QC Microbiology Analyst

Salary

Core Qualifications

Key Responsibilities

• •Execution of routine and ad-hoc clean utilities sampling as per the defined schedules (at rest and in operation)
• •Collection of viable Environmental Monitoring samples in GMP facilities (excl. restricted access areas) including, settle plates, touch plates, microbial air plates
• •Collection of viable and non-viable samples including but not limited to EM plates from GMP facilities, EM particle count samples, water, pure steam and compressed gas samples
• •Raw Materials sampling: Inspection of bulk raw materials delivered direct to site; LIMS and SAP data inputs; Liaison and scheduling with Shipping Coordinator and warehousing team
• •Logging samples in LIMS and labelling all samples according to GMP and client SOP requirements
• •Document collection of samples in data system forms/LIMS
• •Filing and archiving of physical sampling paper records
• •Download and back up raw data from sampling equipment as required
• •Conduct investigations into anomalies in sampling, testing, and results, applying scientific methodology to identify root causes and recommend corrective measures
• •Logging of internally and externally generated results in LIMS within required timeframes
• •Liase with PSS shipping team to book and prepare samples for dispatch to offsite testing laboratory (including LIMS labelling, bagging and paper records preparation)
• •Data entry checks of all data generated in an effort to apply a “Right First Time” approach in all areas
• •Analyse and interpret data arising from laboratory operations, contributing to the continuous improvement of scientific protocols and processes
• •Participate in deviations and investigations. Collaborate with cross-functional teams, contributing specialist life science expertise to support problem-solving in QC applications and sterile techniques
• •Attend TGA audits as sampling and testing SME as required
• •Documentation in Intelligent Batch Record System as required
• •Set up and manage incubation workflows. Prepare and load EM plates into designated incubators according to predefined environmental monitoring schedules. Ensure all incubators are correctly set, labelled, and monitored in accordance with SOPs and required environmental parameters
• •Perform incubation management and plate retrieval. Conduct routine checks of incubators, verify incubation conditions, and retrieve plates at the required time points. Document any deviations or anomalies observed during incubation
• •Test and interpret EM samples: Read EM plates following approved SOPs, accurately record colony counts, classify growth types, and assess results against alert, action, and trending limits. Escalate out-of-specification or atypical results in line with established procedures
• •Review plate results to determine which samples require further microbiological identification, ensuring decisions are aligned with SOP/MET criteria and regulatory expectations
• •Discard EM plates following completion of analysis in accordance with biosafety, GMP, and waste-handling procedures to maintain a clean and compliant laboratory environment
• •Accurately enter microbial identification sample details into the Laboratory Information Management System (LIMS), ensuring traceability, completeness, and compliance with data integrity principles (ALCOA+)
• •Prepare and store plates designated for microbial identification under appropriate conditions prior to shipment. Ensure correct packaging, documentation, and chain-of-custody are maintained for timely external laboratory processing
• •Participate in Aseptic Process Simulation (APS) media fill vial incubation and visual inspection checks
• •Maintaining the consumables store in a well stocked clean and safe state
• •Maintaining routine calibration schedule of QC laboratory equipment and perform preventative maintenance as per work orders assigned in SAP
• •Support the development of innovative laboratory practices through continuous improvement initiatives informed by scientific principles
• •Assisting in the maintaining and development of HS&E standards in the workplace. Responsible for reporting any safety incidents personal to Eurofins Team Leader within 24 hrs
• •Act in accordance with the client & Eurofins Codes of Ethics, and all other relevant policies and procedures, as updated from time to time
• •Other duties as required