In-Process QC Analyst — GMP & Lab Testing

BioTalent; Tustin (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

BioTalent is seeking a Quality Control In-Process Analyst to support manufacturing, validation, process development, and stability studies within a GMP environment. You will perform analytical testing, collect samples, analyze data, and document results to ensure product quality throughout the process.

The role requires aseptic sampling and in-process testing, including pH, conductivity, osmolality, A280, endotoxin (LAL), and other QC assays.

Qualifications

• B.S. degree in a science field (biology, chemistry, or related).
• 2+ years in biotech/pharma GMP lab.
• Experience with analytical testing, GMPs, and regulatory audits.

Responsibilities

• Perform analytical testing and compendial testing per GMP requirements.
• Analyze test data, document results, and prepare reports.
• Conduct aseptic sampling and in-process testing (pH, conductivity, osmolality, A280, endotoxin).
• Prepare buffers, reagents, and testing materials for laboratory operations.
• Perform water testing and raw material sampling and testing.
• QC testing for lot release, stability, development/validation projects, and investigations.
• Write and revise test methods, SOPs, protocols, and technical reports.
• Collaborate with cross-functional teams to improve QC procedures and policies.
• Ensure compliance with cGMP, lab procedures, and regulatory requirements.

Skills

Analytical testing

GMP compliance

Regulatory audits

Data analysis

Education

Bachelor's degree in Biology/Chemistry/ Biomedical Engineering/ Chemical Engineering

Job description

BioTalent is seeking a Quality Control In-Process Analyst to support manufacturing, validation, process development, and stability studies within a GMP environment. You will perform analytical testing, collect samples, analyze data, and document results to ensure product quality throughout the process.

The role requires aseptic sampling and in-process testing, including pH, conductivity, osmolality, A280, endotoxin (LAL), and other QC assays.