Job#: 3014938 Job Description: 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. EEO Employer 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 Employee Services Department at [email protected] or 844-463-6178. Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico. Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide. Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico. Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide. Apex Systems is part of the Commercial Segment of ASGN Incorporated. NYSE: ASGN 4400 Cox Road Suite 200 Glen Allen, Virginia 23060 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 Employee Services Department at [email protected] (Do not submit resumes or solicit consultants to this email address). UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Apex Systems.