Senior Lab Tech Specialist
Act as a lead for the local laboratory quality and technical systems including validation, quality control, proficiency testing, metrology and/or technical support aspects of the local clinical laboratory, collaborating with Global Harmonisation, Assay Development Laboratory, Scientific Review, Data Management, Quality Assurance, Information Technology teams and Vendors as necessary in the execution and fulfillment of duties.
This job description reflects major responsibilities globally and is not intended to reflect all possible duties and responsibilities for each employee in this job title. Management has the right to assign all or a portion of the duties and responsibilities of this job based upon business needs.
- Mentor new hires within the department. Responsible for the completion of competency forms and associated documentation related to their training activities.
- Lead and develop the execution of local laboratory technical support, communicates with and provides guidance and relevant test data to stakeholders.
- Oversee the local laboratory Technical Support Helpdesk staff with inquiries from other departments and clients requesting specific laboratory information.
- Develop and lead the local clinical laboratory quality program including statistical analysis, by providing guidance to laboratory staff and communicating with laboratory management, global quality control and global lab harmonization groups as required.
- Develop and lead in validating (new) 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.
- Develop, lead and act as contact person on all aspects and phases of proficiency testing and accreditation programs within the local lab.
- Develop and lead 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.
- Responsible for all system lifecycle activities and associated deliverables pertaining to local laboratory instruments and equipment, including the design, testing, and execution of qualification activities, calibration, maintenance, change control and retirement activities, to ensure effective implementation and maintenance of local laboratory instruments and equipment to the highest standard.
- Initiate, lead and communicate 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.
- Work with Global Lab Harmonization to initiate the drafting of new standard operating procedures (SOPs) and the maintenance of existing SOPs related to the departmental activities on both a regional or global basis.
- Represent Technical Services team in audits/inspections from regulatory agencies and pharmaceutical sponsors of the local laboratory
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Knowledge of clinical laboratory regulations, GxP and /or ICH guidelines
- Knowledge of laboratory equipment, clinical laboratory assays, quality control and validation procedures
- Proficiency in PC applications such as word processing, spreadsheets, database management
- Excellent attention to detail, organizational skills, verbal and written communication skills
- Ability to work independently as well as in a team environment
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
EEO Minorities/Females/Protected Veterans/Disabled
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