QA Specialist

5 months ago

Ottawa, Canada BWX Technologies Full time

**BWXT Medical Ltd. **is a trusted source for the development and manufacture of nuclear medicine for biotechnology, life sciences, pharmaceutical companies and academia partners. Headquartered in Kanata, Ontario, BWXT Medical Ltd. employs over 300 highly-skilled people in Kanata and Vancouver, British Columbia.

BWXT Medical is hiring an **Quality Assurance Specialist **at our manufacturing facility in Kanata, ON.

**Work Location**: On-Site. 447 March Road, Kanata

**JOB PURPOSE**:
The Quality Assurance Specialist position is responsible for design and maintenance of the Quality Assurance System procedures or products and their compliance with the requirements of the various regulatory bodies and Standards such as the FDA, Health Canada, ISO 9001, ISO 13485 and the European requirements for Drugs and devices which may include CE Mark requirements.

**JOB STRUCTURE & COMMUNICATIONS**:

- Reports to Director, Quality Assurance.
- Required to make important quality related decisions and recommendations, which will affect the ability of the company to efficiently and economically, deliver products and services.
- Make recommendations regarding what actions to take, based on concerns raised in the operation of any of the quality systems or products that are manufactured.
- Approves Quality related documentation: Change Control's, audit reports, complaints, Corrective and Preventive Actions, nonconformance documents and other related documents.
- Must be able to make product release decisions and know when to escalate the decision within the Quality organization when there are deviations or errors that could impact the quality of the product.

**ACCOUNTABILITIES**:

- Typically, responsible for the coordination of one Medical Isotopes Quality Systems (as described above).
- Determine and establish the appropriate quality procedures for controlling product and process quality. Provide guidance and assist the operating division in preparing quality plans and continuous improvement plans for their work areas.
- Support development groups with review/approval of validation activities, change control.
- Perform internal quality and supplier audits to ensure that company quality objectives are maintained.
- 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.
- Support customer and 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.
- 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.

**KNOWLEDGE AND EXPERIENCE**:

- Normally an undergraduate degree in Life Sciences or Engineering with 2-5 years experience in Quality Assurance or Quality Controll or other relevant area in pharmaceutical, medical device environment. Advanced degrees would be considered an asset.
- Certification in quality auditing, American Society of Quality (ASQ) certification (or equivalent) is considered an asset.
- 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.
- excellent organizational and communication skills (verbal and written).
- Ability to analyze data, trend, and determine corrective actions.
- Demonstrated proficiency in computer systems.

**Why join BWXT Medical?**
- Work within the growing and exciting nuclear medicine industry as well as with highly skilled employees.
- Competitive salaries.
- Company match pension plan.
- Comprehensive health and dental benefits.

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