QC Analyst II

Hayward, California

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, 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.

The QC Analyst will conduct 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.
  • Support and potentially lead continuous improvement projects in the QC Laboratories such as 5S, Kaizen, Just-do-it's, and VIP.
  • 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.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
  • Investigate deviations and write non conformance 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 6S throughout daily work activities.
  • Ensure personal training requirements are met and that training records are current.

Key requirements:

  • Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
  • Effective organizational skills and ability to plan and suggest resolutions to technical problems.
  • Demonstrated working knowledge of assays/equipment in functional area.
  • Computer literate and competent with a working knowledge of word processing and spreadsheets (such as Microsoft Office).
  • Must be detail-oriented, conscientious, and responsible.
  • Capable of applying some decisions-making to problem-solve technical, compliance, or operational problems as assigned.
  • Effective interpersonal communication.  Must have effective verbal and written communication skills.
  • Can demonstrate the ability to guide people, encourage teamwork, and teach assays.
  • Working knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs.
  • Some project management skills.  Good leadership, organization, and time management skills.
  • Demonstrated knowledge of Lean and/or Six Sigma.  Lean Instructor training or equivalent is strongly desired.
  • Must be able to learn new computer systems and programs in a timely manner.

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: R19936