Lonza
QC Analyst II, Analytical - LSA
US - Portsmouth, NH · Mid
Sponsorship not specifiedDetected 27 days ago
Process ImprovementGMPPCRFlow CytometryCell CultureProtein AnalysisCommunicationCollaborationMentoring
About the role
- QC Analyst II, Analytical - Large Scale Allogenic Manufacturing Location: Portsmouth, NH, USA.
- 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.
- About Lonza At Lonza, our people are our greatest strength.
Responsibilities
- 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.
- 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.
- Actively support analytical method transfer, verification, and validation activities to successfully onboard new client processes into the testing facility.
- Author, edit, and coordinate corrective and preventive actions (CAPAs) and detail structured Change Controls to promote compliance and continuous laboratory improvement with proper support.
- Develop, modify, and sustain standard operating procedures (SOPs), master forms, and test records to match evolving industry expectations and site improvements.
Requirements
- Technical Mastery: Proven, hands-on experience performing cell culture maintenance, immunophenotyping panels via flow cytometry, PCR amplification, and standard immunological assay techniques.
- Investigation Savvy: Demonstrated ability to actively participate in laboratory event investigations, formulate root-cause theories, and write clear, logical technical summaries.
- 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.
- 2-4 years of direct Quality Control laboratory experience within a cGMP biomanufacturing or regulated clinical testing setting is required.
- Demonstrated ability to actively participate in laboratory event investigations, formulate root-cause theories, and write clear, logical technical summaries.
Nice to have
- Familiarity with Laboratory Information Management Systems (LIMS), enterprise data management applications, and quality systems software (such as TrackWise) is highly preferred.
- 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.
- Systems & Digital Compliance: Familiarity with Laboratory Information Management Systems (LIMS), enterprise data management applications, and quality systems software (such as TrackWise) is highly preferred.
Skills
- 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.
- Innovation thrives when people from all backgrounds bring their unique perspectives to the table.
- Ready to shape the future of life sciences?
Compensation
- Compensation programs that recognize high performance
Benefits
- https://www.lonza.com/careers/benefits.
- Medical, dental and vision insurance, as well as PTO and more
- Education: Bachelor's Degree in Biochemistry, Biology, or a closely related technical science discipline is required.
Company info
- What we're looking for:
This listing is sourced directly from Lonza's careers page and normalized into a canonical job model.