Remote
Endpoint Clinical

Release Analyst

Remote – US

About 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

Position Overview:

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).

Responsibilities:

  • 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

Education:

Bachelor’s degree or relevant experience

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