- Quality Assurance and Process Improvement
◦Demonstrate Quality training and ensure personnel understand and adhere to Quality requirements and SOPs
◦Lead process improvement initiatives
◦Lab Audits in compliance with GCP & SOP requirements
◦Experience in the document development process
◦Host site visits/inspections/audits as requested
◦Log and manage deviations, participate in the CAPA process, perform effectiveness checks
◦Participate in record review, including computer system validation
◾Serve as point of contact, responsible for managing, scheduling, and documenting activities, site audits, and reports
◾Perform administrative updates to protocols in conjunction with Principal Investigators
◾Assists with maintenance of the occupational health program
◾Serve as a resource to departments to maintain a safe working environment - identifying hazards, risks, and appropriate mitigation
◾Identify processes to meet Federal, state and local regulatory requirements, such as EPA, OSHA, MDE, including reporting in accordance with timelines
- BS/BA degree.
- Certification preferred, not required
- Demonstrated comprehensive knowledge of and experience in quality assurance and process improvement.
- Experience in regulatory and compliance aspects of clinical laboratory and/or in vivo
Sthree US is acting as an Employment Business in relation to this vacancy.