Quality Control Analyst III

United States, Hayward (California)

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.

A Quality Control  Analyst III: Applies job skills and company's policies and procedures to complete a variety of tasks. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.

Key Responsibilities:

  • Conduct biological, chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility.
  • Work under minimal supervision and is responsible for overseeing daily work activities.
  • Testing as required supporting microbial identifications, bioburden analysis, biological indicators, growth promotion, water, and environmental monitoring samples.
  • Will be required to read microbial plates and interpret test results. Some troubleshooting will be required.
  • Write and execute validations and qualifications for laboratory assay methods, reference materials, and/ or equipment according to current USP and regulatory requirements.
  • Perform review of test data with application of GDP. Assist Lab Manager in managing the control of lab documentation.
  • Perform laboratory investigations and write nonconformance reports.
  • Assure change requests (e.g. CR, DCR, ECR) are performed when required and are completed in a timely manner.
  • Serve as mentor, provide training and work direction to other Quality Control Analysts.
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data. Perform advanced laboratory assays requiring precise analytical skills and understanding of scientific principles.
  • Use Global LIMS or other computerized systems for entering and approving test results.
  • Assist Lab Manager in ensuring and maintaining computerized system integrity.
  • Participate in team setting within the laboratory and project teams to increase efficiency, generate cost savings, improve quality, and provide new product support.
  • Ensure laboratory area is maintained in a GMP audit ready state and lead continuous improvement projects such as 5S, Kaizen, and VIP.
  • Perform equipment maintenance and calibrations as required. May be the subject matter expert on assigned equipment.

Key Requirements:

  • Bachelor or Associates Degree. Preferred area of study in Microbiology, Biochemistry or Related Science Fields.
  • Intermediate industry experience in a cGMP environment.
  • Use of Microsoft Suites (Word, Excel, Powerpoint)
  • Use Laboratory computer systems
  • Experience with GMP Quality Systems such as: TrackWise, LIMS

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

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: R34251
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