Quality Control In-Process Analyst

BioTalent; Tustin (CA); On-site; USD 65,000 - 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-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.

Perform analytical testing, data analysis, and documentation to ensure product quality and regulatory compliance across

Qualifications

• 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.

Responsibilities

• Perform analytical and compendial testing per GMP and protocols.
• Analyze data, document results, and prepare reports.
• Conduct aseptic sampling and in-process testing (pH, conductivity, osmolality, A280, endotoxin).
• Prepare buffers, reagents, and testing materials.
• Perform water testing and raw material sampling and testing.
• QC testing for lot release, development/validation, 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

Data analysis

Documentation and reporting

Education

B.S. in Biology, Chemistry, Biomedical Engineering, or 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.