Biotech QC In-Process Analyst Impact in Biologics

BioTalent; Tustin (CA); On-site; USD 73,977,000 - 92,230,000; Full time

Benefits offered by this job

Health, Dental, and Vision Insurance

401(k) Matching

Paid Time Off

Job summary

BioTalent is seeking a Quality Control (QC) In-Process Analyst to join a biopharmaceutical team in California. The role focuses on in-process sampling, endotoxin and LAL testing, buffer preparation, and GMP documentation to support manufacturing, validation, and development projects.

You will collaborate with Manufacturing, Process Development, Validation, and Quality teams to ensure cGMP compliance and continuous improvement across QC activities.

Qualifications

• Bachelor's degree OR 2-4+ years biotech industry experience in QC/analytical lab.
• Experience with analytical testing, GMPs, and regulatory audits.
• Hands-on exposure to in-process testing and related QC activities.

Responsibilities

• Perform in-process testing and sampling to support manufacturing, validation, process development, and stability studies.
• Support endotoxin, pH, conductivity, osmolality, A280, and LAL testing activities.
• Formulate buffers and reagents for laboratory testing.
• Perform water testing, raw material sampling, and material evaluations.
• Support QC testing for lot release, stability, development, validation projects, and investigations.
• Review and analyze laboratory data per written procedures.

Skills

Quality Control

In-Process Testing

Endotoxin Testing

Conductivity Testing

Osmolality Testing

Stability Studies

Education

Bachelor's degree OR 2-4+ years biotech QC experience

Job description

BioTalent is seeking a Quality Control (QC) In-Process Analyst to join a biopharmaceutical team in California. The role focuses on in-process sampling, endotoxin and LAL testing, buffer preparation, and GMP documentation to support manufacturing, validation, and development projects.

You will collaborate with Manufacturing, Process Development, Validation, and Quality teams to ensure cGMP compliance and continuous improvement across QC activities.