Role Summary
This role is responsible for ensuring products meet the highest regulatory and company standards. The Senior Microbiologist will coordinate a team of operators and technicians within Quality Control Laboratory, ensuring compliance with microbiology standards, cleanroom requirements and GLP.
The incumbent will lead and execute microbiology activities and investigations related to product sterilization, leading root cause investigations for product failures, and maintaining laboratory safety and equipment readiness for internal, customer or regulatory inspections.
Key Responsibilities:
1. Coordinate and execute microbiology activities and investigations related to product sterilization
2. Ensure all work complies with regulatory standards, company policies and SOPs
3. Lead, develop and manage a team of quality operators and technicians in the Quality Control Lab
4. Oversee compliance with ETO sterilization, microbiology and GLP
5. Maintain and improve Cleanroom standards, ensuring compliance at all times
6. Lead root cause investigations for product failures
7. Support sterilization-related inquiries
8. Maintain laboratory safety and equipment readiness for internal, customer or regulatory inspections
9. Manage dose establishment, dose audits and report preparation for the department
10. Review product lots and approve them for release, ensuring compliance with quality standards
11. Collaborate with technical specialist groups and integrate their insights into quality processes
Requirements:
* Bachelor's degree in Science or related field, with specialization in Microbiology
* At least four years of experience in the healthcare industry, specifically in pharmaceuticals, biotech or medical devices
* Hands-on laboratory experience and deep understanding of ETO sterilization and microbiology
* Knowledge of ISO 9001/2000 or ISO 13485 standards and FDA regulations
* Experience in process validation, cleanroom operations and CAPA system management
* Excellent interpersonal and communication skills, with proven success in cross-functional team environment
* Ability to work in Lean Manufacturing environment, driving continuous improvement