Quality Engineer I
Description
Verify company’s adherence to the established Quality System and GMP/ISO standards.
• Assist in completion of risk management and risk analysis including FMEA.
• Supports technical and statistical investigations concerning optimization and compliance to specification.
• Assist in measuring process capability, process controls, and process validation / efforts.
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Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements
are considered in product and process development activities
• Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process
• Completing and Documenting Monthly Quality Data Review
• Leading Build At Risk (BAR) Authorizations & Closures
• Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements
• Creation and maintenance of Quality Plans and Reports, typically with mentorship from higher level engineering.
• Executing IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with mentorship from higher level engineering.
• Conducting Advanced Statistical Data Analyses using Minitab typically with mentorship from higher level
engineering.
• Maintenance/update to Master Validation Plans and Reports.
• Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) • Supports activities during preparation and execution of audits (External / Internal)
• Perform other duties and responsibilities as assigned by senior management.