Job Description

Quality Assurance Auditor at public.client.lonza.display.name summary:

The Quality Assurance Auditor at Lonza oversees the Quality Control department, ensuring safe working conditions and high-quality results for drug production. This role involves organizing quality tests, adhering to cGMPs, and leading a team to maintain product quality and patient safety. The supervisor is responsible for training staff, problem-solving issues, and fostering a culture of professionalism and disciplined execution.

Today, Lonza is a global leader in life sciences operating across five 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 you to be part of.

Job Summary

The Quality Control (QC), Supervisor will act as a team member of the QC department to support production of in-process and final product drug lots for customers. Organizes and plans quality testing for ongoing customer stability studies. Provide on-time, high quality results to meet Manufacturing demands. The QC Supervisor is responsible for ensuring and providing a safe work environment to the staff in the execution of their work duties. The incumbent is expected to create a culture of disciplined execution and a high level of professionalism for their team while remaining focused on product quality and patient safety. The Supervisor ensures safety procedures are communicated uniformly to all staff. Works on assignments that non-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of advanced technical scope in which analysis of situation or data requires a review of identifiable factors.

Shift: Night, Monday-Friday: 8:30 pm-5:00 am

Key Responsibilities

• The QC Supervisor is responsible for ensuring and providing a safe work environment to the staff in the execution of their work duties.

• Expected to create a culture of disciplined execution and a high level of professionalism for their team while remaining focused on product quality and patient safety.

• Ensures safety procedures are communicated uniformly to all staff. Works on assignments that non-routine in nature where ability to recognize deviation from accepted practice is required.

• Works on problems of advanced technical scope in which analysis of situation or data requires a review of identifiable factors.

• Scheduling, planning, of routine.

• Ensures equipment and the work area is safe for employees to perform their duties.

• Assay/Documentation/Quality System Review.

• Attending department related meetings.

• Independently drive projects to on-time completion.

• Resolving personnel issues and workplace conflict, troubleshooting, problem solving operations and/or performance issues.

• Leading OE initiatives, Improvements, Helping with Transfers, hiring staff.

• Maintain positive attitude and emotional composure in a team environment.

• Timeliness in completing assigned tasks.

• Works entire assigned shift, including arriving and departure on time.

• Makes quality decisions independently and also with guidance from Manager.

• Maintain control of meetings with direct reports.

• Mentoring and leading direct reports.

• Being able to deliver difficult messages to staff (i.e. disciplinary actions, poor performance plans).

• Perform assigned, complex and/or varied tasks.

• Perform other duties as assigned.

Key Requirements

• Bachelor's degree in a scientific field, with a preference for Microbiology or Biochemistry.

• M.S./Ph.D. degree is preferred with 2-5+ years of experience in Quality Control, strictly adhering to cGMPs.

• Ideally 2+ years direct supervisory experience.

• Outstanding ability to speak publicly and maintain control of meetings.

• Outstanding ability to interpret data and troubleshoot assays in area of expertise.

• Excellent ability to prioritize work load for group and problem solve. Changes work within their group quickly in unexpected situations.

• Clearly outlines and gives instructions to analysts in their team.

• Direct, control and plan tasks/projects and brainstorming.

• Excellent ability to communicate in both written and verbal format.

• Is able to clearly communicate via email or memo as required.

• Positive can do attitude, good listener who follows through on requests from management and or staff.

• Able to effectively influence.

• Flexible and adaptable to meet business needs.

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.

Keywords:

Quality Assurance, Quality Control, Pharmaceuticals, cGMP, Team Leadership, Drug Production, Microbiology, Biochemistry, Safety Procedures, Regulatory Compliance

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