Analyst II, QC Microbiology
Top Benefits
About the role
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. Job Responsibilities Testing & Monitoring 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. Write and execute method suitability protocols and reports, 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 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. Complete Organism Risk assessments for organisms identified from in-process, water, and raw material samples. Quality Systems & Documentation Act as Lead Investigator/Author on assigned Out of Specification, Laboratory, Environmental Monitoring, and Deviation investigations. Drive Change Control development and closure, and lead CAPA development and implementation for assigned investigations. Author and revise SOPs and Test Methods as assigned. Employ good documentation practices when generating raw data, reports, SOPs, and other documentation. Report deviations from procedures or other discrepancies affecting quality or cGMP compliance to Supervisor/Manager. Mentor and train Analyst (H-L3) QC Microbiologists on laboratory techniques, GMP practices, and investigation procedures. Training & Development Support validation media fill training sessions and 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. Minimum Qualifications Solid working knowledge of microbiology test methodologies. Working knowledge of aseptic technique and clean room behaviour. Knowledge of cGMPs and compendial test requirements. 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. Preferred Qualifications Bachelor's degree in Microbiology, Life Sciences, or a related scientific discipline; or a Microbiology college diploma/certification combined with equivalent relevant experience 2+ years of relevant experience in a GMP-regulated biopharmaceutical or pharmaceutical laboratory environment. Experience with industry-specific computerized applications (e.g., Veeva, Novatek, SAP). Prior aseptic operations experience. Knowledge of US and international GMPs including Health Canada, FDA, and EMA/EU Annex 1 requirements and compendial standards (USP, EP). Physical & Work Environment 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 10 lbs related to environmental monitoring, and working in cleanroom environments with appropriate gowning requirements. 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. Join Our Talent Community Don't see a posting that's the right fit? Join our talent community to be considered in our talent pool and we'll reach out if the right opportunity arises. RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives. Please Note – Resilience does not accept unsolicited agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience. Culture Focus Sites
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Analyst II, QC Microbiology
Top Benefits
About the role
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. Job Responsibilities Testing & Monitoring 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. Write and execute method suitability protocols and reports, 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 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. Complete Organism Risk assessments for organisms identified from in-process, water, and raw material samples. Quality Systems & Documentation Act as Lead Investigator/Author on assigned Out of Specification, Laboratory, Environmental Monitoring, and Deviation investigations. Drive Change Control development and closure, and lead CAPA development and implementation for assigned investigations. Author and revise SOPs and Test Methods as assigned. Employ good documentation practices when generating raw data, reports, SOPs, and other documentation. Report deviations from procedures or other discrepancies affecting quality or cGMP compliance to Supervisor/Manager. Mentor and train Analyst (H-L3) QC Microbiologists on laboratory techniques, GMP practices, and investigation procedures. Training & Development Support validation media fill training sessions and 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. Minimum Qualifications Solid working knowledge of microbiology test methodologies. Working knowledge of aseptic technique and clean room behaviour. Knowledge of cGMPs and compendial test requirements. 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. Preferred Qualifications Bachelor's degree in Microbiology, Life Sciences, or a related scientific discipline; or a Microbiology college diploma/certification combined with equivalent relevant experience 2+ years of relevant experience in a GMP-regulated biopharmaceutical or pharmaceutical laboratory environment. Experience with industry-specific computerized applications (e.g., Veeva, Novatek, SAP). Prior aseptic operations experience. Knowledge of US and international GMPs including Health Canada, FDA, and EMA/EU Annex 1 requirements and compendial standards (USP, EP). Physical & Work Environment 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 10 lbs related to environmental monitoring, and working in cleanroom environments with appropriate gowning requirements. 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. Join Our Talent Community Don't see a posting that's the right fit? Join our talent community to be considered in our talent pool and we'll reach out if the right opportunity arises. RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives. Please Note – Resilience does not accept unsolicited agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience. Culture Focus Sites