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Form of workJob Description
Job Description:
- We are focused on generating and activating data from a variety of sources, including clinical, social, behavioral and the real world, to arrive at the best solutions for a person based on a comprehensive view of the evidence. Our unique expertise and capabilities in technology, data science and healthcare enable the entire healthcare ecosystem to drive better health outcomes.
- As a GLP/GCLP Quality Professional at client, you will work with the organization to act as a champion of Quality Assurance activities for development and commercial laboratory services and projects.
- You will support the implementation and maintenance of quality programs, systems, and operations related to Good Laboratory Practices (GLP) and Good Clinical Laboratory Practices (GCLP).
- You will help develop phase-appropriate quality strategies during different phases of product development, from research to pre-clinical and clinical phases.
- You hold your work and teams to the highest quality standards and ensure that all corporate business requirements, regulations, and other standards are met as applicable.
- This is a hands-on role where you will apply intensive, self-directed, and diversified knowledge of laboratory and quality principles for client’s programs and platforms.
- Someone who can understand, and able to train and monitor.
- Someone who can conduct lab trainings and write SOP's.
- Required minimum 7+ years of experience.
- Guide and train laboratory personnel in adhering to GLP/GCLP, when applicable.
- Review and approve laboratory procedures, changes to LIMS, and data.
- Facilitate phase appropriate GxP compliance for test method development and validation; sample handling, processing, and storage; equipment calibration and maintenance; data integrity; and documentation.
- 5+ years of experience in R&D Quality or product development in the pharmaceutical, biotech, life sciences, or clinical research industries.
- Expertise in GLP or GCLP highly preferred.
- Experience with Laboratory Quality Management Systems (QMS) and LIMS Knowledge of ISO/IEC 17025 – Testing and Calibration Laboratory Requirements.
- Experience in project management, training, and working collaboratively with product development teams.
- GLP/GCLP
- Quality Management Systems (QMS)
- LIMS
- Laboratory
- BA/BS degree in science, life sciences, related technical field, or equivalent practical experience.
