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JOB DESCRIPTION

POSITION: Microbiologist

COMPANY AND LOCATION: Stratum Analytical, Oshawa, ON

EMPLOYMENT TYPE: Permanent, full time

HOURS WORKED: 37.5 hours/week

DIRECT REPORTS: No

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POSITION SUMMARY:

The Microbiologist is responsible for conducting microbiological testing, analysis, and research to ensure product quality, safety, and regulatory compliance. This role involves performing a range of microbiological tests, including sterility, environmental monitoring, and microbial identification, as well as overseeing an equipment maintenance program to ensure all laboratory instruments are calibrated, maintained, and functioning optimally. The Microbiologist collaborates with quality assurance, laboratory, and production teams to troubleshoot, document, and resolve microbiological issues. In addition, this role requires maintaining laboratory compliance, staying current with regulatory standards, to ensure that all quality systems and processes meet the regulatory requirements set forth by Health Canada and comply with ISO 9001 standards.

GENERAL RESPONSIBILITIES & ESSENTIAL FUNCTIONS

Analytical Testing

Perform routine testing on samples efficiently and independently; accurately record results, ensuring all assigned testing deadlines are met.

Document, report, and promptly investigate any unexpected test results.

Conduct maintenance, calibration, and troubleshooting of assigned equipment and systems to ensure operational readiness; notify the manager of any calibration issues or repair needs.

Execute complex testing procedures, including but not limited to Sterility Testing, Antimicrobial Effectiveness Testing, Microbial Enumeration, Endotoxin testing and Microbial Identification.

Provide technical support and cross-functional assistance across laboratory workstations as needed.

Stay informed on industry advancements and trends.

Track and analyze environmental monitoring data; address any alert or action level exceedances immediately.

Method Implementation and Process Improvement

Lead the implementation and validation of new microbiological methods, instruments, and workflows to enhance laboratory capability.

Contribute to the development of new laboratory methods in response to client and market requirements.

Evaluate and optimize existing testing procedures to improve accuracy, efficiency, and turnaround time.

Collaborate with Quality Assurance to ensure new processes meet regulatory and ISO 17025/9001 compliance requirements.

Develop and maintain Standard Operating Procedures (SOPs), method validation reports, and related documentation.

Train and mentor laboratory staff on new techniques and best practices for method adoption and process optimization.

Participate in continuous improvement initiatives, identifying opportunities to streamline operations and support laboratory growth.

Quality Processes

Participate in the implementation, review, and improvement of the QMS.

Collaborate with the quality assurance department on the resolution of quality incidents, including Out of Specification (OOS) results and deviations, by conducting initial investigations and preparing formal deviation reports.

Evaluate quality processes against regulatory standards and requirements.

Determine impact, identify root causes, and develop Corrective and Preventive Actions (CAPAs) to maintain compliance.

Contribute to Change Control creation and review processes.

Support internal, site, and vendor audits.

Microbiology Equipment Maintenance Program Lead

Oversee the microbiology equipment maintenance program, ensuring all laboratory instruments and equipment are maintained according to schedule and meet operational standards.

Develop, implement, and review maintenance protocols for microbiology-specific equipment, including routine calibration, performance verification, and preventative maintenance.

Coordinate with internal teams and external vendors to plan and conduct regular equipment calibrations, repairs, and qualifications (e.g., IQ/OQ/PQ) to maintain compliance with regulatory standards.

Maintain up-to-date records of maintenance activities, calibration certificates, and equipment repair logs; promptly address and document any deviations or equipment issues.

Conduct root cause analyses for equipment malfunctions, identifying corrective actions and collaborating on preventive strategies to reduce downtime and ensure optimal functionality.

Train laboratory personnel on the proper use, maintenance, and troubleshooting of microbiology equipment, reinforcing adherence to standard operating procedures and safety protocols.

Regularly review and update maintenance SOPs to ensure they reflect best practices and comply with industry standards and regulatory requirements.

