Laboratory equipment
• Serve as System Owner for assigned items of equipment;
• Manage and perform and/or support equipment and QC support systems qualification;
• Review calibration and maintenance activities and schedule needed work within the team while coordinating with clients as needed; and
• Maintain calibration laboratory and/or departmental accreditation, and quality systems. Perform laboratory and/or departmental administration and management.
Testing
• Manage and perform and/or support utility qualification, method qualification, verification and validation;
• Execute routine and non-routine testing procedures and assays;
• Create and review methods and procedures for completeness and accuracy;
• Maintain testing equipment at a high level to quality to ensure accuracy and consistency of test results
• Perform data analysis of testing results and communicate results to appropriate sources
Material/Data Management
• Responsible for documenting, computing, compiling, interpreting, reviewing, and entering data;
• Responsible for the inventory management of all media, and reagents used in QC testing;
• Partner with Subject Matter Experts and/or take responsibility for the design of special project studies;
• Ensure the timely disposal of tested samples and archive of retention samples;
Quality Assurance 质量要求
• Comply with the Company Quality Management Systems;
• Author new and revise documents, participate in investigation teams, and provide input to quality systems (change control, CAPA, and deviations); and
• Learn and comply with GLP and cGMPs, which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory log books.