Sr. Quality Engineer, Risk Management @ Piper Companies - Santa Monica, CA

Job Overview

a month ago

Sr. Quality Engineer, Risk Management

Piper Companies - Santa Monica, CA

Piper Companies is actively hiring a Sr. Quality Engineer, Risk Management for a state-of-the-art biotechnology company in Santa Monica, CA. The Sr. Quality Engineer will be responsible for supporting global quality systems guidance, overseeing implementation, and ensuring all Quality processes are risk-based in compliance with applicable procedures and ICH Q9.


Responsibilities of the Sr. Quality Engineer:

  • Assess regulatory and quality risks, propose changes, introduce risk assessment tools and methods
  • Lead Q9 implementation, documentation, and process definitions
  • Train facilitators support regulatory inspections and audits
  • Support quality engineering with system management, computer system validation, and change control expertise

Requirements of the Sr. Quality Engineer:

  • Bachelors or Master's Degree with 5+ years of experience in Quality Risk Management within GMP
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10)
  • Must be eligible to work in the US

Benefits for the Sr. Quality Engineer:

  • Full Medical, Dental, Vision 401k, and PTO
  • Salary up to $115,000 + annual bonus, commensurate with experience

Keywords

GMP, SOP, biotechnology, cell therapy, cancer research, quality risk management, validation, risk assessment, validation life cycles, CSV, R&D, manufacturing, engineering, quality engineer, QRM, system management, change control ICH Q9, regulatory, good manufacturing practices, biotech, computer systems validation, Q9

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