An innovative life sciences company is hiring a Quality Specialist III to support product complaints, deviations, CAPAs, and quality events using the company’s eQMS. This role is key to maintaining GxP compliance and fostering a culture of continuous improvement.
Responsibilities
- Manage quality events and product complaints through eQMS workflows.
- Track and review investigations, deviations, and CAPAs.
- Evaluate root cause analyses and corrective/preventive actions.
- Communicate trends and metrics to stakeholders.
- Participate in internal audits and process improvement initiatives.
Requirements
- Bachelor’s degree in a scientific field.
- 5+ years of experience in a GxP-compliant environment, including QA or QC roles.
- Strong understanding of FDA/ICH regulations and CAPA processes.
- Experience using Veeva or similar quality management systems.
Preferred
- Certification in quality systems (e.g., Six Sigma, CQA).
- Experience in continuous improvement or operational excellence programs.