The Quality Associate 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).
*This position can be based remotely, East & Central Coast preferred.
- 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
- 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
- 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
- Support the Governance unit in preparation for External Audits related to product
- 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
- Bachelor’s degree in related scientific or technical discipline
- 1-2 years of relevant working experience within a regulated environment
- Familiarity with FDA regulations (21 CFR Part 11, EU Annex 11) regulations and current industry best practices.
- Knowledge of U.S. and international regulatory standards and guidelines
- Experience with a QMS and LMS a plus, but not required
- Strong communication (written and verbal), organizational, and interpersonal skills.
- Project management skills and high level of attention to detail.
endpoint is an equal opportunities employer AA/M/F/Veteran/Disability.
Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.