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Job Details Client: Biotechnology company Contract/Perm & Duration: 12-month contract (possibility of extension/conversion) Location: Toronto, Onsite Monday-Friday Pay Rate: $26-30/hr (T4) Job#: 3023323 Title: Analytical & Quality Control Specialist II - Environmental Monitoring / Microbiology Description of Position The Analytical & Quality Control (A&QC) Specialist II - Environmental Monitoring (EM) / Microbiology will perform various EMrelated activities according to internal SOPs and policies that provide regulatory compliance and maintain control around the quality of product manufacturing. In addition to the EM program, the specialist will assist and perform microbiological testing of cell therapeutics for preclinical studies and human clinical trials. The specialist will help with technical and administrative support related to GMP cleanroom environmental monitoring and documentation, design and maintain an EM program for GMP compliance, support effective collaboration and liaise with the GMP Manufacturing team to ensure EM support is provided. Duties also include routine laboratory maintenance, equipment checks and maintenance, reagent preparation and analytical testing support as required. Responsibilities Perform EM sampling in a cleanroom setting and testing in accordance with internal policy and SOPs and ensure the use of proper aseptic technique during execution. Knowledgeable with EM lab equipment and techniques (SAS, Climet Particle Counter, viable airborne monitoring (active and passive), viable surface monitoring, and personnel monitoring) and regulatory guidance pertaining to EM. Perform EM plate incubations and plate enumeration to attain final viable EM results. Execute microbiology testing in the A&QC laboratory (Endotoxin and Sterility (BaCT/Alert)), including instrument and equipment, support drafting and revising SOPs. Liaise with external CROs used to perform microbial identification. Review data for accuracy and compliance with specifications, reporting errors to supervisor. Maintain microbiological EM database and prepare trending reports. Perform training of aseptic gowning to fellow employees and perform gowning qualifications in controlled classified cleanroom areas. Train team members to ensure competency in assigned laboratory activities. Assist with internal investigations, deviations or event reports and ensure the closure of such reports for nonconforming results in a timely manner. Occasional weekend work on an asneeded basis. Perform other general duties as required. Minimum Requirements BSc in Life Sciences with minimum 3 years (Bachelors) relevant experience in Microbiology, Cell Biology, Genetics, Biotechnology, or related field. Minimum 2 years of wetlab experience, displays a good understanding of and proficiency in EM, cleanroom control strategy, aseptic techniques and other pharmaceutical microbiology lab activities. Experience in one or more of the following areas is preferred: Microbiology/EM, Endotoxin, Sterility (BaCT/Alert), Mycoplasma (BioFire), pH and Osmolality, aseptic process and mediafill qualification and LIMS. Strong preference for experience in Quality Control and experience with Good Documentation Practices and working in a cGMP or equivalent environment. Excellent written and oral communication skills, with keen attention to detail and highly organized. Demonstrated flexibility in adjusting to changing priorities and schedules. Ability to work independently in a fastpaced, collaborative environment with a teamoriented focus. Occasional weekend work on an asneeded basis may be required. Equal Opportunity Employment Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Benefits Department at (emailprotected) or 8045238228. (Do not submit resumes or solicit consultants to this email address). UnitedHealthcare creates and publishes the Transparency in Coverage MachineReadable Files on behalf of Apex Systems. #J-18808-Ljbffr