QC Microbiology Technical Specialist 

Eurofins PSS is seeking a QC Microbiology Technical Specialist to serve as the primary technical resource for microbiological quality control activities within a GMP-regulated pharmaceutical environment. This role is embedded at a client site and requires a highly experienced professional capable of independently executing complex microbiological assays, supporting compliance initiatives, and serving as the go-to expert for microbiology-related inquiries. While not a formal leadership role, this position offers potential for future advancement into leadership based on performance and business needs.Core Competencies & Technical Expertise:Sterility and Endotoxin Testing (including BacT rapid sterility assay)USP <71>, <85>, <61>, <62> standardsGrowth Promotion Testing, Gram Staining, Sub-culturingEnvironmental Monitoring (viable/non-viable) in GMP cleanroom environmentsAseptic Process Simulation (Media Fills)cGMP, GDP, and ALCOA principlesMammalian Cell Culture and Aseptic ProcessingPrimary Responsibilities:Perform sterility, endotoxin, pH, and osmolality testing on raw materials, intermediates, and finished drug products.Conduct microbiological assays including gram staining, growth promotion, isolate sub-culturing, and cell culture maintenance.Coordinate and execute testing schedules aligned with manufacturing operations.Lead execution and support of aseptic process simulations (media fills), including associated visual inspections.Maintain laboratory compliance through equipment calibration, housekeeping, and accurate documentation.Author and revise SOPs, change controls, and qualification protocols for microbiological methods.Investigate Out-of-Specification (OOS) results and author comprehensive investigation reports; implement CAPAs as needed.Ensure data integrity and compliance with ALCOA and GDP standards across all documentation and systems.Conduct internal audits and GEMBA walk-throughs to ensure regulatory compliance.Collaborate with cross-functional departments (Manufacturing, QA, Facilities) to support operational goals.Perform environmental monitoring (air, surface, personnel, particulate) within aseptic manufacturing areas.Provide oversight during critical aseptic manufacturing steps to ensure procedural accuracy.Train and mentor junior staff and support onboarding of new laboratory personnel.