Quality Control Analyst

BioTalent; Tustin (CA); On-site; USD 36,000 - 44,000; Full time

Benefits offered by this job

Health, Dental, Vision Insurance

401(k) Matching

Paid Time Off

Job summary

BioTalent in Tustin, CA is seeking a Quality Control (QC) In-Process Analyst to support in-process sampling, analytical testing, endotoxin testing, and GMP documentation in a fast-paced biopharma lab environment.

The role involves collaborating with Manufacturing, Process Development, Validation and Quality teams to perform in-process tests, prepare SOPs, and ensure data integrity for lot release, stability, investigations, and product development.

Qualifications

• Proficient in analytical testing and report writing.
• Experience with GMPs and regulatory audits is required.
• Hands-on exposure to QC lab techniques and instrumentation.

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 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.

Skills

In-Process Testing

Analytical Testing

GMP Documentation

Data Review

Education

Bachelor’s degree

2–4+ years biotech 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

Please Note

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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