Quality Control Analyst, Instrumentation Computer Validation

United States, Bend (Oregon)
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza Pharma & Biotech has an opening for a Quality Control Analyst, Instrumentation Comput Validation at their Bend, OR location.

As the Quality Control Analyst, Instrumentation Computer Validation, you will be responsible for maintenance, testing, troubleshooting, calibration and repair on a variety of analytical instruments supporting Quality Control. 

Key responsibilities:

  • Responsible for maintenance, testing, troubleshooting, calibration, validation and repair on a variety of analytical instruments working with vendors and internal clients
  • Develop and maintain analytical instrument validation procedures and templates related to laboratory systems to ensure compliance with regulations and GMP (Good Manufacturing Practices)
  • Assist in the Computer System Validation of laboratory systems
  • Author, maintain, and execute documents such as user requirements, protocols, discrepancy reports, summary reports, change controls, CAPAs (Corrective Action/Preventive Action), usage logs, and maintenance records through site Qualify Systems.
  • Schedules on site repair through approved vendors and hosts vendors on site
  • Request quotes and or purchase of specified components and maintain in inventory
  • Assist Subject Matter Expert and present technical expertise in regulatory audit

Key requirements:

  • Bachelor's degree required
  • Working knowledge of instrumentation, validation, and laboratory experience is required
  • Experience in maintenance/repair on analytical instruments
  • Experience with QC (Quality Control) analytical instrument qualification
  • Working knowledge of GxP (Good Practice), Food and Drug Administration rules on Electronic Record/Signatures & Risk Assessment (21 CFR Part 11 & Annex 11) and USP (United States Pharmacopeial Convention, Incorporated) regulations
  • Experience in pharmaceutical/biotechnology or related industry
  • Must be able to travel between sites within Bend

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R45034
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