An industry pioneer with a core competency in manufacturing for gene and cell therapy is looking for a Quality Engineer. This company supplies high-quality plasmid DNA, mRNA and proteins to our clients, who are breaking new ground on the world's most important and challenging solutions to benefit us all. We're looking for innovative, forward-thinking individuals who share our goals of advancing science and making an impact on the world.
The Quality Engineer interfaces with members of Quality Assurance (QA), Quality Control (QC), Operations, and Facilities teams to review manufacturing and Quality Control documentation, disposition materials, and provide real-time operational oversight. This role performs timely reviews of all batch documentation; assure that batch records are complete, correct, accurate, and satisfy all current Good Manufacturing Practices (cGMP) and all current Good Documentation Practices (cGDP) expectations.
Cross functional support including gap analysis, FMEA, risk assessments, root cause analysis, tracking and trending, statistical modelling (linear regression, T-test, control charts, etc.), and develop/maintain client specific process datasets.
Perform GMP oversight, and "real time" review of manufacturing documentation including batch records and protocols during execution.
Release manufacturing rooms following required reviews and after confirming acceptance criteria have been met.
Assist in developing process capability metrics and other statistical tools to evaluate ongoing process performance.
Able to assess and review SOPs and forms to determine compliance to a standard.
Responsible for timely completion of review and/or investigation into Corrective Action Preventive Actions and other Quality Investigations.
Perform timely and thorough review of all batch documentation to assure that all documentation is complete, accurate, and that it conforms to all regulatory and statutory requirements for release.
Bachelor of Science, life science related, preferred. Equivalent experience may be considered
A minimum of three (3) to five (5) years of experience in a Quality or auditing role. If experience is in an equivalent GMP facility, such as biotech, pharma, medical device manufacturing, etc., 2 years may be considered
Experience working in a regulated or GMP compliant environment