Validation Specialist – BC Cancer – Vancouver

Job title:

Validation Specialist – BC Cancer – Vancouver

Company

Provincial Health Services Authority

Job description

Validation SpecialistBC CancerVancouver, BCReporting 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.This role may require working remotely and hours may vary slightly.What you’ll do

• 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.

What you bringQualifications:

• 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.
• Demonstrate comprehensive knowledge of the historic and ongoing impacts of settler colonialism and systemic racism on Indigenous Peoples within social and health contexts. This includes understanding how these factors contribute to current health disparities and barriers to care. Show a clear commitment to identifying, challenging, and eradicating Indigenous-specific racism and all forms of discrimination impacting equity-deserving groups within healthcare settings. This involves recognizing personal biases, institutional barriers, engaging in anti-racism education and training and advocating for systemic change.
• Knowledge and understanding of legislative obligations and provincial commitments within BC Cancer contexts found in the foundational documents including Truth & Reconciliation Commission’s Calls to Action (2015), In Plain Sight (2020), BC’s Declaration on the Rights of Indigenous Peoples Act (2019), United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP), Reclaiming Power and Place Missing and Murdered Indigenous Women & Girls Calls for Justice (2019), the Declaration Act Action Plan and Remembering Keegan: A First Nations Case Study, BC Human Rights Code, Anti-racism Data Act and how they intersect across the health care system.

Core Competencies:

• Brings an understanding of the Indigenous specific racism and the broader systemic racism that exists in the colonial health care structure and has demonstrated leadership in breaking down barriers and ensuring an environment of belonging. Embed Indigenous Cultural Safety and Humility into all aspects of work. This means creating an environment where Indigenous patients feel respected, valued, and understood. Foster trust through respectful communication, active listening, and honoring equity-deserving people’s perspectives on health and wellness. Commit to ongoing education and training on Indigenous health issues, cultural safety, and DEI principles. Participate in workshops, cultural immersion experiences, and continuous professional development to stay informed and responsive to equity-deserving groups. Provide patient-centred care that respects Indigenous ways of knowing and healing, respects BIPOC experiences and world views ensuring that care plans are culturally relevant and holistic.
• Knowledge of social, economic, political and historical realities of settler colonialism on Indigenous Peoples and familiarity with addressing Indigenous-specific anti-racism, anti-racism and Indigenous Cultural Safety and foundational documents and legislative commitments (The Declaration Act, the Declaration Action Plan, TRC, IPS, Remembering Keegan, etc.).

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.
• Demonstrate a commitment to beginning and continuing their personal learning journey related to Indigenous-specific racism and dismantling systems of oppression, as well as addressing racism more broadly. Shows willingness to articulate and share their learning experiences to contribute to a culture of motivation and inspiration among peers.
• Knowledge of the social, economic, and political realities of settler-colonialism and its impacts on Indigenous peoples and equity-deserving groups within social and health contexts. Understands the impact of social determinants of health-on-health outcomes. Shows a commitment to learning about and upholding legislative obligations and provincial commitments outlined in foundational documents such as the Truth & Reconciliation Commission’s Calls to Action (2015), In Plain Sight (2020), BC’s Declaration on the Rights of Indigenous Peoples Act (2019), United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP), Reclaiming Power and Place: Missing and Murdered Indigenous Women & Girls Calls for Justice (2019), the Declaration Act Action Plan, Remembering Keegan: A First Nations Case Study, the BC Human Rights Code, Anti-Racism Data Act, and the Distinctions Based Approach.

What we bringEvery 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.

Job Type: Regular, Full-timeWage: $39.26 to $49.01 per hourLocation: 600 West 10th Avenue, Vancouver, V5Z 4E6Applications will be accepted until position is filled.Hours of Work: Monday to Friday; 0800-1600; This role may require working remotely and hours may vary slightly.Requisition Number: 180584EWhat we doprovides comprehensive cancer control for the people of British Columbia.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 – Create equity – Be courageous.Learn more about PHSA and our programs:PHSA is committed to anti-racism and equity in our hiring and employment practices. With learning and compassion, we are addressing existing inequities and barriers throughout our systems. PHSA is seeking to create a diverse workforce and to establish an inclusive and culturally safe environment. We invite applications and enquiries from all people, particularly those belonging to the historically, systemically, and/or persistently excluded groups identified under the B.C. Human Rights Code.One of PHSA’s North Star priorities is to eradicate Indigenous-specific racism, which includes ongoing commitments to Indigenous recruitment and employee experience as well as dismantling barriers to health care employment at every level. We welcome Indigenous individuals to apply and/or contact the Sanya’k̓ula Team (Indigenous Recruitment & Employee Experience) for support at .Indigenous-specific anti-racism initiatives are rooted in addressing the unique forms of discrimination, historical and ongoing injustices, and exclusion faced by Indigenous peoples. These initiatives align with an Indigenous rights-based approach, recognizing the inherent rights and title of BC First Nations and self-determination of all First Nations, Inuit and Métis communities. PHSA is mandated to uphold legislative obligations and provincial commitments found in the foundational documents including the Truth & Reconciliation Commission’s Calls to Action (2015), In Plain Sight (2020), BC’s Declaration on the Rights of Indigenous Peoples Act (2019), United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP), Reclaiming Power and Place Missing and Murdered Indigenous Women & Girls Calls for Justice (2019), the Declaration Act Action Plan and Remembering Keegan: A First Nations Case Study.Attention current employees of PHSA:You must apply via your internal profile at .The internal job posting expires on March 17, 2025, and will no longer be accessible. If the internal job posting has expired, please e-mail with the six-digit job requisition number and your PHSA employee ID number to be considered as a late internal applicant. Please do not apply for the external job posting.If you have not yet set up an internal profile, please e-mail with your PHSA employee ID number to obtain your temporary password. Our business hours are Monday-Friday 8:30am-4:30pm, excluding Statutory Holidays and a Help Desk Representative will respond to you with 1-2 business days.If you are not a current employee of PHSA and require assistance with your application, please contact the External Careers team at .
Labor Agreement Health Science Professionals
Requisition # 180584E-2430650
Work Site 750 West Broadway, Vancouver, BC V5Z 1K1
Job Type Regular, Full-Time
Salary/Rate $39.26 – $49.01 / Hour
FTE 1.00
Hours of Work 0800-1600
Work Days Mon, Tue, Wed, Thu, Fri
Expiry Date 05-Apr-2025

Expected salary

$39.26 – 49.01 per hour

Location

Vancouver, BC

Job date

Sat, 08 Mar 2025 23:39:30 GMT

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