Senior Quality Associate, Sterility Assurance

Role Summary

Senior Quality Associate, Sterility Assurance

Responsibilities

• Serve as the primary technical expert in contamination control, aseptic processing, and sterilization, providing guidance and support to manufacturing operations and ensuring adherence to regulatory requirements and industry best practices.
• Lead and oversee the validation and qualification of facilities, processes, equipment, and systems related to sterility assurance, including aseptic processing, media fills, and sterilization cycles.
• Identify and troubleshoot issues related to sterility assurance, conduct root cause analyses, implement corrective actions, and drive continuous improvement initiatives to minimize process risks and optimize productivity.
• Develop and deliver comprehensive training programs for operators, technicians, and other relevant personnel on sterility assurance principles, best practices, and regulatory requirements.
• Ensure compliance with all applicable regulations and industry standards, prepare for and support regulatory inspections, and act as a subject matter expert during audits.

Qualifications

• B.S. in related field (Microbiology, Biology, etc.) or equivalent experience in lieu of degree
• 3+ years‚Äô experience with sterile manufacturing
• Familiarity with Global Regulatory Standards FDA, EU GMP, USDA, CFIA, as applicable
• Experience with a variety of technologies and platforms is preferred including poultry vaccine technologies, recombinant protein platforms, protein-based therapeutics, cell culture and fermentation technology

Skills

• Contamination control
• Aseptic processing
• Sterilization
• Regulatory inspections
• Training program development
• Root cause analysis

Education

• B.S. in related field or equivalent practical experience