Overview
Analyst II, QC Microbiology Jobs in Mississauga, Canada at National Resilience
A career at Resilience is more than just a job – it’s an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
The AnalystII, QC Microbiology reports to the QC Supervisor, supporting QC Microbiology operations. This position requires working in Controlled/Non-Classified and Classified areas. The Analyst II independently performs microbiology testing and environmental monitoring, leads assigned investigations, and provides guidance and mentoring to Analyst team members.
Job Responsibilities
Testing & Monitoring
Independently perform microbial tests including LAL/Endotoxin, Bioburden, Sterility, Microbial Identification, Biological Indicator testing, and Growth Promotion Testing.
Prepare reagents, standards, controls, and samples for analysis; manage inventory of reagents, test media, and supplies; andoverseeequipment calibration and maintenancefor assigned areas.
Write and executemethodsuitability protocols and reports, including all supporting documentation, following established procedures — including use of released media within its valid expiry date.
Perform environmental monitoring of classified and non-classified areas (viableair sampling, total airborne particle testing, surface sampling, and monthly compressed air sampling), and water sampling of the manufacturing plant, which may involve working at heights over three (3) meters.
Perform gown monitoring of manufacturing personnel during filling operations to verify adherence to aseptictechnique, andlead the creation and assessment of environmental monitoring and utilities trending reports,identifyingand escalating adverse trends.
Collect, analyze, interpret, and report data; perform advanced data review, and review and approve Novatek data entries.
Complete Organism Risk assessments for organismsidentifiedfrom in-process, water, and raw material samples.
Quality Systems & Documentation
Act as Lead Investigator/Author on assigned Out of Specification, Laboratory, Environmental Monitoring, and Deviation investigations.
Drive Change Control development andclosure, andlead CAPA development and implementation for assigned investigations.
Author and revise SOPs and Test Methods as assigned.
Employ good documentation practices when generating raw data, reports, SOPs, and other documentation.
Report deviations from procedures or other discrepancies affecting quality or cGMP compliance to Supervisor/Manager.
Mentor and train Analyst (H-L3) QC Microbiologists on laboratory techniques, GMP practices, and investigation procedures.
Training & Development
Support validation media fill training sessions and protocol execution.
Acquireandmaintainall required certifications and qualifications for the assigned work area, including gownqualificationto perform environmental monitoring in clean rooms.
Minimum Qualifications
Solid working knowledgeof microbiology test methodologies.
Working knowledgeof aseptictechniqueand clean roombehaviour.
Knowledge ofcGMPsand compendial test requirements.
Proficiencyin data analysis and report preparation using MS Word and Excel.
Good attention to detail in job execution and data completion.
Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language.
Individualmust be capable of keeping accurate records and performing mathematical calculations.
Ability to work effectively in a team environment.
Preferred Qualifications
Bachelor’s degree in Microbiology, Life Sciences, or a related scientific discipline; or a Microbiology college diploma/certification combined with equivalent relevant experience
2+years of relevant experience in a GMP-regulated biopharmaceutical or pharmaceutical laboratory environment.
Experience with industry-specific computerized applications (e.g., Veeva, Novatek, SAP).
Prior aseptic operations experience.
Knowledge of US and international GMPs including Health Canada, FDA, and EMA/EU Annex 1 requirements and…
Title: Analyst II, QC Microbiology
Company: National Resilience
Location: Mississauga, Canada
Category:
