Quality Assurance Specialist II

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

**Job Description**

The Quality Assurance team is responsible for reviewing equipment validations, process validations, change control, technical transfers, and new product initiatives for RUO and IVD TDX HLA Typing kits and reagents. Validation work includes the ability to perform risk assessments to identify the extent of validation required. The QA Specialist II position requires the ability to write/review protocols and write/review reports for validation and new design processes. The application of risk assessment methodology is required for this
position in order to support a fast-paced Change Control system while maintaining all IVD Compliance Requirements, where applicable. Technical Transfer activities include reviewing protocols and reports along with cross functional collaboration during...