QC Analyst II Analytical - LSA

Lonza Group Ltd.; Portsmouth (NH); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

Paid time off

Lonza benefits program

Job summary

Lonza in Portsmouth, NH is seeking an experienced QC Analyst III to join our Analytical Quality team. You will perform advanced cGMP release testing using flow cytometry, ELISA, PCR, and cell culture to support in-process and final product release.

This senior bench role requires handling method transfers, validations, data review with GDP practices, and leading investigations into OOS results, CAPA generation, and change controls.

Qualifications

• 3-4+ years of direct Quality Control laboratory experience in a cGMP biomanufacturing or regulated clinical testing setting.
• Hands-on experience with flow cytometry, ELISA, PCR, cell culture and standard immunological assays.
• Familiarity with LIMS and quality systems software such as TrackWise is highly preferred.

Responsibilities

• Advanced cGMP release testing using flow cytometry, ELISA, PCR, cell culture and counting to support release.
• Lead analytical method transfers, qualifications, and validation protocols for new methodologies.
• Review raw data and logs for accuracy, ensure GDP compliance, and support investigations of OOS.
• Own CAPA and Change Control activities and drive continuous laboratory improvement.
• Develop and maintain SOPs, master forms, and test records to meet evolving standards.
• Provide hands-on training for junior QC personnel and escalate issues to management.

Skills

Flow cytometry

Cell culture maintenance

Immunophenotyping

PCR amplification

Immunological assays

GDP knowledge

Education

Bachelor's Degree in Biochemistry or Biology

Master's Degree preferred

Tools

LIMS

TrackWise

Job description

QC Analyst III, Analytical - Large Scale Allogenic Manufacturing
Location: Portsmouth, NH, USA.
Schedule: Monday - Friday, 8:00 AM-5:00 PM

We are seeking an advanced laboratory professional to join our Quality organization in Portsmouth, NH, as an Analyst III, QC Analytical. Operating under general supervision, this senior bench-based role executes critical cGMP release testing, handles method validation protocols, and drives complex laboratory investigations.

What will you get? An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance.

• Medical, dental and vision insurance, as well as PTO and more

Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.

What you’ll do:

• Advanced cGMP Release Testing: Execute complex biological, immunological, and cell-based testing - specifically utilizing flow cytometry, ELISA, PCR assays, cell culture, and cell counting - ensuring total compliance with internal SOPs, USP, and EP guidelines to support on-time in-process control and final product release.
• Assay Transfer & Method Validation: Actively spearhead analytical method transfers, qualifications, and validation protocols, including onboarding new methodologies and configuring advanced laboratory instrumentation.
• Data Review & Verification: Review raw laboratory records, data calculations, and execution logs for absolute accuracy, protocol compliance, and strict adherence to Good Documentation Practices (GDP).
• Investigation & OOS Ownership: Lead comprehensive Out-of-Specification (OOS) and laboratory deviation investigations, leveraging root-cause analysis tools to address complex non-conformances with minimal support.
• CAPA & Change Control Management: Author, edit, and coordinate corrective and preventive actions (CAPAs) and detail structured Change Controls to promote compliance and continuous laboratory improvement with minimal support.
• Document Architecture: Develop, modify, and sustain standard operating procedures (SOPs), master forms, and test records to match evolving industry expectations and site improvements.
• Peer Training & Floor Leadership: Deliver hands-on, on-the-job training for junior QC personnel, reviewing data packets, modeling strong work ethics, and escalating critical laboratory anomalies to management as needed.

What we’re looking for:

Experience

3-4+ years of direct Quality Control laboratory experience within a cGMP biomanufacturing or regulated clinical testing setting is required.

Technical Mastery

Proven, hands‑on experience performing cell culture maintenance, immunophenotyping panels via flow cytometry, PCR amplification, and standard immunological assay techniques.

Systems & Digital Compliance

Familiarity with Laboratory Information Management Systems (LIMS), enterprise data management applications, and quality systems software (such as TrackWise) is highly preferred.

Investigation Savvy

Demonstrated ability to independently lead laboratory event investigations, formulate root‑cause theories, and write clear, logical technical summaries.

Education

Bachelor’s Degree in Biochemistry, Biology, or a closely related technical science discipline is required. A Master’s Degree in a scientific discipline is preferred.

Soft Skills

Superior written and oral communication skills, a solutions‑focused team attitude, and the personal initiative required to navigate multiple testing demands and overcome performance roadblocks without routine reminders.

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.

You will feel at home at Lonza if you: Take ownership, step forward, and enjoy meaningful responsibility Love solving problems and thrive in a complex, fast-moving environment Are curious, always looking to learn and improve Work collaboratively, contributing to something bigger than yourself Are motivated to make a difference through work that impacts customers and their patients. Why Lonza: We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, you will have the freedom to grow, the support to succeed and the chance to contribute to work that matters. We are the makers of the medicines of tomorrow. Join us. Be you.