QC Analyst

7 days ago

Toronto, Canada Apex Systems Full time

QC Analyst Client: Biotechnology company Contract/Perm & duration: 12-month contract (possibility of extension/conversion) Location: Toronto Rate: $25-30/hr Responsibilities: Perform and/or support QC testing activities for samples generated for release testing and compliance of cell therapies destined for human clinical trials, as well as materials used in their production. Support process implementation for sample receipt, and in-process and release testing of raw materials, cell lines, process intermediates, drug products and other materials. Liaise with CROs for sample submissions and external testing results reporting. Support testing execution as required for transfer of QC test methods, characterization assays and/or qualification of methods. Write, review and drive approval of SOPs related to quality control testing including test methods, and equipment operation and maintenance procedures. Support Quality Assurance (QA) documentation functions for cGMP production, in-process testing and release testing of cell therapies. Support QA and QC functions for laboratory operations, including equipment maintenance, review and tracking of samples, testing results, materials inventory and reagent preparation. Support QA and QC functions for cleanroom operations, including review and tracking of Environmental Monitoring data and cleanroom maintenance practices. Other duties as required. Minimum Requirements: BSc or MSc in Life Sciences, Cell Biology, Genetics, Biotechnology, Biochemistry or related field. Docusign Envelope Preference for experience in Quality Control and experience with Good Documentation Practices and working in a cGMP or equivalent environment. Experience in one or more of the following techniques is required: Flow cytometry, PCR, Pluripotent Stem cell culture, Fluorescence microscopy, High throughput imaging, Next generation sequencing, ELISA, HPLC. Experience with liquid handling robots highly preferred Experience in the following areas is highly desirable: cell therapy, pluripotent stem cells, gene editing, biotech. 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 fast-paced, collaborative environment with a team-oriented focus. Occasional weekend work on an as needed basis may be required.

  • QC Analyst

    7 days ago

    toronto, Canada Apex Systems Full time

    QC Analyst Client: Biotechnology companyContract/Perm & duration: 12-month contract (possibility of extension/conversion)Location: TorontoRate: $25–30/hrResponsibilities:· Perform and/or support QC testing activities for samples generated for release testing and compliance of cell therapies destined for human clinical trials, as well as materials used in...

  • QC Analyst

    7 days ago

    Toronto, Canada Apex Systems Full time

    QC Analyst Client: Biotechnology companyContract/Perm & duration: 12-month contract (possibility of extension/conversion)Location: TorontoRate: $25–30/hrResponsibilities:· Perform and/or support QC testing activities for samples generated for release testing and compliance of cell therapies destined for human clinical trials, as well as materials used in...

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