Remote – US
endpoint is at the forefront of the evolving e-clinical technology industry with more than 20 years of experience designing, enhancing and deploying robust, configurable IRT solutions.
At our core is a commitment to the continuous evolution and enhancement of IRT to improve your trial management. Our unique, single-focus approach makes endpoint the only company with the knowledge and experience needed to drive IRT and e-clinical integration paradigm shifts in the industry.
Position: Release Analyst
The Release Analyst is primarily responsible for ensuring compliance for product release launch activities and post-launch compliance and ensuring compliance as set forth by regulatory agencies and endpoint Quality Management System (QMS).
- Provide QTC review and approval of in-process tasks related to product and/or service provision
- Generate, perform review, and maintain records of Validation Deliverables documentation and ensure compliance to procedures and processes
- Provide support to operations staff to develop, write, and revise controlled Validation Deliverables
- Act as primary QTC representative and resource to Operations staff with regards to product release
- Provide ad hoc training to Operations staff on compliance procedures associated with product release
- Assist with tracking and trending all KPIs (quality metrics) and conducting periodic Product Quality review with key stake holders
- Maintain validation documentation in QMS according with company procedures
- Coordinate record archival and retrieving at study closedown of live IRT products
- Assist in preparation, review, and maintenance of reports for identified product events
- Participate in Root Cause Analysis meetings with the Operational staff and provide input on the identification and documentation of Corrective Actions/ Preventive Actions for events of discrepancy or failure of released product
- Assist CAPA team in completion of outstanding CAPA items with the appropriate stakeholders
- Support the Governance unit in preparation for External Audits related to product release
- Perform QMS documentation Quality Control (QC) reviews on controlled documents such as SOPs, Work Instructions and Policies as well as provide feedback to key stakeholders as needed
Bachelor’s degree or relevant experience
- 1-2+ years of relevant working experience within a regulated environment
- Familiarity with some FDA regulations (21 CFR Part 11, EU Annex 11) regulations
- Knowledge of U.S. and international regulatory standards and guidelines preferred
- Experience with a QMS and LMS a plus