Quality Control Specialist Microbiology - EM
Core
Subject Matter Expert for environmental monitoring programs, cleaning validations, training, trend analysis, and development of microbiological strategies in a GMP-regulated environment.
Role type
Senior IC microbiology quality control specialist
Builds
Production of pharmaceuticals and medical devices
Domain
Dermatology / Biopharmaceuticals / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Environmental monitoring program management, microbiological trend analysis, training and qualification of personnel, risk analysis (CCS, FMEA), validation documentation, SOP development, deviation handling, change control (CC), GAP analysis, inspection support, cleaning validation principles, disinfection principles, renmedia management
Preferred skills
Experience with ISO13485, experience with cleaning validation, disinfection principles, and/or renmedia, experience with deviation handling, risk analysis, and quality investigations
Technologies
GMP, cGMP, Pharmacopoeia, ISO13485
Responsibilities
Manage environmental monitoring programs for production of pharmaceuticals and medical devices, Analyze and trend data from environmental monitoring of cleanrooms and clean media systems, Train and qualify personnel for work in cleanroom environments, Write, review, and update quality documents including risk analyses, validation documentation, SOPs, Act as expert for quality issues such as deviations, change control requests, and GAP analyses, Provide expert support during inspections and internal audits, Identify improvement areas and drive initiatives within microbiological control and cleanroom work
Seniority
Senior, hands-on IC
