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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.

Qualifications

• Bachelor's degree in healthcare-related fields.

• At least 1 year of experience in a regulated laboratory environment.

• Sound knowledge of principles, theories, and concepts in job area.

• Working knowledge of any applicable regulatory standards within area of responsibility.

• Proficiency with relevant laboratory techniques (Capillary Electrophoresis).

• Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling.

• Strong technical knowledge of complex testing procedures and science supporting the analysis.

• Proficiency with complex laboratory calculations regarding batches and specimens.

• Ability to troubleshoot laboratory equipment and resolve process issues.

• Good computer skills including proficiency with Microsoft Excel, PowerPoint and Word.

• Effective organizational and interpersonal skills.

• Effective communication and presentation skills.

• Capable of handling multiple tasks simultaneously.

• Strong attention to detail and accuracy.

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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