The role involves environmental monitoring of cleanrooms and utilities in line with ISO 14644 standards and applying cGLP to all laboratory activities
Job Summary
The role involves environmental monitoring of cleanrooms and utilities in line with ISO 14644 standards and applying cGLP to all laboratory activities.
The Senior Staff Microbiologist leads non-conformance and CAPA generation and resolution, performs sterility release reviews, and continually identifies opportunities for process stabilization and cost savings.
The position requires mentoring and training team members and cross-functional groups, acting as a subject matter expert to develop and improve policies and procedures aligned with industry best practices and regulatory requirements.
Matching Summary
The role involves environmental monitoring of cleanrooms and utilities in line with ISO 14644 standards and applying cGLP to all laboratory activities.
Skills & Requirements
Must-have
Environmental monitoring of cleanrooms
Application of cGLP in laboratory
Statistical data analysis and trending
NC and CAPA generation and resolution
Sterility release review and interpretation
Supplier maintenance and support
Project management in matrix organization
Nice-to-have
Meticulous documentation skills
Self-directed and proactive work style
Mentoring and training cross-functional teams
Strong interpersonal and communication skills
Critical and outside-the-box thinking
Experience with compliance risk situations
Key Requirements
Bachelor’s or Master’s degree in Microbiology or equivalent
Minimum 6 years microbiology or quality/regulatory experience
Experience interacting with regulatory agencies (FDA, MoH, TUV)
High proficiency in statistical techniques and data analysis