Essential Functions
• Responsible for performing and documenting analytical procedures in accordance with company procedures and regulatory guidelines.
• Assists in troubleshooting and process improvements to increase data quality, lower costs, or reduce turnaround times to include, updating standard procedures, assisting with troubleshooting.
• Acts as a technical resource for laboratory staff and support the team in the absence of the line manager.
• Performs routine data analysis to determine if an analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances.
• Identifies and documents potential performance errors or otherwise unusual results and escalates to senior lab personnel.
• Prepares data analysis results for upload to LIMS system under the guidance of senior level staff.
• Contributes to CAPA investigations, deviations, and resolution.
• Responsible for clear, accurate, and timely communications with cross functional stakeholders.
• Assists in maintaining laboratory equipment and may offer suggestions for new equipment.
• Assists in good housekeeping of the lab environment, consistent with 6S standards.
• Assists in maintaining adequate inventory.
• Responsible for preparation of buffers and solutions for analysis, as required.
• Performs and documents calibration and maintenance of laboratory equipment as assigned.
• Performs and documents hands on training for other lab personnel in areas of proven competency as assigned.
• Participates in continuing education through self-study, attending training sessions and lectures and meetings.
• May lead a laboratory or cross functional projects and assist with implementation of changes.
• May be responsible for contributing to the design and development execution of routine methods/assays under moderate supervision.
• Supports safety, quality, and 6S requirements and initiatives.
• Complies with company’s procedures and applicable regulatory requirements.