Careers

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

Duties:

  • 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)

 

Keywords:

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:

Required Skills:

OUTSTANDING COMMUNICATION

OUTSTANDING COMMUNICATION SKILLS

ANIMAL TESTING

IMMUNOLOGY

ORGANIZATION SKILLS

Additional Skills:

QUALITY CONTROL

BIOASSAY

DOCUMENTATION

METHOD VALIDATION

STATISTICS

TECHNICAL WRITER

VALIDATION PROTOCOLS

VALIDATION/TESTING

Languages:

English

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