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Quality Control In-Process Analyst
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Based on California data
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What they do
A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
$67,470 / year median in California
-12% projected decline
Job Description
Quality Control In-Process Analyst at BioTalent Quality Control In-Process Analyst at BioTalent in Tustin, California Posted in about 18 hours ago.
Type:
full-time
Quality Control In-Process Analyst Location:
Tustin, CA About the Role 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.