Job Overview

The Lab Technical Specialist performs procedures to monitor the performance and reporting of laboratory assays.

Essential Functions

• Develops and maintains the local laboratory Quality Control Program and database, performs statistical analysis of data and quality control performance data reviews in accordance with policy and regulatory guidelines.

• Validates assays through statistical analysis of local laboratory data, troubleshooting the effective implementation of analytical methods and the provision of technical information to relevant parties.

• Develops and maintains all aspects and phases of proficiency testing and accreditation programs for the local laboratory, including but not limited to enrollment, submission/review and investigations.

• Develops and maintains the yearly schedules for regulatory functions and performs data analysis for performing linearity and comparison studies, or other studies as required by various agencies and/or as requested by sponsors.

• Acts as technical SME to liase with IT/systems teams to ensure appropriate functionality.

• Drafts new standard operating procedures (SOPs) and the maintenance of existing SOPs related to the departmental activities on both a regional or global basis.

• Assists in process improvements and troubleshooting to improve efficiencies and quality delivery.

• Supports the Technical Services team in audits/inspections from regulatory agencies and pharmaceutical sponsors.

• Provides input and reviews local laboratory requirements for new studies, responds to technical inquiries and provides technical documents and data either directly or by maintaining study specific databases.

• May lead projects and assist with implementation.

• Supports safety and 6S requirements and initiatives.

• Participates in continuing education through self-study, attending training sessions and meetings.

Qualifications

• Bachelor's Degree in life sciences or other relevant field

• 1 year of experience in a clinical, research, academic or commercial/production laboratory environment.

• Knowledge of relevant regulatory agency standards.

• Knowledge of laboratory equipment, clinical laboratory assays, quality control and validation procedures.

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

• Proficiency with complex laboratory calculations including averages, means, standard deviations, and various quality control metrics.

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

• Effective organizational and interpersonal skills.

• Effective communication and presentation skills.

• Strong attention to detail and accuracy.

• Ability to work independently as well as in a team environment.

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

• Applicable certifications and licenses as required by local regulations.

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Q² Solutions, IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers

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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