QA Shift Supervisor

BWXT Medical Ltd. provides its customers, who conduct life-saving medical procedures for patients around the world, the benefit of decades of experience in the development, manufacturing, packaging and delivery of medical isotopes and radiopharmaceuticals. Headquartered in Kanata, Ontario, BWXT Medical Ltd. employs over 300 highly-skilled people in Kanata and Vancouver, British Columbia. BWXT Medical Ltd. is part of the BWXT nuclear power segment (NPG) of BWX Technologies, Inc.

• Responsible for Batch Record Review and product release activities for radiopharmaceuticals and medical devices. 
• Contributes to the development of effective QA programs. Responsible for the maintenance of QA programs such as Corrective Actions, Failure investigations, Internal Quality Audits and Change Control Validation, requiring a thorough knowledge of Company QA procedures and Company Products and Manufacturing Processes. 
• May participate as a member of a project team.
• Supports QA Managers and is responsible for supervision of QC staff  
• Acts to foster strong and cooperative relationships with external customers and internal stakeholders.

• Responsible for the supervision of Quality Control technicians performing tests on materials, components and finished products.
• Reviews all radiopharmaceutical Batch Records for completeness and verifies certain calculations and results. Responsible for product release (radiopharmaceutical) and for ensuring that product released meets approved specifications. Responsible to communicate status of release to customers.
• Supports audits (GMP, ISO). Participates in customer and regulatory audits of products and quality systems.
• Reviews and recommends changes to production processes to improve product quality.
• Participates in validation activities including the review and approval of critical equipment validations.
• Ensures that traceability is maintained over all QC processes in accordance with GMP's and initiates corrective action to ensure compliance.
• Conduct or oversee investigations, preparation of decision summaries and issuing corrective action requests to implement required actions.
• Independently directs out-of-spec and process anomalies and failure investigations. Tracks reports for closure.
• Participates in the management review team meetings to provide tracking for customer complaints, corrective actions, etc.
• Provides development and technical support to activities including but not limited to assay development, co­ordination of and leading of projects, and writing, executing and summarizing protocols as necessary.
• Exercises technical supervision of other staff as required.
• Analyses design and/or development with regard to the sources of supply, methods, location and cost of fabrication and testing.
• Responsible for the preparation and maintenance of good records of all calculations, design studies, experiments, tests and estimates; these may be in the form of drawings, specifications, reports and memoranda.
• Establishes and maintains the necessary interdepartmental liaison relating to this position’s responsibilities.
• Advises supervisor or other management of progress, costs, problems and delays with respect to individual projects.
• Utilizes technical expertise to provide training, guidance and instruction to others.
• Identifies system, facility or operational gaps that represent risks to ongoing operation or development of the radiopharmaceutical operational area, brings these gaps forward to the QA Director and General Manager and aids in activities to address these gaps.
• Provides technical expertise to respond to customer queries related to the quality and use of products and may act as a go between to assist commercial operations.
• Utilizes technical expertise to lead, assist or consult in investigative or corrective actions.
• Performs other related duties.

• Normally an undergraduate BSc degree in chemistry or microbiology with 5-7 years relevant experience.
• Must have proven leadership skills. Ideally, the incumbent will have had previous experience in pharmaceutical, device or health care products.
• Must have strong interpersonal qualities of leadership and initiative and set appropriate standards for performance to ensure staff is motivated to meet objectives.
• Must be able to plan, organize and direct quality control activities effectively.
• Must have an understanding of Chemistry and or Microbiology and a good working knowledge of radiation physics.
• Must have experience working with GMP's. Sterile manufacturing would be an asset.
• Must have capacity to understand, interpret and explain complex technical systems or phenomena.
• Must be able to analyze situations and make decision often with minimal information and little time for optimization or corrective action. Must be resourceful, creative and possess superior problem solving skills.
• Proven record of making difficult, independent and sound decisions under pressure.
• Knowledge of working with a union and within a collective agreement is considered an asset.

The base salary range for this position in Ontario (CA-ON) at the start of employment is expected to be between $$82,000.0 and $$126,000.0 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.

Learn more about how BWXT employs nuclear technology to solve some of the world’s most important problems. BWXT’s capabilities video showcases our innovation in commercial nuclear power, addressing climate change, as well as our advanced nuclear medicine products treating patients around the world. We are People Strong. Innovation Driven.

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.