Senior Quality Assurance Specialist

Role: Senior Quality Assurance Specialist focused on maintaining and improving quality systems within a biopharma or IVD manufacturing environment. Objectives include ensuring compliance with ISO 13485, FDA Quality System Requirements, and regulatory standards through audits, documentation, and validations. Responsibilities encompass document control, conducting internal audits, preparing reports, supporting batch record review and material disposition, managing CAPAs and nonconformances, and contributing to validation activities. Qualifications: B.S. or B.A. in science or engineering; minimum 3 years in QA; certifications such as ASQ CQE, CQA, or Lead Auditor preferred. High-value: experience with document control, GxP/QMS compliance, audit leadership, CAPA management, risk management under ISO 14971, validation protocols, and statistical analysis; familiarity with electronic databases; ability to work in a lab/production setting; physical ability to handle materials and perform extended tasks; onsite work with standard hours. Collaboration involves QA team, production, and regulatory functions, with reporting to QA management.