Location: Ubi.
Salary: Up to $3,800/month.
Working hours: Mon to Fri office hours.
Ensure compliance with federal, state, local regulations, and internal policies.
Conduct compliance assessments, including facility, equipment, and record inspections.
Review SOPs, protocols, batch records, and quality documents (deviations, CAPAs, etc.).
Support regulatory inspections and client audits by preparing relevant documentation and responses.
Contribute to corrective and preventive action (CAPA) recommendations.
Conduct internal facility inspections and maintain audit records.
Assist with reagent release activities and review of customer test reports.
Participate in the analysis of quality metrics via QMS and support Quality Management Reviews (QMRs).
Engage in process improvements, internal QA projects, and basic regulatory training.
Audit subcontractors, vendors, and suppliers, as needed.
Respond to customer regulatory inquiries in a timely manner.
Min.
Bachelor's degree, preferably in a life science discipline.
Min 2 years in a Quality Assurance role in a regulated environment (GLP/GMP/ISO preferred).