Analyst Ii, Qc Microbiology

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.

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MAJOR RESPONSIBILITIES:
LABORATORY
- 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:

- Basic understanding of microbiology test methodologies
- Basic understanding of aseptic technique
- Knowledge and understanding of GMP, compendial test requirements
- Basic understanding of data analysis, statistics, and report preparation with knowledge of MS Word and Excel
- Must have the ability to work independently, multi-task, be self-motivated, highly organized, and able to work in a fast
- paced quality control environment
- Strong attention to detail in job execution and data completion and review

PREFERRED QUALIFICATIONS:

- Bachelor’s degree in Life Science or Microbiology college diploma/certification
- Aseptic Operations experience and understanding of aseptic operations controls
- Knowledge and understanding of Canadian & US GMPs and European Pharmacopoeia requirements

Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.