Lead a quality control team to ensure high standards of product quality and regulatory compliance at Thermo Fisher Scientific
Job Summary
Lead a quality control team to ensure high standards of product quality and regulatory compliance at Thermo Fisher Scientific.
Oversee microbiological testing activities including Bioburden, Sterility, Bacterial Endotoxin testing, and Growth Promotion testing while managing the release process.
Actively participate in regulatory inspections such as FDA and AIFA audits, ensuring audit readiness and responding to regulatory queries.
Matching Summary
Lead a quality control team to ensure high standards of product quality and regulatory compliance at Thermo Fisher Scientific.
Skills & Requirements
Must-have
GMP-regulated microbiology laboratory experience
Team leadership of 15+ analysts
Bioburden and Sterility testing expertise
FDA and AIFA inspection participation
Environmental monitoring program knowledge
Media Fill process simulation experience
Nice-to-have
Cross-functional collaboration skills
Continuous improvement initiative drive
Strong problem-solving capabilities
Effective communication with regulators
Key Requirements
Degree in Microbiology or related scientific discipline