Quality Assurance Associate

The Quality Assurance Associate is responsible for supporting and enhancing the Quality Management System (QMS) in compliance with ISO/IEC 17025 and 21 CFR Part 58 (GLP) standards. This role involves managing controlled documentation, overseeing change control processes, conducting internal audits, and participating in continuous improvement and corrective action initiatives to ensure regulatory and policy compliance.

• Oversee and maintain QMS documentation, ensuring compliance with relevant regulatory standards and internal policies.
• Manage document control processes, including creation, review, approval, revision, distribution, and archival of controlled documents.
• Coordinate and track document change requests, ensuring proper workflows and approvals are followed.
• Conduct periodic reviews and updates of quality manuals, SOPs, work instructions, and related records.
• Plan, schedule, and perform internal audits to assess compliance with ISO/IEC 17025 and GLP requirements.
• Document audit findings, communicate results to relevant stakeholders, and verify the effectiveness of corrective actions.
• Support external assessments, accreditation activities, and customer or regulatory audits as needed.
• Assist with CAPA activities, nonconformance management, and continuous improvement initiatives within the quality system.

• Bachelor's degree in Life Sciences, Chemistry, Biology, or a related field preferred; equivalent education and experience considered.
• 2-5 years of experience in Quality Assurance, Quality System audits, or Document Control.
• Experience administering QMS in laboratory, testing, calibration, manufacturing, or regulated environments.
• Experience conducting internal audits and supporting CAPA, nonconformance management, and root cause analysis preferred.
• Strong understanding of ISO/IEC 17025, GLP requirements, and quality management principles.
• Working knowledge of document control systems and electronic QMS platforms.
• Excellent document organization, records management, and analytical skills.
• Effective written and verbal communication abilities; strong problem-solving and investigative skills.
• Ability to manage multiple priorities with attention to detail.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Experience with Quality Management Software (QMS/eQMS) preferred.
• ISO/IEC 17025 Internal Auditor Certification preferred.
• ASQ Certified Quality Improvement Associate (CQIA) or Certified Quality Auditor (CQA) preferred.