QC Analyst

5 days ago

Toronto, Ontario, 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.

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