- Review and approve completed production records for manufacturing and support related processes to ensure compliance with Good Documentation Practices and established requirements.
- Participate in routine batch review activities for BWXT Medical final products to support on time release for shipment.
- Support Operations Manager by acting as designate to oversee manufacturing and planning activities when required. Participate in on-call rotation for off-hours operations support.
- Represent interests of Operations area for new projects and processes.
- Lead CAPA investigations and implement corrective actions.
- Lead documentation of process deviations and implement corrective actions.
- Lead and/or support complaint investigations and implement corrective actions.
- Lead and/or support completion of safety reports and hazard assessments.
- Train employees on changes impacting Operations.
- Review established processes and revise procedures to improve usability and ensure compliance.
- Design and implement solutions to facilitate operational compliance and reduce risk of errors
- Monitor trends and implement corrective and/or preventive actions in response to findings where required.
- Minimum Bachelor of Science in relevant science discipline.
- Experience and expertise working in a manufacturing environment.
- Experience working in environments under formal design processes and change control.
- Knowledge of the regulatory environment and requirements associated with the manufacturing of medical isotopes, radiopharmaceuticals, and/or medical devices is considered an asset.
- Excellent verbal communication skills. Must be effective in communicating with both internal and external parties including customers and regulators. Excellent writing skills.
- Leads continuous improvement activities and completes required documentation and testing to support implementation of improvements.
- Leadership skills and ability to negotiate complex issues with stakeholders having cross-functional interests and priorities.
- Project management and leadership capabilities for short as well as multi-month projects to lead continuous improvement initiatives.
- Strong analytical and problem solving skills to enable trouble shooting and problem resolution within tight timelines.
Operation Specialist - Ottawa, Canada - BWX Technologies
Description
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 Ltd. is hiring an Operations Specialist (12 month term position) at our production facility in Kanata, Ontario.
Work Location: On-site, 447 March Road
Status: Temporary - 12 month term
Job Purpose
Reporting to the Senior Manager, Operations Supprt, the Operations Specialist supports manufacturing by ensuring compliance with Good Manufacturing Practices and Quality System requirements. The Operations Specialist is responsible for leading and documenting process deviations, investigations, product and material non-compliances and implementing corrective and preventive actions that support the reliable supply of medical isotope products. Must work with cross functional teams to accomplish goals and obtain organizational support for Operations related initiatives.
Responsibilities
Manufacturing Support
Operations Compliance
Continuous Improvement
Qualifications
The candidate must possess and demonstrate the following:
The base salary range for this position in Ontario (CA-ON) at the start of employment is expected to be between $78,000.00 and $121,000.00 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.