Biologics QC Analyst I – Growth Path

Abzena

San Diego (CA)

On-site

USD 43,000 - 50,000

Full time

6 days ago
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Job summary

Abzena, located in San Diego, CA, seeks a QC Associate I to support stability, qualification/validation, and release testing of biologics in a cGMP environment. The role covers routine QC operations, data review, inventory management, and improvement initiatives to maintain inspection readiness and regulatory compliance.

The successful candidate will have a relevant science degree and 0–2 years of biotech laboratory experience, with hands-on testing using ELISA, CE-SDS, endotoxin assays, UV-Vis,

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 commonly used for biologics and large‑molecule products: CE‑SDS, Endotoxin, Raw Material Testing, ELISA, UV‑Vis Spectroscopy, Compendial testing.
  • Maintain notebooks, worksheets, logbooks, and electronic records per GDP and ALCOA+ data integrity.
  • Ensure GMP, ALCOA+ compliance and regulatory requirements.

Skills

Analytical testing
Laboratory documentation
Data integrity
Quality systems (cGMP/ALCOA+)
Cross-functional collaboration

Education

Bachelor’s degree in biology/biochemistry/chemistry/pharmaceutical sciences/biotechnology or related

Tools

ELISA
UV-Vis Spectroscopy
Endotoxin testing

Job description

Abzena, located in San Diego, CA, seeks a QC Associate I to support stability, qualification/validation, and release testing of biologics in a cGMP environment. The role covers routine QC operations, data review, inventory management, and improvement initiatives to maintain inspection readiness and regulatory compliance.

The successful candidate will have a relevant science degree and 0–2 years of biotech laboratory experience, with hands-on testing using ELISA, CE-SDS, endotoxin assays, UV-Vis,

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