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QA Specialist I- Quality Engineering

KBI Biopharma

📍 Durham, NC

Posted 4 months ago

Quick Info

Experience Level

Mid Level

Minimum Degree

Bachelor

Department

Quality Assurance Control

Job Type

Full Time

Specialty Skills

GMPQuality AssuranceManufacturing SupportRisk ManagementInspection ReadinessProcess Guidance

About the Role

The Manufacturing Quality Assurance (MQA) Specialist is responsible for supporting the Manufacturing Process and Areas as part of a rapidly expanding GMP Contract Manufacturing Organization. MQA Specialists are expected to provide sound guidance to Manufacturing with respect to process, SISPQ of product, and risk. MQA Specialists share responsibility for the inspection readiness of the site. MQA Specialists routinely work on the cleanroom floor directly with the Manufacturing team to provide real time guidance and support. Specialists routinely collaborate with Manufacturing and work on team initiatives. The MQA Specialist may also be responsible for coaching and mentoring as needed to foster a GMP compliant site.

About KBI Biopharma

Contract Development & Manufacturing

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