Lab Tech Specialist For BSc Candidates at IQVIA – Apply Online

IQVIA Lab Tech Specialist For BSc Candidates – Apply Online

Lab Tech Specialist

Mumbai, India

Full-Time

Job Description

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 linearity and comparison studies, or other studies as required by various agencies and/or as requested by sponsors.
• Acts as technical SME to liaise with IT/systems teams to ensure appropriate functionality.
• Drafts new standard operating procedures (SOPs) and maintains 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 required.
• 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 the 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.

Reference: R1448284

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