Sr Lab Tech Specialist, Q2 Solutions
hace 2 semanas
The
Sr Lab Technical Specialist acts as a technical lead to perform and monitor the performance and reporting of laboratory assays.
CV must be submitted in English.
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.
- 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.
- Identifies and leads continuous process improvement initiatives to enhance effectiveness, quality, and productivity.
Qualifications
- Bachelor's Degree in life sciences (
Biochemist ideally) or other relevant field. - 4 years of experience in a clinical, research, academic or commercial/production laboratory environment. For example, working as a
Biochemist in a site (Hospital). - Good computer skills including proficiency with Microsoft Excel, PowerPoint and Word.
- Excellent oral and written communication skills.
- Advanced level of
English skills. - Strong organizational skills, and close attention to detail are essential.
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