Biologics QC Analyst I/II — GMP Lab

Abzena; San Diego (CA); On-site; USD 55,000 - 83,000; Full time

Job summary

Abzena in San Diego, CA, is seeking a QC Associate I/II to perform analytical testing in a cGMP-regulated environment, supporting stability, qualification/validation, and release testing of biologics. You will execute methods, review data, and help maintain inspection readiness.

The role requires hands-on HPLC/UPLC, CE-SDS, cIEF/icIEF, ELISA, UV-Vis, and compendial testing, with emphasis on data integrity and GDP/ALCOA+ data standards.

Qualifications

• Bachelor’s degree in chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific field.
• 3–7+ years of experience in GMP Quality Control laboratory environment.
• Hands-on experience with HPLC/UPLC systems and chromatography data systems.
• Direct experience with Empower CDS or LIMS implementation preferred.
• Strong understanding of GMP regulations and data integrity expectations.

Responsibilities

• Perform routine and non-routine analytical testing of in-process, release, stability, characterization, reference standard, raw material, and investigational samples using approved methods and procedures.
• Execute a variety of analytical techniques commonly used for biologics and large-molecule products, including HPLC/UHPLC, CE-SDS, cIEF/icIEF, ELISA, UV-Vis, compendial testing.
• Maintain laboratory notebooks, worksheets, logbooks, and electronic records in accordance with GDP and ALCOA+ data integrity principles.
• Review and support validation documentation, test scripts, and execution records. LIMS knowledge is a plus.
• Support analytical method transfer, qualification, verification, and validation activities from Analytical Development or external clients into GMP QC laboratories.
• Participate in laboratory investigations involving OOS, OOT, invalids, and other lab investigations as needed.
• Maintain laboratory equipment records and ensure equipment remains in a qualified state.
• Support laboratory readiness for internal audits, client audits, regulatory inspections, and quality assessments.
• Collaborate effectively with cross-functional teams including QA, AMD, Manufacturing, MSAT, and Materials Management.
• Support implementation of new technologies, systems, and laboratory processes.

Skills

GMP knowledge

Data integrity

Analytical problem solving

Independent worker

Regulatory awareness

Education

Bachelor’s degree in chemistry, Biochemistry, Pharmaceutical Sciences, or related field

Tools

Empower CDS

LIMS

OpenLab

ChemStation

Job description

Abzena in San Diego, CA, is seeking a QC Associate I/II to perform analytical testing in a cGMP-regulated environment, supporting stability, qualification/validation, and release testing of biologics. You will execute methods, review data, and help maintain inspection readiness.

The role requires hands-on HPLC/UPLC, CE-SDS, cIEF/icIEF, ELISA, UV-Vis, and compendial testing, with emphasis on data integrity and GDP/ALCOA+ data standards.