QA Engineer I
Core
Ensure consistent execution of quality standards and regulatory compliance in a GMP environment for affinity resins.
Role type
QA Engineer I (Quality Management System)
Builds
Quality Management System, Certificates of Analysis, product releases
Domain
Life Sciences / Biotechnology / GMP Manufacturing
Required skills
Quality Management Systems (ISO9001, GMP), Document Management Systems, TrackWise, Root cause analysis, Batch record review, Product release
Preferred skills
Chemistry/Biology/Biotechnology background, Customer problem solving, Continuous improvement
Technologies
TrackWise, Document Management Systems
Responsibilities
Maintain and continuously improve the Quality Management System; Review batch records, generate Certificates of Analysis and release products to the market; Register and review root cause investigations of deviations or complaints in our TrackWise Quality Management System; Understanding and prioritizing customer needs during problem solving initiatives, improving efficiencies and customer satisfaction; Answering customer questions regarding our products.
Seniority
Junior/Mid-level, limited support required
