Quality Control Analyst

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

Quality Control (QC) In-Process Analyst

Help Ensure Quality in Life-Saving Biopharmaceuticals

Are you passionate about Quality Control, analytical testing, GMP compliance, and biologics manufacturing? We're looking for a Quality Control (QC) In-Process Analyst to join a growing biopharmaceutical team supporting innovative biologic therapies.

If you thrive in a fast-paced QC laboratory environment and enjoy working with analytical testing, in-process sampling, endotoxin testing, and GMP documentation, this could be your next opportunity.

What You'll Do

• Perform in-process testing and sampling supporting 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 while ensuring compliance with written procedures
• Prepare study protocols, reports, test methods, and SOPs
• Support sample management, sample pickup, and sample tracking activities
• Collaborate with Manufacturing, Process Development, Validation, and Quality teams
• Support cGMP documentation, regulatory compliance, and continuous improvement initiatives

What We're Looking For

• Bachelor's degree OR 2-4+ years of biotech industry experience working in a QC or analytical laboratory required
• Must have experience with analytical testing, report writing, GMPs, and regulatory audits.
• Hands-on experience or exposure with:
  • Quality Control
  • In-Process Testing
  • Conductivity Testing
  • Osmolality Testing
  • Stability Studies

Bonus

• Experience troubleshooting and maintaining analytical instrumentation

$25.77 - $32.21 per hour (depending on experience and qualifications)

Benefits

• Health, Dental, and Vision Insurance
• 401(k) Matching
• Paid Time Off

Location & Availability

On-site in Tustin, CA

Overtime and weekend availability may be required

Applicants must already be authorized to work in the U.S.

If this sounds like you or someone in your network, I'd love to connect!

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