North York, Ontario
Quality controls Scientist
Quality Control Scientist I
Location : North York, Toronto, ON
Start Date: 11/01/2019
Estimated End Date: 05/01/2020
Hours Per Week: 40.00
Hours Per Day: 8.00
Department: QC Lead Projects
Job Category: Manufacturing/Quality
- Provides contributions to the understanding and interpretation of results and how they impact the design of subsequent experiments.
- Designs, executes, and interprets experiments to develop, validate, transfer and troubleshoot quality procedures and test methods.
- Carries out investigations and produces documentation.
- Develops and authors complex, explicit documentation for new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics.
- Solves assay/process problems. Identifies potential problems and proactively suggests technical solutions based upon analytical expertise and knowledge of product/process.
- Routinely coordinates completion of specific project tasks with other departments. Contributes to development of project strategy in consultation with supervisor and/or colleagues.
- Work is performed under minimal supervision.
- Independently determines and develops approach to solution.
- Work is reviewed upon completion for adequacy in meeting objectives.
- Contributes to the completion of specific programs and projects.
- Failure to obtain results or erroneous decisions or recommendations would typically result in program delays and expenditure of resources.
- Frequent inter-organizational contacts.
- Represents the organization in providing solutions to difficult technical issues associated with specific projects.
QC Analytical Excellence Biological Testing Support Team – Scientist Responsibilities include:
- Lead method optimizations, improvements and revalidation Lead ALCM method assessment periodic review
- Address method validation gaps identified during ALCM method assessment periodic review
- Address validation/testing gaps for new products Support/Lead replacement of test methods with new test/technology
- Support/Lead implementation of new tests/technology
- Support/Lead post approval commitments and other regulatory commitments
Skills: QC Analytical Excellence Biological Testing Support Team – Scientist skill set should include:
- Outstanding communication skills
- Outstanding technical writer (protocols, reports, investigations)
- Experienced in test method development and troubleshooting
- Experienced in peforming immunonology assays (example: ELISAs and cell-based bioassay methods)
- Experienced in conducting scientific investigations, including OOS investigations and CAPAs
- Experineced in animal testing
- Outstanding Technical Skills (including various computer prgrams and systems)
- Outstanding Organization Skills (required to work on multiple projects at the same time)
Education: QC Analytical Excellence Biological Testing Support Team – Scientist Education Requirements:
Immunology/Biology – BSc with minimum of 7 years of relevant experience, or MSc with a minimum of 3 years of relevant experience
Skills and Experience:
OUTSTANDING COMMUNICATION SKILLS