Quality Control Analyst II
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.
The QC Analyst II supports the Quality Control department by performing chemical, and physical analysis of raw materials, in-process samples, bulk drug substance, final product and special project samples. The QC Analyst II will also support the department by assisting in qualification, validations and review of quality records such as local documents, deviations, CAPAs and change records.
- 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 6S, 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 nonconformance 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.
- 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.
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.