14 days old

Quality Control Analyst II

US02 Lonza Biologics Inc.
Hayward, CA 94541
  • Job Code


Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, theres 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 thats the kind of work we want to be part of.

The Quality Control AnalystIIis responsible for performing biological, chemical and physical analyses on pharmaceutical products and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs.

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 some supervision.
  • Testing as required supporting microbial identifications, bioburden analysis, biological indicators, growth promotion, water, and endotoxin. Will be required to read microbial plates and interpret test results. Some troubleshooting will be required.
  • Support and potentially lead continuous improvement projects in the QM Laboratories such as 5S and Kaizen.
  • Serve as Mentor to Quality Control Analyst (QCA) I positions. Provide training and work direction for QCA I positions as required.
  • Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data.
  • Perform advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles.
  • Complete all testing, including special project / protocol testing in a timely and appropriate manner.
  • Pickup, receive, aliquot and distribute samples to the appropriate laboratory.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
  • Investigate deviations, write events, and lab investigation reports.
  • Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
  • Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
  • Perform equipment maintenance and calibrations as required.
  • Support execution of validations for lab equipment, lab methods, or facility projects.
  • May be required to generate, execute, and summarize special laboratory studies.
  • Drive Lean principles such as 5S throughout daily work activities.
  • Ensure personal training requirements are met and that training records are current.

Key requirements:

  • Bachelors degree in a scientific discipline (or equivalent experience) preferred
  • Preferred degree(s): Biology, Microbiology, Biochemistry
  • Intermediateyears laboratory experience
  • Knowledge of aseptic technique and general lab equipment such as a biological safety cabinet, microscope, hemacytometer, and centrifuge.
  • Experience with one or more of the following biological, cell based assays including flow cytometry, immunofluorescent staining, cell growth/proliferation, and cell count/viability.
  • Proficient in the use of spreadsheets, databases, and word processing software.
  • Experience with TrackWise and/or SAP a plus

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.

Posted: 2020-01-08 Expires: 2020-02-06
Sponsored by:
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Sponsored by:
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Quality Control Analyst II

US02 Lonza Biologics Inc.
Hayward, CA 94541

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