Lab Tech Specialist

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
Bachelors 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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