Qc Microbiologist - Mississauga, Canada - Resilience

Resilience

Verified Company

Mississauga, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

COMPANY SUMMARY:
RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing.

We're building a robust, dynamic, and diverse network of manufacturing capability and talent - investing in innovation every step of the way.

We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need.

This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines; as well as proteins and the next generation of medicines.

RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small.

We continuously invest in R&D for next generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.

We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities.

Through manufacturing that's faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.

JOB SUMMARY:

This job requires the incumbent to support QC Testing in the Microbiology Laboratory as well as support Environmental Monitoring (EM) on the Manufacturing shopfloor.

Within the QC Microbiology Laboratory, the Microbiologist will test raw materials, utilities, in-process materials, final product, cleaning samples and biological indicators for microbial attributes according to, compendia cGMP and material/product specifications.

This job will also read plates and record results and perform microbial identification activities.

Within the Manufacturing Facility, the Microbiologist will perform environmental monitoring to provide assurance that all areas continue to operate under a state of control.

This monitoring consists of non-viable particulate testing, viable air sampling, compressed air sampling and viable surface sampling.

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 jobrelated duties as assigned

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 jobrelated 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, Analyse, 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 longterm 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 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 jobrelated duties as assigned

MINIMUM QUALIFICATIONS: