Analyst, Qc Microbiology

COMPANY SUMMARY:

- RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We’re building a robust, dynamic, and diverse network of manufacturing capability and talent -investing in innovation every step of the way. We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines, as well as proteins and the next generation of medicines. RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small. We continuously invest in R&D for next generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives. We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that’s faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.
- ROLE:

- This job tests raw materials, utilities, in-process materials, final product, cleaning samples and biological indicators for microbial attributes according to, compendia cGMP and material/product specifications. This job will also read plates and record results and perform microbial identification activities.
- JOB RESPONSIBILITIES
- _:_
- Employ good documentation practices when generating raw data, reports, SOPs, and other documentation
- Receive test samples
- Verify data, including peer review of data
- Review SOPs and Test Methods and process updates
- Prepare reagents, standards, controls, and samples for analysis
- Follow established procedures for the receipt, use and management of inventory of reagents, test media and supplies
- Perform microbial tests including LAL, Bioburden, Microbial Identification, BI testing, and Growth Promotion Testing
- Collect, Analyze, interpret, and report data
- Provide data for the preparation of quarterly trending reports
- Perform scheduled cleaning and other laboratory housekeeping duties as assigned
- Implement both immediate and long-term Corrective Actions
- Participate in Out of Specification investigations
- Report to supervisor/manager any deviation from procedures or other discrepancy that may affect quality or cGMP
- Provide training to other Associate, QC Microbiologists when requested
- Perform Environmental Monitoring as a backup
- Report Health and Safety incidents, accidents, or potential hazards
- Performs all other job-related duties as assigned
- PREFERRED QUALIFICATIONS:
- Knowledge and understanding of GMP, compendial test requirements, US and European Pharmacopeia
- MINIMUM QUALIFICATIONS:
- Bachelor’s degree in Life Science or Microbiology college diploma/certification
- Basic understanding of microbiology test methodologies
- Knowledge and understanding of GMP, compendial test requirements
- Basic understanding of data analysis, statistics, and report preparation with knowledge of MS Word and Excel
- Must have the ability to work independently, multi-task, be self-motivated, highly organized, and able to work in a fast
- paced quality control environment
- Strong attention to detail in job execution and data completion and review
- ADDITIONAL REQUIREMENTS:
- Pre-employment medical and medical re-examination; inclusive of eye examination and colour blindness test, performed every 2 years or as per Resilience’s SOPs
- This position requires vaccination for Hepatitis A and B
- Job requires shift work, weekends, and occasional extended shifts and possible short notice schedule shifts
- BEHAVIOURAL:

Problem Solving: Anticipating, analyzing, diagnosing and resolving problems.
- Goal Orientation: Energetically focusing efforts on meeting a goal, mission, or objective.
- Written Communication: Writing clearly, succinctly, and understandably.
- Decision Making: Utilizing effective process to make decisions.
- Organization and Planning: Utilizing logical, systematic, and orderly procedures to meet objectives.
- Flexibility: Agility in adapting to change. Ability to work independently
- Attention to Detail: Ensure work or reviews are correct and Right First Time.- 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.