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.

Qualifications / Required skills:
- 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 escalate quality issues.
- General computer knowledge; intermediate knowledge of lab/inspection tools, warehouse equipment, and chemical handling.
- Preferred: GDDP, cGMP, and EHS requirements.

Important considerations:
- 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).