Support continuous improvement initiatives by identifying opportunities to enhance equipment reliability and reduce operational costs through efficient maintenance practices.

Compliance Management

Adhere to company policies and all applicable Standard Operating Procedures (SOPs).

Maintain compliance with ISO 17025, cGMP, cGLP, A2LA, Canadian Biosafety Standards, Health Canada’s Human Pathogens Act and Regulations, PHAC Pathogen Licence, WHMIS, and Quality Control Guidelines.

Ensure all SOPs are accurate, current, and aligned with regulatory standards.

Participate in cross-technology training programs to acquire a comprehensive understanding of all laboratory functions.

Stay updated on laboratory equipment, systems, procedures, and industry standards, with an emphasis on microorganism handling, equipment troubleshooting, and microbiology taxonomy.

Accurately document and maintain laboratory records.

Write, revise, and review SOPs as required to support laboratory functions.

Assist with laboratory and safety audits to ensure a compliant and safe work environment.

Maintain a clean, organized, and safe laboratory area and contribute to safety training programs.

Support validation activities and projects.

Accurately monitor, identify, and report microbiological trends.

Conduct technical reviews of adverse trends, action limit reports, and any discrepancies.

Provide training to new and current microbiology staff as needed.

Order and maintain accurate records of microbiology inventory.

Assist with special projects as assigned.

QUALIFICATIONS

Relevant experience in quality assurance and quality control within an analytical laboratory environment.

Proficiency with QMS software.

Strong knowledge of ISO 9001 standards and quality management principles.

Familiarity with Health Canada and GMP regulations.

Hands-on experience in a microbiology laboratory (Containment Level 2 experience is beneficial).

Experience with RG2 pathogen growth and maintenance.

Demonstrates proficiency in a variety of microbiological methods, including USP-compliant testing for microbial enumeration, sterility, endotoxin detection, and antimicrobial effectiveness.

Strong analytical, decision-making, and interpersonal skills.

Excellent verbal and written communication skills.

In-depth understanding of microbiology principles (e.g., aseptic techniques) and methods, with the ability to train others.

Ability to troubleshoot and resolve both routine and complex laboratory issues.

Physical dexterity and precision in testing.

Ability to read, understand, and comply with company policies and SOPs, including all safety regulations.

Intermediate proficiency in Microsoft Office (Word, Excel, Outlook, and PowerPoint).

EDUCATION

Master’s or Bachelor’s degree in Microbiology, Biotechnology, or a related field, including at least 12 semester hours of hands-on laboratory coursework in microbiology and/or chemistry.

Minimum of 5 years of experience in a pharmaceutical or biochemical QC laboratory setting specializing in microbiology with a Bachelor’s degree.

SPECIFIC WORKING CONDITIONS OR PHYSICAL REQUIREMENTS

Ability to lift and carry laboratory equipment, reagents, and samples.

Fine motor skills and manual dexterity for tasks such as pipetting, handling small samples, and operating lab equipment.

Comfortable wearing appropriate PPE, including lab coats, gloves, safety glasses, and respirators when necessary.

Adherence to safety protocols and proper handling of chemicals.

Working with biohazardous materials and hazardous chemicals.

Working in an ISO 5 Isolator and Biological Safety Cabinet.

OUR RECRUITMENT PROCESS:

Application and Questionnaire - Candidates submit an application and complete the initial questionnaire.
Pre-Screen Video Interview - Qualified candidates will be invited within one week to complete a short one-way video pre-screen.
In-Person Interview - Shortlisted candidates will be invited to attend an in-person interview at our head office.
Offer and Background Check - The successful candidate will be offered the position, pending a criminal background check and references.

We appreciate the applications from all candidates, but only those selected for the next steps will be contacted.

Stratum Analytical is an equal opportunity employer. We welcome diversity and are committed to creating an inclusive environment for all employees. Accommodations are available on request for candidates taking part in all aspects of the selection process.

*This position is being posted to fill an existing vacancy within our team.

Auxilium Health

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Microbiologist