Quality Control In-Process Analyst

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

We are partnering with a leading biopharmaceutical manufacturing organization seeking a Quality Control In-Process Analyst to support manufacturing, validation, process development, and stability studies within a GMP-regulated environment. This role is responsible for performing analytical testing, sample collection, data analysis, and documentation activities that ensure product quality and compliance throughout the manufacturing process.

Key Responsibilities

• Perform analytical and compendial testing in accordance with established protocols and GMP requirements.
• Analyze test data, document results, and prepare reports with a high degree of accuracy.
• Conduct aseptic sampling and in-process testing, including pH, conductivity, osmolality, A280, endotoxin (LAL), and other quality control assays.
• Prepare buffers, reagents, and testing materials needed for laboratory operations.
• Perform water testing and raw material sampling and testing activities.
• Perform QC testing for lot release, stability, development/validation projects, and investigations.
• Write and revise test methods, standard operating procedures (SOPs), study protocols, and technical reports.
• Collaborate with cross-functional teams to develop, improve, and implement quality control procedures and policies.
• Ensure compliance with current Good Manufacturing Practices (cGMP), laboratory procedures, and applicable regulatory requirements.

Qualifications & Requirements

• B.S. degree in Biology, Chemistry, Biomedical Engineering, Chemical Engineering, or a related scientific discipline.
• 2+ years of experience in a biotechnology, pharmaceutical, or GMP-regulated laboratory setting.
• Must have experience with analytical testing, writing reports, GMPs, and regulatory audits.

This position is not eligible for visa sponsorship or support such as H1B, TN, E-3, CPT, OPT, STEM OPT, or employment‑based permanent residence processes, now or in the future.