Quality Assurance Associate Systems

Atom Vie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases.

About the Role
The Quality Assurance Associate Systems helps to ensure GMP compliance for production of new and ongoing radiopharmaceuticals s position will act as an interface between quality, radiopharmaceutical development, regulatory and production to ensure that all regulated activities listed below are conducted in compliance with relevant regulations and internal procedures.

What You Will Do

Through ongoing monitoring and review, ensure that the quality systems are in compliance with regulatory requirements and meet the needs of Atom Vie and its clients.

Work collaboratively with stakeholders to keep systems current and effective with applicable regulations.

Manage and track non-conformances, laboratory investigations, CAPAs, change controls, and complaint system.

Lead job board and change control committee meetings with internal stakeholders.

Prepare quality performance metrics and provide monthly reports to Quality Assurance Management.

Participate in and lead internal audits, including scheduling, conducting, and reporting.

Participate in on-site audits by regulatory authorities and clients, including preparation and follow-up activities.

Perform compliance reviews of aseptic process, operator qualification, media fills, equipment qualification, calibration records.

Perform compliance reviews of equipment PM and calibration records.

Participate in and lead GMP training program for new employees or as required.

Meet regularly with the Manager QA Systems to provide updates on ongoing activities, track and set priorities, and address issues and problems.

Acquire an appropriate understanding of quality processes, developing approaches to achieve compliance that ensure relevant standards are met.

Serve as primary contact for QA activities associated with introduction of new QA requirements; review non-conformance, prepare and close out CAPAs and change controls.

Assist on project deliverables to ensure high quality standards and compliance with internal/external requirements and GMP regulations.

Provide guidance and support to QA staff, ensuring the QA system and areas are maintained to Atom Vie standards and regulatory requirements, mentoring and coaching staff on the importance and implications of quality at Atom Vie.

Ensure compliance with Health and Safety policies, procedures and regulations applicable to their work.

Other duties as assigned.

Experience Necessary

Post‑Secondary Education in Engineering, Chemistry, Microbiology or a related field.

3 to 5 years of relevant experience.

Experience working in a GMP environment is required.

Experience preparing or reviewing quality documentation is an asset.

Training and experience in quality systems, quality audits, good documentation practices, change controls, CAPAs, and review of quality records.

Strong understanding of Health Canada and FDA GMP regulations, with specific knowledge of regulations pertaining to sterile products.

Proficiency in the English language, both written and oral, and excellent communication skills; detail‑oriented.

Ability to work independently and possess excellent organizational skills.

Strong client‑facing and teamwork skills.

Compensation
Annual salary starts at $60,000.

RRSP Matching.

Opportunity for long‑term growth.

Collaborative environment with experienced individuals in the field.

Atom Vie is committed to fostering a workplace that values diversity, equity, and inclusion. Accommodations are available upon request. We ensure that every qualified applicant has an equal opportunity to thrive within our organization.

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