Laboratory Technical Specialist

hace 1 día

Buenos Aires, Argentina Novasyte A tiempo completo

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.

LI-Remote

LI-MARIAARECHAGA

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.

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