Lonza
QC Analyst III, Analytical - LSA
US - Portsmouth, NH · Mid
Sponsorship not specifiedDetected 28 days ago
GMPPCRFlow CytometryCell CultureProtein AnalysisLeadershipCommunicationCollaboration
About the role
- QC Analyst III, Analytical - Large Scale Allogenic Manufacturing Location: Portsmouth, NH, USA.
- About Lonza At Lonza, our people are our greatest strength.
Responsibilities
- 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.
- 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.
- Investigation Savvy: Demonstrated ability to independently lead laboratory event investigations, formulate root-cause theories, and write clear, logical technical summaries.
- 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.
- Author, edit, and coordinate corrective and preventive actions (CAPAs) and detail structured Change Controls to promote compliance and continuous laboratory improvement with minimal support.
- Develop, modify, and sustain standard operating procedures (SOPs), master forms, and test records to match evolving industry expectations and site improvements.
- 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.
Requirements
- Technical Mastery: Proven, hands-on experience performing cell culture maintenance, immunophenotyping panels via flow cytometry, PCR amplification, and standard immunological assay techniques.
- 3-4+ years of direct Quality Control laboratory experience within a cGMP biomanufacturing or regulated clinical testing setting is required.
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.