Molecular Imaging Quality Assurance Specialist
3 months ago
Molecular Imaging Quality Assurance Specialist
BC Cancer
This position is integral to the Molecular Imaging & Therapy Quality Program at BC Cancer. The role necessitates a physical presence at designated locations, with the possibility of remote work as deemed suitable.
The Quality Assurance Specialist is responsible for overseeing and managing the Laboratory Information Management System (LIMS) within the Functional Imaging Department. This digital platform is essential for the production, evaluation, and advancement of radiopharmaceuticals that comply with Good Manufacturing Practice (GMP) standards. Reporting directly to the Quality Assurance Manager, this role plays a crucial part in the coordination and management of the Department's Quality Management System (QMS).
Key Responsibilities
- Administer the LIMS, which includes user management, development and modification of electronic product methodologies, inventory oversight, instrument management, and training initiatives.
- Serve as the primary liaison for LIMS with external partners, coordinating with the LIMS vendor and IT support for system updates, user training, hardware requirements, and troubleshooting.
- Organize regular system updates, user training sessions, and address hardware and database connectivity issues as they arise.
- Create and implement validation protocols to ensure compliance with regulatory standards for electronic systems and equipment.
- Conduct thorough investigations into deviations, non-conformances, and failures, utilizing interviews, process reviews, and root cause analysis to summarize findings and recommend corrective actions.
- Draft and revise Standard Operating Procedures and Test Methods for managerial review and approval.
- Additional responsibilities may include assisting with document control system management, data analysis for quality trends, maintaining supplier records, and reviewing completed batch records.
Qualifications
The ideal candidate will possess:
- A Bachelor's degree in Science, Computer Science, Engineering, or a related field.
- Three to five years of experience in the pharmaceutical or medical device sectors.
Skills and Attributes
- Proficiency in operating an electronic QMS or LIMS.
- A demonstrated ability to learn and apply new techniques effectively.
- Knowledge of data integrity principles related to GMP or Good Laboratory Practices.
- Strong time management and organizational skills.
- Excellent technical writing skills and meticulous attention to detail.
- Ability to collaborate constructively in a cross-functional team environment.
- Capacity to independently prioritize and manage workload.
- Awareness and commitment to understanding the Truth & Reconciliation Commission's 94 Calls to Action and related reports.
- A strong commitment to fostering meaningful reconciliation in Canada.
- Familiarity with the social, economic, political, and historical contexts affecting Indigenous communities is a valuable asset.
What We Offer
At PHSA, every employee contributes to delivering exceptional patient care. Whether through direct patient interaction, research, or supporting operational functions, your work positively impacts the lives of individuals across British Columbia.
- Join one of the largest employers in the province, with extensive opportunities for professional growth, development, and recognition.
- Access to a wide range of professional development programs, including over 2,000 courses.
- Comprehensive benefits package, including a municipal pension plan and wellness resources.
- Generous vacation entitlement and statutory holidays.
- Flexible work options to support employee well-being.
- Access to a premium discount program offering various local and national discounts.
About Us
BC Cancer is dedicated to providing comprehensive cancer control for the residents of British Columbia. As part of the Provincial Health Services Authority (PHSA), we collaborate with health authorities to ensure equitable and effective healthcare services across the province. Our core values emphasize respect, compassion, innovation, partnership, and purposeful service.
PHSA and BC Cancer are committed to employment equity, encouraging all qualified individuals to apply. We recognize that a diverse workforce enhances our ability to provide the best care for our varied patient populations and strive to maintain a safe, inclusive, and welcoming environment.
Reconciliation is a shared responsibility, and we are dedicated to working collaboratively with Indigenous Peoples to foster a sustainable path toward lasting reconciliation.
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