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Quality Assurance Manager

Spiderwort Inc
Ottawa, ON
Full-time, Fixed term contract

Location

Ottawa, ON

Benefits
Pulled from the full job description

  • Stock options

Full job description

Spiderwort is developing novel plant-derived biomaterials to address a variety of tissue engineering applications. We are building an interdisciplinary team of experts who are passionate about bringing medical biomaterials to the clinic in order to dramatically impact human health and well-being.

Spiderwort seeks professionals with a clear track-record of excellence. The successful candidate will work independently and as part of an interdisciplinary team to meet important corporate objectives.

For this position, Spiderwort is seeking a Quality Assurance Manager to support the company’s operations. Candidates should have extensive experience working in similar roles in the Medical Device industry.

The position is a full-time with an anticipated start date in May 2021.

Primary Responsibilities:

  • Leading the implementation of Quality Management System (QMS) standards, such as documentation management, management of non-conformances, change control, Corrective Actions and Preventive Action (CAPA), and validation of site master plan.
  • Develop investigational protocols and reports.
  • Coordinate document review processes.
  • Management of laboratory variances and supplier-generated investigations.
  • Maintain the records of all batch review and approve release of products.
  • Manage quality documentation, maintain regulatory compliance intelligence, manage audits, manage supplier/vendor quality.
  • Review of material deemed defective and management of the troubleshooting process ensuring regulatory compliance.
  • Revising and creating new standard operation procedures (SOPs).
  • Compile data and reviewing it for abnormalities.
  • Actively participate in Risk Management processes.

Essential Qualifications:

  • 5+ years of life sciences industry experience in a comparable role.
  • Motivated, action-oriented, self-starter able to develop and execute plans and strategies.
  • Detailed knowledge of relevant Canadian and American regulations pertaining to Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Good Clinical Practice.
  • Scientific degree in life sciences or a related field, formal regulatory training is an asset.
  • Mastery of common software application.
  • Outstanding communication skills and comfort collaborating within a highly interdisciplinary team.
  • Ability to function in an environment requiring a high-level of adaptability and multitasking.
  • Professional designations, including ASQ and CAPRA, is an asset.
  • Fluency in English and French.

Expected start date: 2021-06-01

Job Types: Full-time, Contract

Benefits:

  • Stock options

Schedule:

  • Monday to Friday

Work remotely:

  • No