QC Analyst I - Biotech Quality & Compliance

Fleet Glass Services, Inc.; San Diego (CA); On-site; USD 60,000 - 80,000; Full time

Job summary

Nucleus Biologics, The Cell Performance Company, is a leading provider of custom cell-growth media and QC services. We are seeking a QC Analyst I to execute routine environmental monitoring, water testing, and in-process QC tasks in a fast-paced manufacturing lab in San Diego.

The role supports compliance with cGMP and ISO 9001/13485; duties include data entry, trending, investigations, and maintaining QC documentation. Strong organizational and communication skills are essential.

Qualifications

• Bachelor's degree required or equivalent combination of education and experience.
• 1-3 years of QC laboratory experience in pharma/biotech or related regulated industry.
• Cleanroom ISO Class 7/8 gowning experience required.
• Experience with environmental monitoring, water testing, or microbiological/chemical testing methods preferred.
• Familiarity with USP and cGMP; ISO 9001/13485 a plus.

Responsibilities

• Perform routine environmental monitoring of classified and non-classified areas (air, surface, and personnel).
• Perform personnel and environment monitoring during manufacturing runs.
• Conduct high-purity water testing in accordance with USP <645> and other applicable standards.
• Conduct testing of raw materials, in-process samples, and finished products to verify compliance with specifications and regulatory requirements.
• Support investigations of deviations, out-of-spec results, and non-conformances; document findings per procedures.
• Maintain accurate documentation of QC activities, testing, and analyses.

Skills

Attention to detail

Communication

Excel proficiency

Cross-functional work

Education

Bachelor’s degree in Chemistry, Microbiology, Biology, or related field

Tools

LIMS

Excel

Job description

Nucleus Biologics, The Cell Performance Company, is a leading provider of custom cell-growth media and QC services. We are seeking a QC Analyst I to execute routine environmental monitoring, water testing, and in-process QC tasks in a fast-paced manufacturing lab in San Diego.

The role supports compliance with cGMP and ISO 9001/13485; duties include data entry, trending, investigations, and maintaining QC documentation. Strong organizational and communication skills are essential.