Lab Tech Specialist
Buenos Aires, AR
hace 2 días
source : DirectEmployers Association

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.

Job OverviewThe Sr Lab Technical Specialist acts as a technical lead to perform and monitor the performance and reporting of laboratory assays.Essential Functions

  • Leads and develops the execution of local laboratory technical support, communicates with and provides guidance and relevant test data to stakeholders.
  • Develops and lead the local laboratory quality program and database, performs statistical analysis of data and quality control performance data reviews in accordance with policy and regulatory guidelines.
  • Develops and lead in validation of assays through statistical analysis and troubleshooting of local laboratory data, and acts as a technical specialist for stakeholders in the effective implementation of analytical methods in the local lab.
  • Develops, leads and acts as contact person on all aspects and phases of proficiency testing and accreditation programs within the local lab.
  • Coordinate resolution of deficiencies with lab operations. Identifies and drives preventative actions.

  • Develops and leads the yearly schedules for the local laboratory for regulatory functions and completes data analysis by 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.
  • Mentors new hires within the department. Responsible for the completion of competency forms and associated documentation related to their training activities.
  • Initiates, leads and communicates on a technical level with manufacturers, global organizational colleagues and / or System Compliance Office related to their daily activities on both a regional or global basis.
  • Drafts new standard operating procedures (SOPs) and the maintenance of existing SOPs related to the departmental activities on both a regional or global basis.
  • Coordinates with global labs to ensure harmonization. Leads periodic review process for SOPs.

  • Represents Technical Services team in audits / inspections from regulatory agencies and pharmaceutical sponsors of the local laboratory.
  • Identifies and leads continuous process improvement initiatives to enhance effectiveness, quality, and productivity.
  • Leads projects and drives implementation of changes and enhancements.
  • 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 Req
  • 4 years of experience in a clinical, research, academic or commercial / production laboratory environment.
  • Sound knowledge of relevant regulatory agency standards.
  • Sound 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.
  • Demonstrated experience in effectively communicating technical information to clients.
  • Good computer skills including proficiency with Microsoft Excel, PowerPoint and Word.
  • Excellent oral and written communication skills.
  • Strong organizational skills, and close attention to detail are essential.
  • Capable of handling multiple tasks simultaneously and independently.
  • Demonstrated "everyday leadership" skills.
  • Ability to maintain a minor degree of independence to complete assigned tasks and projects.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Ability to synthesize information from various topics.
  • Ability to bring projects and deliverables to completion under timeline expectations.
  • Applicable certifications and licenses as required by local regulations.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.EEO Minorities / Females / Protected Veterans / Disabled

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