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QC Specialist

Apex Systems

This is a Contract position in Burnaby, ia posted September 12, 2021.

QC Specialist 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 cGMP documentation, Flowcytometry, and PCR and for one of our biotech clients in Toronto.

Client: Biotechnology company Contract/Perm & duration: 3-month contract (extension likely) Location: Toronto This position will be working 80% on-site as lab work is required.

Responsibilities Work with project teams to establish Phase appropriate cGMP standards for testing Cell-based Materials to support cell therapy programs.

Implement and perform QC release testing activities for samples, stem cells, reagents and other materials for use in GMP drug substance production.

Liaise with CROs for sample submissions and external testing results reporting.

Support development of QC test methods, primarily cell-, genetic
– and protein-based methods.

Liaise with project teams to perform test transfer for QC test methods and cell-based characterization assays.

Support studies to qualify QC test methods as required.

Write SOPs related to quality control testing including test methods, and equipment operation, maintenance, and calibration 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 review and tracking of inventory.

Other duties as required Minimum Requirements BSc in Life Sciences, Genetics, Cell Biology, Biotechnology, or related field 2 years of relevant experience, strong preference for experience in Quality Control Experience working in a cGMP or equivalent environment Working knowledge in the following areas is highly desirable: cell therapy, gene editing, stem cells, protein characterization, molecular biology Experience in the following techniques is an asset: Flow cytometry, ELISA, PCR, Microscopy, Stem cell culture 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, team-oriented organization Occasional weekend work on an as needed basis will be required