Job Description

Quality Assurance Specialist will partner with team members across Quality Assurance, Quality Control, and Technical Operations to ensure effective, efficient, and compliant operations exist at client GxP sites in the Boston area.

• Responsible for oversight of facilities monitoring programs and data related to the Gene Therapy Manufacturing Facility.
• Ensure all data generated in support of the manufacturing operations and facility are appropriately generated, interpreted, and reported.
• Ensure raw materials sampling and testing programs are operating in an appropriate state for the product lifecycle stage.
• Facilitate resolution of facility excursions by leading the cross-functional review committee.
• Ensure oversight, maintenance, and approval of quality records for change control, deviation, CAPA, supplier quality management, documentation, training, and quality review.

Requirements:

• Minimum B.S. degree in an applicable discipline.
• 8-10 years of experience in biopharmaceutical or biotechnology based GMP clinical or commercial operations, within the Quality function.
• Comprehensive knowledge of FDA and EMA regulations and experience in US and international
• regulatory agency inspections.
• Experience with quality systems operations and supplier quality management.
• Experience in facilitation and leading continuous improvement efforts.
• Project management and meeting facilitation skills

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