferred: GDDP, cGMP, and EHS requirements.

• Controlled environment PPE/gowning; cold/wet; may require respiratory protection around chemicals.
• Lift/carry up to 50 lbs; operate warehouse machinery; work multiple shifts/weekends.
• Travel ~5% for business (training/meetings).