QC Analyst III-Microbial Control at Lonza Biologics Inc. in Portsmouth, New Hampshire

Job Description:

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.

Overview/Role Purpose:

The Quality Microbial Control Analyst 3 will act as a team member of the Quality Microbial Control department to support production of in-process and final product drug lots for customers. Also participate in quality testing for ongoing customer stability studies. Provide on-time, high quality results to meet Manufacturing demands. Applies job skills and company's policies and procedures to complete a variety of tasks of increased scope. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.

Please note the hours for this position:

*Shift is first shift, four 10 hour shifts, Wed-Sat 7AM-530PM*

Key Accountabilities and Duties:

• Applies job skills and company's policies and procedures to complete a variety of tasks.




• Running test samples for In-Process, Lot Release and Stability studies.




• Support Utility and HVAC monitoring and sampling throughout the facility.




• Reviewing assays.




• Training others.




• Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods.




• Projects – such as method transfers, new instruments, method qualifications.




• Use of Microsoft Suites (Word, Excel, PowerPoint.)




• Use of Laboratory computer systems.




• Potential previous use of GMP Quality Systems such as: TrackWise, LIMS.




• Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.




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




• Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.




• Perform other duties as assigned.

Minimum Required Qualifications/Skills:

• Associate’s Degree, Preferred Bachelor's Degree in Microbiology, Biochemistry or Related Science field.




• 3+ years industry experience, preferably in a cGMP environment.




• Use of Microsoft Suites (Word, Excel, PowerPoint).




• Use of Laboratory computer systems.




• Potential previous use of GMP Quality Systems such as: TrackWise, LIMS.




• Solid ability to speak publicly.




• Solid ability to interpret data.




• Perform assigned, complex and/or varied tasks with guidance from Supervisor.




• Prioritization and problem solving.




• Comprehend and follow instructions.




• Direct, control and plan tasks/projects.




• Brainstorming.




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




• Exercises judgment within defined procedures and practices to determine appropriate action.




• Self-motivated team player.




• Completes assignments on-time and accurately.




• Displays commitment to quality and performs job functions to the best of his/her ability.




• Relate to others in a team setting.




• Maintain positive attitude in a team environment.




• Timeliness in completing assigned tasks.




• Works entire assigned shift, including arriving on time.

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.