A Quality Control Analyst in a biotech company ensures that products meet strict regulatory and safety standards by conducting rigorous testing and analysis. They perform laboratory experiments to detect contaminants, verify product consistency, and document results for compliance purposes. Their work supports the development and manufacturing of reliable biotech products, maintaining quality throughout the production process.
Conduct batch release testing of raw materials, intermediates, and final products.
Perform batch release testing to ensure raw materials, intermediates, and final products meet established quality standards and regulatory requirements. Utilize analytical techniques and standardized protocols to accurately verify product specifications before market distribution. Collaborate with cross-functional teams to troubleshoot discrepancies and maintain compliance with Good Manufacturing Practices (GMP).
Perform analytical assays (e.g., HPLC, GC, ELISA) to ensure product quality.
Conduct analytical assays such as HPLC, GC, and ELISA to accurately assess and maintain product quality according to industry standards. Analyze assay data to identify deviations and recommend corrective actions, supporting continuous improvement initiatives. Collaborate with quality control teams to ensure compliance with regulatory requirements and optimize testing protocols for enhanced efficiency.
Document test results and maintain accurate laboratory records.
Document test results with precision and maintain accurate laboratory records to ensure data integrity and compliance with regulatory standards. Employ standardized protocols for data entry and regularly review records for completeness and accuracy. Suggest implementing digital record-keeping systems to enhance traceability and efficiency in laboratory workflows.
Calibrate, operate, and maintain laboratory equipment and instruments.
Ensure precise calibration of laboratory equipment and instruments to maintain accuracy and reliability in test results. Operate various analytical devices following standard protocols, performing routine checks to identify inconsistencies or malfunctions. Maintain and troubleshoot instruments regularly to uphold optimal performance and compliance with safety standards.
Prepare and review Standard Operating Procedures (SOPs).
Prepare and review Standard Operating Procedures (SOPs) to ensure clear, precise, and compliant operational guidelines across all departments. Analyze existing processes, identify areas for improvement, and update SOPs to align with industry standards and regulatory requirements. Collaborate with cross-functional teams to validate procedures, enhance efficiency, and maintain thorough documentation for consistent organizational performance.
Investigate and report laboratory deviations or out-of-specification results.
Thoroughly investigate and document all laboratory deviations or out-of-specification (OOS) results to ensure compliance with regulatory standards and quality control protocols. Analyze root causes using robust scientific methods and collaborate with cross-functional teams to implement corrective and preventive actions. Maintain detailed records and generate comprehensive reports to support continuous improvement and regulatory audits.
Participate in validation and qualification of equipment, methods, and processes.
Participate in the validation and qualification of equipment, methods, and processes to ensure compliance with regulatory standards and operational efficiency. Collaborate with cross-functional teams to develop and execute validation protocols, identify deviations, and implement corrective actions. Maintain comprehensive documentation to support audit readiness and continuous improvement initiatives.
Ensure compliance with GMP, GLP, and other regulatory standards.
Maintain strict adherence to GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), and all relevant regulatory standards to guarantee product quality and safety. Conduct regular internal audits and implement corrective actions to address any compliance gaps effectively. Support cross-functional teams by providing expertise and training on regulatory requirements to sustain a culture of continuous improvement.
Perform environmental and microbial monitoring of production areas.
Conduct thorough environmental and microbial monitoring in production areas to ensure compliance with cleanliness standards and prevent contamination risks. Utilize advanced sampling techniques and data analysis tools to identify potential hazards and maintain product quality. Implement corrective actions based on monitoring results and collaborate with quality assurance teams to uphold regulatory requirements.
Collaborate cross-functionally with manufacturing, quality assurance, and R&D teams.
Collaborate cross-functionally with manufacturing, quality assurance, and R&D teams to drive product development and ensure compliance with industry standards. Leverage data analytics and process improvement techniques to enhance operational efficiency and maintain quality assurance. Provide technical support and coordinate project timelines to align with organizational goals and market demands.