QA Specialist – GMP/ISO Quality Assurance Expert

BWX Technologies, Inc.; Ottawa, Vancouver; On-site; CAD 73,000 - 106,000; Full time

Benefits offered by this job

Health benefits

Pension plan

Flexible hybrid schedules

Referral bonuses

Educational refund plan

Professional development

Gym discounts

Welcoming workplace

Team-building activities

Job summary

BWXT Medical Ltd. in Kanata, Ontario, is seeking a Quality Assurance Specialist to design and maintain QA procedures that satisfy FDA, Health Canada, ISO 9001/13485 and CE requirements.

You will coordinate the Medical Isotopes Quality System, conduct internal audits, support validation activities, and drive corrective actions to ensure compliance and continuous improvement across production, supplier and development activities.

Qualifications

• Undergraduate degree in Life Sciences or Engineering relevant to QA.
• ASQ certification or equivalent is an asset.
• Keep up-to-date with FDA, Health Canada, Europe regulations to ensure QA compliance.
• In-depth understanding of GMP for pharmaceuticals, active ingredients, medical devices and ISO quality standards.
• Strong judgment, problem solving and analytical skills.
• Ability to understand complex operations from a broad perspective.
• Thorough knowledge of quality auditing methodology.
• Excellent organizational and written/verbal communication skills.
• Ability to analyze data, identify trends and determine corrective actions.
• Proficiency in computer systems.

Responsibilities

• Coordinate one Medical Isotopes Quality System and maintain QA procedures.
• Establish quality procedures for controlling product and process quality; advise on quality plans and continuous improvement.
• Support validation activities review and change control.
• Perform internal quality and supplier audits to uphold quality objectives.
• Initiate actions to improve efficiency across your area by adjusting methods and systems.
• Provide QA training to internal groups and conduct GMP/Quality System training.
• Develop and maintain QA systems, procedures and documentation for regulatory compliance.
• Identify customer requirements through feedback and audits to meet those needs.
• Provide QA guidance to other departments and external contractors.
• Perform drug or device product release activities and back-up QA Manager duties.

Skills

Quality Assurance

Regulatory knowledge

GMP knowledge

Auditing

Analytical skills

Problem solving

Communication

Education

Bachelor's degree in Life Sciences or Engineering

Job description

BWXT Medical Ltd. in Kanata, Ontario, is seeking a Quality Assurance Specialist to design and maintain QA procedures that satisfy FDA, Health Canada, ISO 9001/13485 and CE requirements.

You will coordinate the Medical Isotopes Quality System, conduct internal audits, support validation activities, and drive corrective actions to ensure compliance and continuous improvement across production, supplier and development activities.