Biotech QC In-Process 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

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.