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 II, QC Microbiology reports to the QC Supervisor, supporting QC Microbiology operations. This position requires working in Controlled/Non-Classified and Classified areas. The Analyst II independently performs microbiology testing and environmental monitoring, leads assigned investigations, and provides guidance and mentoring to Analyst team members.
Independently perform microbial tests including LAL/Endotoxin, Bioburden, Sterility, Microbial Identification, Biological Indicator testing, and Growth Promotion Testing.
Prepare reagents, standards, controls, and samples for analysis; manage inventory of reagents, test media, and supplies; and oversee equipment calibration and maintenance for assigned areas.
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 lead the creation and assessment of environmental monitoring and utilities trending reports, identifying and escalating adverse trends.
Collect, analyze, interpret, and report data; perform advanced data review, and review and approve Novatek data entries.
Quality Systems & Documentation
Act as Lead Investigator/Author on assigned Out of Specification, Laboratory, Environmental Monitoring, and Deviation investigations.
Employ good documentation practices when generating raw data, reports, SOPs, and other documentation.
Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language.
Knowledge of US and international GMPs including Health Canada, FDA, and EMA/EU Annex 1 requirements and compendial standards (USP, EP).
Physical & Work Environment
Physical demands may include standing for extended periods, ability to lift up to 10 lbs related to environmental monitoring, and working in cleanroom environments with appropriate gowning requirements.
Pre-employment medical and medical re-examination: inclusive of eye examinations and color blindness tests, performed every 2 years or as per RESILIENCE's SOPs.
This position requires vaccination for Hepatitis A and B
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 $60,000.00 - $82,500.00 per year. 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.
