Overview
Analyst, QC Microbiologist (Fixed – Term Contract) Jobs in Mississauga, Ontario at BioSpace
Title: Analyst, QC Microbiologist (Fixed – Term Contract)
Company: BioSpace
Location: Mississauga, Ontario
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.
For more information, please visit www.resilience.com
Major ResponsibilitiesLABORATORY
Receive test samples
Prepare reagents, standards, controls, and samples for analysis
Follow established procedures for the receipt, use and management of inventory of reagents, test media and supplies
Perform microbial tests including LAL, Bioburden, Microbial Identification, BI testing, and Growth Promotion Testing
Perform method suitability testing (including all supporting documentation)
Perform scheduled cleaning and other laboratory housekeeping duties as assigned
Performs all other job-related duties as assigned
This position is a fixed-term contract position for the next 18 months.
2nd shift position Monday – Friday with the flexibility to work weekends when needed
ENVIRONMENTAL MONITORING
Perform routine sampling of all qualified areas (including personnel) to ensure that all sampling frequencies are met as per current procedures.
Perform environmental monitoring of new areas to support room performance qualification.
Perform water sampling of manufacturing plan that could involve heights over (3) meters
Perform monthly Compressed Air sampling of manufacturing plant
Perform spot checks of manufacturing personnel during filling operations to ensure strict adherence to aseptic technique/processing procedures
Support the creation and assessment of trending reports (EM and Utilities systems)
Performs all other job-related duties as assigned
QC MICROBIOLOGY GENERAL SUPPORT
Employ good documentation practices when generating raw data, reports, SOPs and other documentation
Follow established procedures for use of released media that has a valid expiry date.
Collect, Analyze, interpret, and report data
Verify data including peer review of data where required
Quality Systems
Participate in investigations (e.g. Out of Specification investigations, Laboratory investigations, Environmental Monitoring Investigations and Deviation investigations); may require acting as Lead Investigator/Author
Support Change Control Process (initiate, implement and close as needed)
Support CAPA program (support and implement both immediate and long-term corrective actions)
Review SOPs and Test Methods, propose required updates and process updates when required
Check and follow up with materials, inventory and equipment calibrations/maintenance when required
Attend validation media fill training sessions to prepare for protocol execution
Maintain gown qualification status to perform EM in clean rooms
Must be able to stand for 50% of the shift and lift equipment (up to 10lbs) related to Environmental Monitoring
Request equipment calibration/maintenance quote when required and send equipment for calibration/maintenance on time
Report to supervisor/manager any deviation from procedures or other discrepancy that may affect quality or cGMP
Provide training to other Associate, QC Microbiologists when requested
Report Health and Safety incidents, accidents, or potential hazards
Performs all other job-related duties as assigned
Minimum Qualifications
…
