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

Lonza•Portsmouth, NH

1d•Onsite

About The Position

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.

Requirements

Experience: 3–10 years of advanced experience in Quality Control or a regulated Laboratory environment is required.
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.

Nice To Haves

A proven track record of working with GMP Quality Systems (such as TrackWise or LIMS) is highly preferred.

Responsibilities

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.