Qc Specialist Jobs

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 PCR/Flowcytometry, Microbiology techniques (cell culture), and cGMP documentation, for one of our biotech clients in Toronto.

Client: Biotechnology company

Contract/Perm & duration: 6-month contract (possibility of extension/conversion)

Location: Toronto

This position will be working 80%+ on-site as lab work is required.

Responsibilities

• Support Quality Assurance (QA) documentation functions for cGMP production, in-process testing and release testing of cell therapies.
• Liaise with CROs for sample submissions and external testing results reporting.
• Support QA and QC functions for laboratory operations, including equipment maintenance, review and tracking of samples, testing results, materials inventory and reagent preparation.
• Support testing execution as required for transfer of QC test methods, characterization assays and/or qualification of methods.
• 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.
• Other duties as required.
• Support process implementation for sample receipt, and in-process and release testing of raw materials, cell lines, process intermediates, drug products and other materials.
• Support QA and QC functions for cleanroom operations, including reviewing and tracking Environmental Monitoring data and cleanroom maintenance practices.
• Write, review and drive approval of SOPs related to quality control testing, including test methods, and equipment operation and maintenance procedures.

Minimum Requirements

• 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 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 QA and QC functions for cleanroom operations, including reviewing and tracking Environmental Monitoring data and cleanroom maintenance practices.
• Support QA and QC functions for laboratory operations, including equipment maintenance, review and tracking of samples, testing results, materials inventory and reagent preparation.
• Support Quality Assurance (QA) documentation functions for cGMP production, in-process testing and release testing of cell therapies.
• Liaise with CROs for sample submissions and external testing results reporting.
• Other duties as required.
• Support process implementation for sample receipt, and in-process and release testing of raw materials, cell lines, process intermediates, drug products and other materials.