Validation Specialist, Molecular Imaging
1 month ago
Validation Specialist, Molecular Imaging & Therapy Quality
BC Cancer
Provincial, BC
This role will be supporting the Molecular Imaging & Therapy Quality Program for BC Cancer – IAMI. This role will require on-site presence at 4004 Wesbrook Mall, Vancouver BC V6T 2A3, with remote work as appropriate.
Reporting to the departmental Quality Assurance Manager, the Validation Specialist supports the validation program within BC Cancer's radiopharmaceutical manufacturing laboratory as well as the manufacture, testing and development of Good Manufacturing Practices (GMP) compliant PET radiopharmaceuticals.
Key Responsibilities
- Draft and update validation protocols to ensure Health Canada regulatory compliance for equipment, analytical methods, and production processes, and submit to manager for approval.
- Ensure qualification and validation activities are scheduled appropriately in relation to the clinical manufacturing schedule in consultation with the Production Unit Manager, and executes validation activities in according to approved protocols.
- Orient radiochemistry staff on the Functional Imagining department's equipment, processes, and test method validation protocols to establish compliance with Health Canada GMPs. This includes ongoing coaching with respect to validation requirements and regulatory expectations.
- Keep current on regulations and guidance documents related to validation and qualification. Identifies trends, best practices, and process improvement opportunities and coordinates their implementation to ensure continued compliance and efficiency of the validation program.
- Conduct root-cause investigations associated with deviations, non-conformances, and failures resulting from validation and qualification activities through interviews, process review and root cause analysis, summarizes findings, and recommends follow-up and/or corrective action.
- Write final validation reports, including data analysis, discussion of results, and final conclusions. Submit reports to the Quality Assurance Manager, for review and approval, and for incorporation into the regulatory submission process.
- Prepare radiopharmaceuticals for clinical use following established procedures and Good Manufacturing Practices. Production activities are coordinated with the departmental Production Unit Manager.
Requirements
- A level of education, training, and experience equivalent to a Bachelor's degree in Chemistry or a related discipline.
- Three to five (3-5) years of experience in a pharmaceutical GMP manufacturing environment.
You have:
- Working knowledge of equipment qualification, test method and process validation, and other processes related to Good Manufacturing or Good Laboratory Practice.
- Previous experience with radiochemistry production and quality control highly desired.
- Excellent organizational and time management skills
- Awareness of and commitment to learning and understanding the Truth & Reconciliation Commission's 94 Calls to Action (2015), In Plain Sight Report (2020), BC's Declaration on the Rights of Indigenous Peoples Act (2019), and other related reports.
- Commitment to upholding the shared responsibility of creating lasting and meaningful reconciliation in Canada as per TRC (2015) and BC's Declaration on the Rights of Indigenous Peoples Act (2019).
- As a strong asset for consideration, we are looking for our successful candidate to have: Knowledge of social, economic, political and historical realities impacting indigenous communities and familiarity with Indigenous Cultural Safety and anti-racism and accompanying reports (BC DRIPA, TRC, etc.).
About PHSA
Every PHSA employee enables the best possible patient care for our patients and their families. Whether you are providing direct care, conducting research, or making it possible for others to do their work, you impact the lives of British Columbians today and in the future. That's why we're focused on your care too – offering health, wellness, development programs to support you – at work and at home.
- Join one of BC's largest employers with province-wide programs, services and operations – offering vast opportunities for growth, development, and recognition programs that honour the commitment and contribution of all employees.
- Access to professional development opportunities through our in-house training programs, including +2,000 courses, such as our San'yas Indigenous Cultural Safety Training course, or Core Linx for Leadership roles.
- Enjoy a comprehensive benefits package, including municipal pension plan, and psychological health & safety programs and holistic wellness resources.
- Annual statutory holidays (13) with generous vacation entitlement and accruement.
- PHSA is a remote work friendly employer, welcoming flexible work options to support our people (eligibility may vary, depending on position).
- Access to WorkPerks, a premium discount program offering a wide range of local and national discounts on electronics, entertainment, dining, travel, wellness, apparel, and more.
Location: Provincial Position and candidate must be within the vicinity of the BC Cancer Centre to work on-site as required.
Applications will be accepted until position is filled.
Hours of Work: Monday to Friday; 800-1600
About BC Cancer
provides comprehensive cancer control for the people of British Columbia.
BC Cancer is part of the Provincial Health Services Authority (PHSA).
The Provincial Health Services Authority () plans, manages and evaluates specialized health services with the BC health authorities to provide equitable and cost-effective health care for people throughout the province. Our values reflect our commitment to excellence and include: Respect people – Be compassionate – Dare to innovate – Cultivate partnerships – Serve with purpose.
Learn more about PHSA and our programs:
PHSA and BC Cancer are committed to employment equity, encouraging all qualified individuals to apply. We recognize that our ability to provide the best care for our diverse patient populations relies on a rich diversity of skills, knowledge, background and experience, and value a safe, inclusive and welcoming environment.
Reconciliation is an ongoing process and a shared responsibility for all of us. The BC Governments' unanimous passage of the Declaration on the Rights of Indigenous Peoples Act was a significant step forward in this journey—one that all health authorities are expected to support as we work in cooperation with Indigenous Peoples to establish a clear and sustainable path to lasting reconciliation. True reconciliation will take time and ongoing commitment to work with Indigenous Peoples as they move toward self-determination. Guiding these efforts Crown agencies must remain focused on creating opportunities that implement the Truth and Reconciliation Commission Mandate.
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