Senior Quality & Compliance Analyst, Product Release

Endpoint Clinical, inc.; Durham (NC); On-site; USD 85,000 - 95,000; Full time

Job summary

A life sciences solutions provider is seeking a Senior Quality & Compliance Analyst to oversee compliance for product releases and ensure adherence to regulatory standards. Responsibilities include training for the Product Release team, approving processes, and maintaining documentation within the Quality Management System. The ideal candidate holds a relevant degree and has 2-4 years of experience in a regulated environment, with strong communication and project management skills. Compensation ranges from $85,000 to $95,000 annually.

Qualifications

• Minimum 2-4 years of working experience within a regulated environment.
• Substantial knowledge of FDA regulations (21 CFR Part 11, EU Annex 11).
• Knowledge of U.S. and international regulatory standards.

Responsibilities

• Serve as the primary point of contact for the Product Release team.
• Review and approve in-process tasks related to product/service provision.
• Develop onboarding and training programs for Analysts on the team.

Skills

Strong communication (written and verbal)

Organizational skills

Interpersonal skills

Project management skills

Attention to detail

Critical reasoning skills

Team collaboration skills

Proficient in Microsoft Office

Education

M.S. degree with minimum 2 years experience or BS/BA degree with minimum 4 years experience

Certification in Quality Assurance or Regulatory Affairs (preferred)

Tools

Quality Management System (QMS)

Learning Management System (LMS)

Microsoft Office (Outlook, Word, Excel, Visio, Project, PowerPoint)

Adobe Acrobat Professional

Job description

A life sciences solutions provider is seeking a Senior Quality & Compliance Analyst to oversee compliance for product releases and ensure adherence to regulatory standards. Responsibilities include training for the Product Release team, approving processes, and maintaining documentation within the Quality Management System. The ideal candidate holds a relevant degree and has 2-4 years of experience in a regulated environment, with strong communication and project management skills. Compensation ranges from $85,000 to $95,000 annually.