QC Analyst II, Analytical - LSA

Lonza•Portsmouth, NH

5d•Onsite

About The Position

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.

Requirements

2–4 years of direct Quality Control laboratory experience within a cGMP biomanufacturing or regulated clinical testing setting is required.
Proven, hands-on experience performing cell culture maintenance, immunophenotyping panels via flow cytometry, PCR amplification, and standard immunological assay techniques.
Demonstrated ability to actively participate in laboratory event investigations, formulate root-cause theories, and write clear, logical technical summaries.
Bachelor’s Degree in Biochemistry, Biology, or a closely related technical science discipline is required.
Superior written and oral communication skills, a solutions-focused team attitude, and the personal initiative required to navigate multiple testing demands without routine reminders.

Nice To Haves

Familiarity with Laboratory Information Management Systems (LIMS), enterprise data management applications, and quality systems software (such as TrackWise) is highly preferred.
A Master’s Degree in a scientific discipline is preferred.

Responsibilities

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.
Actively support analytical method transfer, verification, and validation activities to successfully onboard new client processes into the testing facility.
Review raw laboratory records, data calculations, and execution logs for absolute accuracy, protocol compliance, and strict adherence to Good Documentation Practices (GDP).
Initiate and author comprehensive Out-of-Specification (OOS) and laboratory deviation investigations, leveraging root-cause analysis tools to address non-conformances with proper support.
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.
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.
Maintain laboratory benches, calibrate specialized analytical instrumentation, and propose workflow efficiency upgrades during process improvement events.