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Quality Assurance Analyst II

2 months ago

Fort Worth, United States Randstad Life Sciences US Full time

A global company, we work in over 70 countries and serve patients in more than 140 countries. We have a long history of industry firsts, and each year we commit a substantial amount in Research and Development to meet customer needs and patient demands. Our leadership is grounded in cutting-edge innovation and breakthrough technology, transforming the way we treat eye diseases and eye conditions.


Summary

  • This position, using in-depth knowledge of relevant guidance/regulatory documents, is responsible for instrument qualifications and applications (LIMS, Chromeleon, etc), participate in product/process investigations as needed, ensuring required quality and safety standards are being met for our products and processes.

Responsibilities

  • Perform instrument preventive maintenance, performance verification per schedule and per standards/SOPs as needed.
  • Perform instrument trouble shooting, support investigation per standards/SOPs as needed.
  • Write or review validation protocols and technical reports.
  • Review internal documents / external documents, make recommendation as needed.
  • Collect, calculate, interpret, document and report test results per ALCOA principles.
  • Write and take ownership for SOPs related to testing programs, laboratory operations and/or equipment operation, for validation projects, activities related to instrument qualification, for instrument lifecycle management include procurement, qualification, in-use, maintenance/calibration, performance review and retirement.
  • Perform investigative testing to support laboratory investigations; participate in root cause analysis; lead and write laboratory investigations. Investigate laboratory quality issues and recommend sound corrective actions and resolution.
  • Perform and review equipment calibration and maintenance; serve as instrument advocate.
  • Identify appropriate lab instrumentation purchases; perform qualification/validation.
  • Conduct peer review and approval of data collected by coworkers.
  • Lead laboratory initiatives or programs.
  • Train analysts on internal procedures and test methods.
  • Perform statistical analysis.
  • Utilize change control systems and Inventory management.
  • Act as an SME for critical processes and testing.
  • Lead day to day activities acting as a backup to the supervisor as needed.

Qualifications

  • Bachelor’s in chemistry preferred – or a Master’s degree. PHD =overqualified. If no degree, candidate would need to have a minimum of 10 years of experience working in a lab.
  • Lab experience a MUST