Endpoint Clinical · 1 month ago
Sr. Analyst, Quality Trust & Compliance
United States
Full-time
Remote
Mid, Senior Level
2+ years expEndpoint Clinical is focused on ensuring compliance for product release activities and post-launch processes. The Senior Analyst in Quality Trust & Compliance will oversee daily operations, provide guidance, and lead improvement projects related to compliance as mandated by regulatory agencies and the company's Quality Management System.
Clinical TrialsComputerCRMInformation TechnologyInnovation ManagementSoftware
Responsibilities
A primary point of contact for resourcing and guidance of product release team
Provide QTC review and approval of in-process tasks related to product and/or service provision
Develop and oversee onboarding and training of Analysts on QTC product release team
Act as subject matter expert and point of contact for Software Development Life Cycle process
Develop, write, and revise controlled Validation Deliverables and in continuous improvement efforts and procedures and practices related to product release
Provide ad hoc training to Operations staff on compliance procedures associated with product release
Responsible to perform the following QTC product release duties
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
Maintain validation documentation in QMS according with company procedures
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
Maintain validation documentation in QMS according with company procedures
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 as it relates to product release
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
Demonstrate efficient and accurate completion of all responsibilities
Qualification
Required
M.S. degree and minimum 2 years of related experience OR BS/BA degree and minimum 4 years of related experience
Minimum 2-4 years of relevant working experience within a regulated environment
Substantial working knowledge of 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
Strong communication (written and verbal), organizational, and interpersonal skills
Strong decision-making skills
Project management skills and high level of attention to detail
Demonstrated ability to work in a fast-paced, cross-functional team environment
Position requires a highly diplomatic and tactful individual with exceptional critical reasoning skills
Experience in developing SOPs in for quality assurance and compliance
Strong collaboration and development skills
Proactive team player enthusiastic with high work ethics
Proficient in Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point) and Adobe Acrobat Professional
Preferred
Certification in Quality Assurance or Regulatory Affairs
Relevant experience preferably in the clinical trial industry, IRT, or CRO experience
Experience with a QMS and LMS
Company
Endpoint Clinical
Endpoint Clinical designs, engineers, and tests interactive response technology platforms that enables data access through phones.
501-1000 employees
H1B Sponsorship
Endpoint Clinical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (10)
2023 (2)
2022 (7)
2021 (9)
2020 (9)
Funding
Current Stage
Late StageTotal Funding
$1.7M2024-03-11Acquired
2010-03-01Debt Financing· $1.7M
Leadership Team
Christine Oliver
CEO
Recent News
2025-08-13
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Company data provided by crunchbase