Lab Tech Specialist
hace 2 semanas
**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 Biochemistry completed
- English Advanced
- 2+ years of previous experience in high-standard, globally recognized laboratory environments
- 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
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