Analyst – QC Microbiology - Project Management, AM

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

The Analyst, QC Microbiologist reports to the QC Supervisor, supporting QC Microbiology operations. This position requires working in Controlled/Non-Classified and Classified areas. The QC Microbiologist performs microbiology testing, environmental monitoring, and batch record entries in accordance with cGMPs.

Job Responsibilities

Testing & Monitoring

• Perform microbial tests, including LAL/Endotoxin, Bioburden, Microbial Identification, Biological Indicator, and Growth Promotion testing, and read/record microbial plates and perform microbial identification activities.

• Prepare reagents, standards, controls, and samples for analysis; manage inventory of reagents, test media, and supplies; and follow up on equipment calibration and maintenance as required.

• Receive and log test samples and perform method suitability testing, 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 (viable air 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 aseptic technique, and support the creation and assessment of environmental monitoring and utilities trending reports.

Quality Systems & Documentation

• Collect, analyze, interpret, verify (including peer review where required), and report data.

• Participate in investigations (e.g., Out of Specification, Laboratory, Environmental Monitoring, and Deviation) and support the Change Control and CAPA programs, including implementation of corrective actions.

• Report deviations from procedures or other discrepancies affecting quality or cGMP compliance to Supervisor/Manager.

• Review SOPs and test methods and propose updates when identified, employing good documentation practices when generating raw data, reports, and other documentation.

Training & Development

• Attend validation media fill training sessions to prepare for protocol execution.

• Acquire and maintain all required certifications and qualifications for the assigned work area, including gown qualification to perform environmental monitoring in clean rooms.

• Basic understanding of microbiology test methodologies.

• Basic understanding of aseptic technique and clean room behaviour.

• Knowledge of cGMPs and compendial test requirements.

• Basic proficiency in 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.

• Individual must be capable of keeping accurate records and performing mathematical calculations.

• Ability to work effectively in a team environment.

• Bachelor's degree in Microbiology, Life Sciences, or a related scientific discipline.

• 2+ years of progressive QC Microbiology experience in a GMP-regulated biopharmaceutical or pharmaceutical environment.

• Experience with industry-specific computerized applications (e.g., Veeva, Novatek, SAP).

• Experience in aseptic operations experience and gowning qualification.

• Knowledge GMP Regulations including Health Canada, FDA, PMDA, and compendial standards (USP, EP).

• Work may involve extended hours, including evenings and weekends, depending on project deadlines and operational needs.

• Physical demands may include standing for extended periods, ability to lift up to 45 lbs, and working in cleanroom environments with appropriate gowning 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.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a RRSP/DPSP with a generous company match, a very competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, paid vacation, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and employee referral program. Our target base pay hiring range for this position is $24.00 - $33.00 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.