Quality Control Microbiology Specialist
Core
Technical resource and SME for QC Microbiology lab operations, performing assays for clean room, utility, raw material, and product testing per cGMP/FDA regulations.
Role type
Senior IC Quality Control Microbiology Specialist
Builds
Microbiological testing programs and quality system compliance
Domain
Pharmaceutical manufacturing / Microbiology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Microbiological testing methods, cGMP compliance, root cause analysis, Change Control/CAPA, data integrity, SOP authoring, trend analysis, LIMS proficiency
Preferred skills
Biologics/sterile manufacturing experience, regulatory inspection support, new method implementation, cross-functional project leadership
Technologies
LIMS, LMS, electronic quality management systems, Microsoft Office
Responsibilities
Evaluate and implement new microbiological methods and procedures; lead laboratory investigations and root cause analyses; author and review SOPs and technical reports; monitor regulatory updates and incorporate changes; facilitate inspection readiness and participate in audits; analyze lab performance metrics and KPIs; support continuous improvement initiatives.
Seniority
Mid-level, hands-on IC