Job Title

QC Specialist I (BioTech) Apex Systems is a large staffing and consulting firm and we are looking for a QC Specialist with experience in quality divisions of biotechnology firms with knowledge of aseptic techniques, Microbiology (i.e. cell culture, bacterial streaking), and cGMP documentation, for one of our biotech clients in Toronto. Client: Biotechnology company Contract/Perm & duration: 12-month contract (possibility of extension/conversion) Location: Toronto This position will be working 80%+ on-site as lab work is required. The Quality Control (QC) Specialist I- Environmental Monitoring (EM), will perform various EM-related activities according to internal SOPs and policies that serve to provide regulatory compliance and maintain control around the quality of product manufacturing. In addition to EM, the specialist will assist the QC team in the day-to-day laboratory operations and duties to support testing of cell therapeutics for pre-clinical studies and human clinical trials. Duties will include routine laboratory maintenance, equipment checks and maintenance, lab inventory management support, reagent preparation and analytical testing support as required. Responsibilities: Perform EM in accordance with internal policy and SOPs and ensure the use of proper aseptic technique during execution. Be knowledgeable on EM lab equipment and techniques (SAS, Clinet Particle Counter, viable airborne monitoring (active and passive), viable surface monitoring, and personnel monitoring) and become familiar with regulatory guidance pertaining to EM. Perform EM plate incubations and perform plate enumeration to attain final viable EM results. Review data for accuracy and compliance to specifications, reporting errors to supervisor. Liaise with external CROs used to perform microbial identification. Update microbiological EM database and prepare reports as requested. Perform maintenance of EM database and trend data. Perform training and of aseptic gowning to fellow employees and perform gowning qualifications. Assist with EM excursions and investigations. Maintains laboratory supplies, media, and reagents inventory. Assist the QC team with execution of test methods and SOPs as required, including instrument preparation and equipment pre-checks. Aid in drafting and revising SOPs as needed. Support the setup and maintenance of the laboratory in an organized and compliant manner, including executing appropriate laboratory cleaning activities. Occasional weekend work on an as needed basis. Perform other general duties as required. Key Qualifications: Diploma in Biotechnology, Biology, Microbiology or related field. Minimum 2 years of wet-lab experience. Excellent written and oral communication skills Keen attention to detail and highly organized. Experience working in a cGMP environment is a plus. Experience in one of the following areas is preferred: microbiology, environmental monitoring, clean room control strategy and QC testing. Demonstrate flexibility in adjusting to changing priorities and schedules. Ability to work independently in a fast-paced, collaborative environment with a team-oriented focus. Occasional weekend work on an as needed basis may be required. Ability to work independently in a fast-paced, team-oriented organization.