Analyst II, QC Microbiology

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. 

• 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