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QA Specialist
3 months ago
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 a 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 the 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.
- 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.
- 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.
- 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 Control 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 (APIs), 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.
- Work within the growing and exciting nuclear medicine industry as well as with highly skilled employees.
The base salary range for this position in Ontario (CA-ON) at the start of employment is expected to be between $66,117 and $94,453 per year. However, the base salary offered is based on local job market factors and may vary further depending on factors specific to the selected job candidate, such as job-related knowledge, skills, experience, and other objective business considerations. Subject to these considerations, the total compensation package for this position may also include other elements, such as an annual cash incentive in addition to a full range of medical, retirement, and/or other benefits. Details of participation in these benefit plans will be provided at such time the selected job candidate receives an offer of employment.
BWXT Medical Ltd. embraces diversity of thought, values individuality, encourages new perspectives and provides equal opportunity in employment for all qualified employees and applicants without regard to race, national or ethnic origin, colour, religion, age, sex, sexual orientation, marital status, family status, disability, a conviction for which a pardon has been granted or a record suspended or any other category protected by federal law. BWXT Medical Ltd. is committed to fostering an accessible, fair, and inclusive environment where all employees are able to access goods while being respected and supported. If you require accommodations during the application or interview process, please advise us as soon as possible so appropriate arrangements can be made. If you require information in a format that is accessible to you, please contact Human Resources.
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