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Sr. Analyst, Quality & Compliance

1 month ago
United States
Full-time
Senior
QA Engineer
Quality Assurance and Testing
Apply Now
endpoint Clinical

endpoint Clinical

endpoint Clinical specializes in providing interactive response technology (IRT) systems that streamline clinical trial management for the life sciences industry, enabling study administrators to efficiently adjust parameters and manage clinical suppli...

Pharmaceuticals
251-1K
Founded 2009
View All Jobs 2

Description

  • Serve as the primary point of contact for resourcing, guidance, and product release matters for the Product Release team and Operations staff.
  • Review and approve in‑process tasks related to product and service provision and maintain/review validation documentation within the QMS.
  • Develop, draft, revise, and maintain controlled Validation Deliverables and related reports, and support Operations staff in their creation and revision.
  • Develop and oversee onboarding and training programs for Product Release Analysts and provide ad hoc compliance training to Operations staff.
  • Act as subject matter expert and primary contact for the Software Development Life Cycle (SDLC) process.
  • Drive continuous improvement of product release procedures and practices, including development of SOPs and quality documentation.
  • Participate in Root Cause Analysis (RCA) meetings and contribute to identification, documentation, and completion of Corrective and Preventive Actions (CAPA).
  • Assist the Governance unit in preparing for external audits related to product release activities.
  • Perform Quality Control reviews of controlled QMS documents (SOPs, Work Instructions, Policies) and provide feedback to stakeholders.

Requirements

  • M.S. degree with minimum 2 years related experience, OR BS/BA degree with minimum 4 years related experience.
  • Minimum 2–4 years of relevant experience in a regulated environment; experience in clinical trials, IRT, or CROs highly desired.
  • Substantial working knowledge of FDA regulations (21 CFR Part 11), EU Annex 11, and current industry best practices.
  • Knowledge of U.S. and international regulatory standards and guidelines.
  • Experience with Quality Management Systems (QMS) and Learning Management Systems (LMS) preferred.
  • Certification in Quality Assurance or Regulatory Affairs preferred.
  • Experience developing SOPs for quality assurance and compliance.
  • Strong written and verbal communication, organizational, interpersonal, decision‑making, and project management skills with a high level of attention to detail.
  • Demonstrated ability to work in a fast‑paced, cross‑functional environment and to apply diplomatic, tactful critical reasoning.
  • Proficient in Microsoft Office (Outlook, Word, Excel, Visio, Microsoft Project, PowerPoint) and Adobe Acrobat Professional.

Benefits

  • Salary range: $85,000 - $95,000 per year.
  • Full‑time employment.
  • Remote (US) role

Interested in this position?

Apply directly on the company website

Apply Now

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