QC Analyst II, Analytical ? Large Scale Allogenic Manufacturing
Location: Portsmouth, NH, USA.
Schedule: Monday ? Friday, 0800 - 1700
We are seeking a laboratory professional to join our Quality organization in Portsmouth, NH, as a QC Analyst II in Analytical. Operating under general supervision, this bench-based role is responsible for executing critical cGMP release testing, analytical method transfers, and laboratory investigations across diverse biological and cell-based platforms.
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: .
What you?ll do:
cGMP Bio-Testing Execution: Perform complex biological, immunological, and cell-based testing?specifically utilizing flow cytometry, ELISA, PCR assays, cell culture, cell counting, and biological potency testing?ensuring total compliance with internal SOPs, USP, and EP guidelines.
Method Transfer & Validation: Actively support analytical method transfer, verification, and validation activities to successfully onboard new client processes into the testing facility.
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 Ownership: Initiate and author comprehensive Out-of-Specification (OOS) and laboratory deviation investigations, leveraging root-cause analysis tools to address non-conformances with proper 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 proper 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 & Mentorship: Lead by example by delivering hands-on, on-the-job training for junior QC personnel, reviewing data packets, and escalating critical laboratory anomalies to management as needed.
Laboratory Stewardship: Maintain laboratory benches, calibrate specialized analytical instrumentation, and propose workflow efficiency upgrades during process improvement events.
What we?re looking for:
Experience: 2?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 actively participate in 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 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.
Ready to shape the future of life sciences? Apply now.
Never miss an opportunity! Create an alert based on the job you applied for.