QC Analyst II, Analytical - LSA

About the role

The QC Analyst II in Analytical position at Lonza, Portsmouth (NH), USA, operates under general supervision to execute critical cGMP release testing, analytical method transfers, and laboratory investigations across diverse biological and cell-based platforms.

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.
• 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.

Requirements

• 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.

Qualifications

• 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.

Skills

• Superior written and oral communication skills,
• A solutions-focused team attitude,
• The personal initiative required to navigate multiple testing demands without routine reminders.

Benefits

Compensation programs that recognize high performance, medical, dental and vision insurance, as well as PTO and more. For a full list of global benefits, visit: here.