QC Associate I – Biologics Analytical Testing

Abzena Inc.; San Diego (CA); On-site; USD 43,000 - 50,000; Full time

Job summary

Abzena Inc. in San Diego, CA is seeking a QC Associate I to perform analytical testing and support stability, qualification/validation, and release testing of biologics in a cGMP-regulated environment.

The role emphasizes data integrity, GDP compliance, and inspection readiness. The successful candidate will execute methods such as CE-SDS, Endotoxin, ELISA, UV-Vis, and compendial testing, maintain labs and records, and collaborate with QA, Manufacturing, and Materials Management to support

Qualifications

• Bachelor’s degree in biology, Biochemistry, Chemistry, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline required.
• 0–2 years of laboratory experience in biotechnology, pharmaceutical, or related industries.

Responsibilities

• Perform routine and non-routine analytical testing of in-process, release, stability, raw material, and investigational samples using approved methods and procedures.
• Execute analytical techniques for biologics, including CE-SDS, Endotoxin, Raw Material Testing, ELISA, UV-Vis, compendial testing.
• Maintain notebooks, worksheets, and electronic records in accordance with GDP and ALCOA+ data integrity principles.
• Support GMP documentation management, sample storage, inventory management, and materials ordering.
• Assist in internal and client audits, regulatory inspections, and quality assessments.

Skills

cGMP knowledge

0–2 years lab experience

Education

Bachelor’s degree in life sciences

Job description

Abzena Inc. in San Diego, CA is seeking a QC Associate I to perform analytical testing and support stability, qualification/validation, and release testing of biologics in a cGMP-regulated environment.

The role emphasizes data integrity, GDP compliance, and inspection readiness. The successful candidate will execute methods such as CE-SDS, Endotoxin, ELISA, UV-Vis, and compendial testing, maintain labs and records, and collaborate with QA, Manufacturing, and Materials Management to support