QA Specialist IV

QA Specialist IV

• On-site
• Swansea, MA area

• Support Phase I/II Clinical Manufacturing Campaigns and Clinical Shipments

Perform data and document review for Batch Records, Solution Records, Test Records, Stability and Validation documents
• Perform review of INDs for submission
• Write, review, and approve SOPs, batch records, material specs and test record
• Conduct audits (Internal, Vendors, Suppliers, Sub-Contractors Testing Facilities, and Clinical)
• Review and approve Quality System documentation
• Trend and report QA related information (Deviations, CAPAs, EM excursions, Non-conformances, Change Controls etc.)
• Assist with disposition of Clinical Product and Cell Banks

Oversee Environmental Monitoring Alert/Action Program
• Support the stability program through review of protocols, reports, and data
• Confirm Clinical Site Essential Documents are in place for initial drug supply shipments
• Perform PCO and Area Clearance responsibilities for MFG and MM processes
• Review and approve protocols including Manufacturing, Test Method, Equipment (IQ, OQ, and Process Validation, Cleaning Validation) etc.
• Review method and process reports for compliance
• Raw material review and disposition
• MS review and approval

Assignment of equipment numbers and review of Calibration certificates and OOTs

• Bachelor Science degree in Chemistry/Biology or related discipline
• 6+ years QA experience in Biotech/Pharma industry or combination of QA/MFG or QC experience
• Strong understanding of QC test methods, stability procedures and environmental monitoring programs