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Principal Quality Engineer
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$104,000 - $143,000 a year
Full-time
- Organize, review, and perform computer system validation or other software validation related evaluations to support the Master Validation Plan. Support the data integrity initiatives to relevant systems, processes, and equipment.
- Document such actions within the quality system as appropriate (NCR/CAPA).
- Lead process improvement projects (scrap reduction, defect reduction, etc.)
- Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation for responsible areas.
- Knowledge of GMP/manufacturing environment and regulatory compliance for the manufacturing of bulk and finished products and current industry standards related to sterilization, cleaning and other validation processes
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