Title : Quality Assurance Auditor
Location : Shrewsbury, MA
Duration : 4 months (with possibilities of extension)
• Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures.
• Review SOPs, protocols/batch records, reports, and other quality and regulated records for accuracy, completeness, and compliance with all applicable regulations, international standards, and corporate policies and procedures.
• Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.
• Participate in the preparation and review of study/batch record and QA files in preparation for sponsor/client site visits; assure that QA audit files are retained. May participate in the hosting of client site visits and support regulatory inspections.
• Participate in the development of corrective and preventative actions to respond to client visit and regulatory inspection findings.
• Identify, document, and report deviations from regulations, protocols/batch records, SOPs, and specifications.
• Review protocols and batch records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures.
• Independently perform inspections and audits to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with regulations and international standards.
• Participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.
• Assist in scheduling and tracking QA audits, inspections and procedures as requested.
• Maintain written records for all statistical sampling and testing of product if tested in manufacturing areas.
• Participate in manufacturing line clearances and verification of room acceptability prior to product manufacture.
- Bachelor's degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.
- 1-2 years’ experience in QA role.