QC Analyst III – Environmental Monitoring (Cell Therapy, 2nd Shift)

QC Analyst III – Environmental Monitoring (Cell Therapy, 2nd Shift)

Location: Portsmouth, NH, USA.

Schedule: 2nd Shift, 1:00 PM – 11:30 PM | Wednesday – Saturday

The QC Analyst III is a senior technical member of the Microbial Control team and a critical guardian of our Cell Therapy manufacturing environment. In this advanced role, you do more than execute testing—you provide the technical oversight, mentorship, and investigative expertise required to maintain a world-class aseptic facility. This position is designed for a Quality professional who is ready to lead complex projects, author quality records, and ensure our site remains at the leading edge of microbial control compliance.

What You’ll Get

• Technical Leadership: Step into a role of increased scope where you mentor junior analysts, lead method transfers, and act as a Subject Matter Expert (SME) on the floor.

• Strategic Schedule: Our 4x10 schedule (Wednesday – Saturday) offers three consistent days off (Sunday, Monday, Tuesday) while providing critical senior coverage during our peak late-week production.

• Complex Problem Solving: Own the "why" behind environmental data by leading investigations into deviations and implementing effective CAPAs.

• Full Lonza Benefits: Medical, dental, vision, 401(k), and performance-based incentives. lonza.com/careers/benefits.

What You’ll Do

• Advanced QC Execution: Run complex microbial test samples for In-Process, Lot Release, and Stability studies while performing technical review of assays to ensure total accuracy.

• Quality Record Authorship: Lead the writing and management of Quality Records, including Deviations, CAPAs, Change Controls, and the development of new Test Methods.

• Project Management: Direct and plan technical projects such as method transfers, new instrument qualifications, and method validations within the Cell Therapy asset.

• Mentorship & Training: Act as an example of professionalism and a hands-on trainer for junior analysts, fostering a culture of "Quality First" behavior and aseptic mastery.

• Technical Troubleshooting: Work on problems of moderate to complex scope where you must analyze identifiable factors and exercise judgment to determine appropriate corrective actions.

• Stakeholder Collaboration: Partner closely with Manufacturing and QA to interpret data, brainstorm process improvements, and ensure on-time results for our customers.

Who We’re Looking For

• Experience: 3–10 years of advanced experience in Quality Control or a regulated Laboratory environment is required. A proven track record of working with GMP Quality Systems (such as TrackWise or LIMS) is highly preferred.

• Education: Associate’s Degree in Microbiology, Biochemistry, or a related Science field is required. (A combination of education and experience will be considered).

• Technical Mastery: * Strong ability to interpret complex data independently and present findings to stakeholders.

  • Experience writing and reviewing technical documents and quality records.

  • Ability to direct, control, and plan tasks/projects with minimal supervision.

• Leadership Attributes: You are a self-motivated team player who treats errors as learning opportunities and proactively supports a culture of process improvement.

• Communication: Exceptional written and verbal communication skills, including the ability to speak publicly or present technical data during team meetings or audits.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to lead the future of Quality Control in Cell Therapy? Apply now.