Sr QA Specialist

BWXT•Ottawa, ON

2d•CA$85,000 - CA$129,000•Onsite

About The Position

The Sr. Quality Assurance Specialist plays a key role in developing, maintaining, and evolving the Quality Assurance Systems for products and processes to ensure compliance with various regulatory bodies and standards, including FDA, Health Canada, ISO 9001, ISO 13485, and European CE Mark requirements for drugs and medical devices. This role will collaborate with cross-functional teams, including Engineering, Research and Development, Production, Quality Control, Procurement, Information Technology, and Human Resources, to ensure that products and processes meet or exceed regulatory requirements. This role also focuses on continuous improvement by identifying opportunities for enhancing the quality of products in development and improving existing products. You will actively monitor current trends in cGMP regulations and bring relevant updates to the attention of the organization.

Requirements

Normally an undergraduate degree in Life Sciences or Engineering with 3-5 years experience, or College diploma (may be considered when combined with significant industry experience) with greater than 5 years experience in Quality Assurance or Quality Control or other relevant area in a pharmaceutical or medical device environment.
Must maintain up-to-date knowledge with respect to regulations for the FDA, Health Canada, and Europe to ensure Quality Systems, design and development and Validation practices are current and compliant.
In-depth understanding of the Good Manufacturing Practices (GMP) regulations for Pharmaceuticals, Active Pharmaceutical Ingredients (APls), medical devices and ISO quality standards.
Possess sound judgment, problem solving and analytical skills.
Must have the ability to understand complex operations from a broad perspective.
Thorough knowledge of quality auditing methodology.
Capable of organizing and directing his/her efforts between a large number of conflicting tasks.
Ability to train people with different levels of responsibility, including managers in various quality related subjects.
Capable of building, facilitating and/or coordinating teams of employees in quality improvement projects and issues.
Knowledge of QA Techniques including statistical techniques, problem solving, root cause analysis and lean sigma.

Nice To Haves

Advanced degrees would be considered an asset.
American Society of Quality (ASQ) certification (or equivalent) is considered an asset.

Responsibilities

Typically, responsible for the coordination of one Medical Isotopes Quality Systems (as described above).
Ensure closure of system and product non-conformances through the use of the formal corrective action process, and facilitates completion of requested actions.
Determine and establish the appropriate quality procedures for controlling product and process quality. Provide leadership and assist the operating division in preparing quality plans and continuous improvement plans for their work areas.
Provides independent guidance to Development groups for quality assurance requirements (regulatory requirements and industry best practices) in all phases of a development project. Guidance must be consistent with the direction of the Medical Isotopes QA Team.
Initiate and follow through on actions relating to improved efficiency of assigned area of responsibility by adjusting methods, procedures, systems and working conditions.
Perform internal quality audits to ensure that company quality objectives are maintained. Performs supplier audits, as required.
Host or assist with customer audits and assist with regulatory audits.
Establish and maintain quality data collection and analysis using appropriate information systems to improve product design, manufacturing, supplier and quality systems and report at the Management Review as required.
Provide training on Quality Assurance procedures for internal groups such as: Production, Quality Control, Research and Development and other personnel. Also provide general GMP/Quality System training, as required.
Develop, plan and maintain all necessary QA Systems, procedures and documentation to meet applicable quality and regulatory standards.
Identify customer requirements by monitoring customer feedback, hosting customer audits and ensure that the company is working to meet these requirements.
Provides Quality Assurance guidance and support to other departments and outside contractors.
May be required to perform drug or device product release activities.
May be responsible to provide back-up support for the Quality Assurance Manager position.
Performs other related duties as appropriate to this level.

Benefits

Comprehensive Health Benefits – Including health, dental, vision, and disability coverage
Defined Contribution Pension Plan
Optional Company-matched retirement savings plans (RRSP/TFSA/EPSP)
Flexible hybrid schedules
Compressed workweek option available
Generous referral bonuses with our two-tiered Employee Referral Program ($1,500 and $3,000!)
Up to $5,250 USD per year through our Educational Refund Plan.
Professional Development – Gain access to training, certifications, and growth opportunities
Gym membership discounts
Access to mental health support programs.