Job Description
The QC Microbiology analyst's primary responsibility is to perform routine and ad-hoc QC critical utilities and environmental monitoring, sampling, and testing services in GMP environments, reporting results within required time frames in LIMS and the clients Quality Management Systems.
Duties
* Execute routine and ad‐hoc clean utilities sampling as per defined schedules (at rest and in operation).
* Collect viable Environmental Monitoring samples in GMP facilities (excluding restricted access areas) – settle plates, touch plates, microbial air plates.
* Collect viable and non‐viable samples – EM plates, EM particle count samples, water, pure steam, compressed gas.
* Sample raw materials: inspect bulk raw materials delivered directly to the site, enter LIMS and SAP data, liaise and schedule with Shipping Coordinator and warehousing team.
* Log samples in LIMS and label all samples according to GMP and client SOP requirements.
* Document sample collection in data system forms/LIMS.
* File and archive physical sampling paper records.
* Download and back up raw data from sampling equipment as required.
* Investigate anomalies in sampling, testing, and results, applying scientific methodology to identify root causes and recommend corrective actions.
* Enter internally and externally generated results in LIMS within required timeframes.
* Coordinate with the PSS shipping team to book and prepare samples for dispatch to off‐site testing laboratories (including LIMS labeling, bagging, and paper records).
* Perform data entry checks to ensure a "Right First Time" approach.
* Analyze and interpret data arising from laboratory operations, contributing to continuous improvement of scientific protocols and processes.
* Participate in deviations and investigations, collaborating with cross‐functional teams to support problem‐solving in QC applications and sterile techniques.
* Attend TGA audits as sampling and testing SME as required.
* Document in the Intelligent Batch Record System as required.
* Set up and manage incubation workflows: prepare and load EM plates into designated incubators according to predefined schedules; ensure incubators are correctly set, labeled, and monitored in accordance with SOPs.
* Perform incubation management and plate retrieval; conduct routine checks of incubators, verify conditions, and retrieve plates at required time points; document deviations or anomalies.
* Test and interpret EM samples: read EM plates following approved SOPs, accurately record colony counts, classify growth types, assess results against alert, action, and trending limits, and escalates out‐of‐specification results in line with procedures.
* Review plate results to determine which samples require further microbiological identification, ensuring decisions align with SOP/MET criteria and regulatory expectations.
* Discard EM plates following completion of analysis in accordance with biosafety, GMP, and waste‐handling procedures.
* Enter microbial identification sample details into LIMS, ensuring traceability, completeness, and compliance with ALCOA+ data integrity principles.
* Prepare and store plates for microbial identification under appropriate conditions prior to shipment; ensure correct packaging, documentation, and chain‐of‐custody for timely external lab processing.
* Participate in Aseptic Process Simulation (APS) media fill vial incubation and visual inspection checks.
* Maintain the consumables store in a well‐stocked, clean, and safe state.
* Maintain routine calibration schedules of QC laboratory equipment and perform preventative maintenance as per SAP work orders.
* Support the development of innovative laboratory practices through continuous improvement initiatives.
* Assist in maintaining and developing HS&E standards in the workplace; report safety incidents to Eurofins Team Leader within 24 hours.
* Act in accordance with the client & Eurofins Codes of Ethics and all relevant policies and procedures.
* Other duties as required.
Qualifications
* Diploma, degree, or equivalent in Microbiology or Laboratory Sciences.
* Minimum 1+ year in a similar role.
* Experience with GMP and aseptic techniques.
* Experience working in a cleanroom environment.
Preferred Skills and Success Profile
* Builds customer allegiance.
* Focus on growth.
* Job knowledge.
* Teamwork and collaboration.
* Interpersonal skills.
* Dependability.
* Safety‐first mindset.
* Personal development.
* Problem solving and decision making.
Additional Information
* Willing to operate flexibly and switch priorities at short notice.
* Team player, organized, accurate, with strong documentation skills.
* Demonstrate problem solving in delivering process and analytical understanding.
* Good understanding of requirements for working in a GMP environment.
* Occasional weekend and public holiday work required.
* Ability to quickly learn new processes.
Contract Details
This is a fixed‐term contract.
Eligibility
Open to candidates eligible to work in Australia/New Zealand, who already have work rights or an appropriate working visa.
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