Senior QC Analyst, Analytical - cGMP Release & Validation

Lonza Inc.; Portsmouth (VA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

PTO

Benefits portal

Job summary

Lonza Inc. in Portsmouth, NH, is seeking an experienced QC Analyst III to join the Analytical team in a large-scale allogenic manufacturing environment.

The role focuses on advanced cGMP release testing, method validation, and robust investigations, with opportunities to train others and influence continuous improvement. You will work under supervision to ensure compliant testing, accurate data review, and timely product release, leveraging Flow Cytometry, ELISA, and PCR techniques.

Qualifications

• 3–4+ years of direct Quality Control laboratory experience in a cGMP biomanufacturing or regulated clinical testing setting.
• Hands-on experience with cell culture maintenance, immunophenotyping via flow cytometry, PCR, and immunological assays.
• Familiarity with LIMS and quality systems software (e.g., TrackWise) preferred.

Responsibilities

• Execute complex cGMP release testing to support on-time product release.
• Lead assay transfer, qualification, and validation activities.
• Review raw data and logs for accuracy and GDP compliance.
• Own OOS investigations and root-cause analyses.
• Prepare and coordinate CAPAs and change controls.
• Develop and maintain SOPs, forms, and test records.
• Train junior QC staff and escalate laboratory issues to management.

Skills

cGMP testing

Flow cytometry

ELISA

PCR

Cell culture

GDP

Data review

Change control

CAPA

Documentation

Education

Bachelor’s in Biochemistry/Biology

Tools

LIMS

TrackWise

Job description

Lonza Inc. in Portsmouth, NH, is seeking an experienced QC Analyst III to join the Analytical team in a large-scale allogenic manufacturing environment.

The role focuses on advanced cGMP release testing, method validation, and robust investigations, with opportunities to train others and influence continuous improvement. You will work under supervision to ensure compliant testing, accurate data review, and timely product release, leveraging Flow Cytometry, ELISA, and PCR techniques.