Principal Specialist, Quality Assurance - Microbiology
Core
Principal Specialist ensuring cGMP compliance and product safety in PET facilities and Microbiology labs through documentation management, investigation leadership, and method validation.
Role type
Senior IC Quality Assurance Specialist (Microbiology)
Builds
Compliant quality systems, investigation reports, and validated microbiological methods for PET manufacturing
Domain
Pharmaceutical/Medical Device Manufacturing (cGMP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, root cause analysis, deviation/CAPA management, microbiology method validation, environmental monitoring trend analysis, technical writing, data integrity (ALCOA+), cross-functional collaboration
Preferred skills
Microbiology identification, Veeva/eBR system proficiency, SAP usage, mentorship
Technologies
Veeva, eBR, SAP, Microsoft Office
Responsibilities
Author and manage deviations, CAPAs, and SOPs; Lead OOS investigations and root cause analysis; Review Environmental Monitoring (EM) trend analysis; Support audit readiness and inspection responses; Provide technical support for microbiological assessments and method validation; Collaborate with Manufacturing, Engineering, and Supply Chain teams
Seniority
Senior, hands-on IC with mentorship capabilities
