QC Analyst III, Analytical - LSA

About the role

Operating under general supervision, this senior bench-based role executes critical cGMP release testing, handles method validation protocols, and drives complex laboratory investigations.

Responsibilities

• 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.
• Actively spearhead analytical method transfers, qualifications, and validation protocols, including onboarding new methodologies and configuring advanced laboratory instrumentation.
• Review raw laboratory records, data calculations, and execution logs for absolute accuracy, protocol compliance, and strict adherence to Good Documentation Practices (GDP).
• Lead comprehensive Out-of-Specification (OOS) and laboratory deviation investigations, leveraging root-cause analysis tools to address complex non-conformances with minimal support.
• 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

• 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.

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 and overcome performance roadblocks without routine reminders.

Benefits

Compensation programs that recognize high performance
Medical, dental and vision insurance, as well as PTO and more
Full list of global benefits can be found here: https://www.lonza.com/careers/benefits

Pay

N/A

Schedule

Monday - Friday, 0800-1700