Quality Control Analyst II - Environmental Monitoring

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 to be part of.

This role supports the Quality Control, Environmental Monitoring team in maintaining the cleanrooms for commercial manufacturing and environmental monitoring performance qualifications. This role will also be central in all processes associated with environmental monitoring and integral with environmental investigations, excursion report writing, and general upkeep of the micro department.

Key responsibilities:

• Performs Environmental Monitoring (EM) for both Cell Therapy and Viral Vector applications.

• Provides input to program management regarding quality control capabilities and requirements for method qualification/validation.  Reviews applicable regulatory guidance and internal policy documents to ensure compliance. 

• Responsible for relaying pertinent information such as production schedules and information requests to applicable QC groups. 

• May write and revise Standard Operating Procedures, perform project related tasks as assigned with detailed instruction, train other lab analysts on routine test methods, perform other duties as assigned.

• Writes, reviews, and/or approves test records/forms, sampling plans, and specifications. 

• Supports Aseptic Process Simulations (APS) by performing EM, screening and counting fill-samples, and completing APS related documentation.

• Works in cooperation with Bioanalytical Services to design qualification, and validation protocols.  May participate in the execution of such protocols as needed to support lab(s).   

• Assists with quality control procurement, setup, and validation activities for new equipment and materials required to support new methodology. 

• Assists with responses to audits, deviations, out of specification (OOS) investigations, and corrective/preventative actions (CAPA).

Key requirements:

• Bachelor's of Science in microbiology or related field.

• Experienced in QC Environmental Monitoring function for the biotech/pharmaceutical industry.

• Must be able to comply and adhere to Good Manufacturing Practices (cGMP) principles.  

• Knowledge of/ability to learn microbiological methods, microbial identification systems and use of lab equipment

• Must have strong organizational skills and be able to manage and prioritize multiple projects or assignments at one time, including the ability to follow assignments through to completion and meet deadlines.

• Demonstrate an understanding of regulatory, compliance, and validation issues, as well as experience in writing and reviewing the associated technical documents, Standard Operating Procedures (SOPs), and protocols.

• Computer software skills including Microsoft Office and SAP. 

• Independent work skills, strong work ethic.

• Experience with MODA-EM data management software desired.

• Aseptic gowning experience 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.