Qc Specialist I (Biotech)
By Apex Systems At Toronto, Ontario, Canada
Preference for experience in the Biotechnology or pharmaceutical industry setting, particularly cell therapy, stem cells, gene editing.
Practical understanding of qualification and/or validation of analytical assays is an asset.
Experience with Good Documentation Practices and working in a cGMP or equivalent environment is preferred.
Experience in statistical analysis of data is desired.
Excellent written and oral communication skills, with strong organizational skills and keen attention to detail.
Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint).
Qc Specialist Jobs
By Apex Systems At Toronto, Ontario, Canada
Support testing execution as required for transfer of QC test methods, characterization assays and/or qualification of methods.
Liaise with CROs for sample submissions and external testing results reporting.
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 cleanroom operations, including reviewing and tracking Environmental Monitoring data and cleanroom maintenance practices.
This position will be working 80%+ on-site as lab work is required.