QC Analyst II Analytical - LSA

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Agile career culture

Inclusive workplace

Performance-based compensation

Medical, dental and vision insurance

Paid time off

Job summary

Lonza in Portsmouth, NH seeks an experienced QC Analyst III to join the Analytical group. This senior bench role performs advanced cGMP release testing, method transfers, and complex investigations to ensure timely final product release.

You will review data, maintain GDP standards, and train junior staff while driving CAPA and change-control activities within a robust quality framework.

Qualifications

• 3–4+ years of direct Quality Control laboratory experience in a cGMP biomanufacturing or regulated clinical testing setting.
• Experience performing cell culture maintenance, immunophenotyping via flow cytometry, PCR, and standard immunological assays.

Responsibilities

• Execute complex cGMP release testing (flow cytometry, ELISA, PCR, cell culture).
• Lead analytical method transfers, qualifications, and validation protocols.
• Review raw data, calculations, and logs for GDP compliance and accuracy.
• Lead OOS investigations and non-conformance root-cause analyses.
• Coordinate CAPAs and Change Controls to improve lab processes.
• Develop and update SOPs, master forms, and test records.
• Provide hands-on training for junior QC personnel and escalate anomalies.

Skills

cGMP testing

Data review

Laboratory investigations

GDP documentation

Education

Bachelor in Biochemistry/Biology

Master’s degree preferred

Tools

LIMS

TrackWise

Lab instrumentation

Job description

United States, Portsmouth (New Hampshire)

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.

Reference: R78050