Sr. Associate II, Quality Control Lab - Microbiology
Core
Lead advanced projects in Quality Control Lab focusing on environmental monitoring, testing, and maintaining aseptic practices for sterile manufacturing.
Role type
Senior IC microbiologist (GMP/aseptic manufacturing)
Builds
Production-grade sterile medical devices and biologics
Domain
Medical devices / Biologics / Sterile manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology, aseptic processing, contamination control, environmental monitoring, root cause analysis, risk assessment, CAPA implementation, GMP compliance, data integrity, regulatory knowledge (FDA/EU GMP Annex 1/PIC/S), cleanroom behavior, microbiological investigations, mentorship
Preferred skills
None stated
Technologies
None stated
Responsibilities
Manage environmental monitoring and microbiological testing programs; Lead investigation of microbiological excursions and implement CAPAs; Review and approve microbiological test results, procedures, and protocols; Support validation, qualification, and routine microbiological assessments; Perform risk assessments related to microbiological control; Provide microbiological expertise and training to site personnel; Mentor junior microbiologists and laboratory staff; Ensure compliance with data integrity and GMP requirements; Support the site's Contamination Control Strategy (CCS)
Seniority
Senior, hands-on IC