Act as a specialist for the local laboratory quality and technical systems including assay quality control, proficiency testing review, assay validations, instrument qualification and/or the scientific database, collaborating with Global Lab Harmonization, Assay Development Laboratory, Scientific Review, Data Management, Quality Assurance, Information Technology teams and Vendors as necessary in the execution and fulfillment of duties.
- Provides input into Global Laboratory Harmonization 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.
- Monitors the local Technical Support Helpdesk, responding to inquiries from other departments and clients requesting specific laboratory information.
- Develops and maintains the local laboratory Quality Control Program and database, performs statistical analysis of data and quality control performance data reviews and purchases and distributes quality control materials in accordance with Global Lab Harmonization policy and regulatory guidelines.
- Provides input into Global Laboratory Harmonization and validates (new) 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.
- Performs system lifecycle activities and associated deliverables pertaining to local laboratory instruments and equipment, including but not limited to the testing, and execution of validation activities, calibration, maintenance, change control and retirement activities. Responsible for the renewal of laboratory instrumentation and equipment service contracts as well as assisting on-site vendor maintenance procedures per contract agreement.
- Provides technical information to other departments 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.
- Provides input into Global Laboratory Harmonization and may draft new standard operating procedures (SOPs) and the maintenance of existing SOPs related to the departmental activities on both a regional or global basis.
- Represents Technical Services team in audits/inspections from regulatory agencies and pharmaceutical sponsors
Minimum required education and experience
- Bachelor’s Degree in life sciences or other relevant field required
- 1 year relevant clinical laboratory experience required or equivalent combination of education, training and experience
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