Quality Assurance Associate

3 weeks ago

Hamilton, Canada AtomVie Global Radiopharma Inc. Full time

AtomVie 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**
Reporting to the Supervisor, Quality Assurance Tech-Transfer, the* Quality Assurance Associate - Tech Transfer* will support tech transfer activities for both investigational and commercial products at the facilities run by AtomVie. This position will support radiopharmaceutical development, regulatory, and production to ensure that all activities are conducted in compliance with relevant regulations and internal procedures.
**What You Will Do**
- Support technology transfer and validation activities of investigational and commercial products and processes; including review and assessment of executed batches records and any relevant associated data (e.g., testing data OOS, non-conformances, change controls and CAPAs, etc.)
- Support assigned projects and ensure that high quality standards are met within the projected timelines and project outcomes are compliant with internal/external requirements and GMP regulations
- Participate in client and internal project team meetings and address any issues in a timely manner
- Detect, report, and proactively propose solutions to challenges to ensure compliance with AtomVie’s internal standards as well as regulatory standards.
- Review standard operating procedures (SOPs), MBRs, STMs and other controlled documents for compliance with CAPAs, change controls, regulations and as per client requirements as needed
- Review validation and stability protocols for compliance.
- Review reports for compliance with protocols, quality systems, regulations and client requirements.
- Conduct internal training of staff where needed
- Update job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; and participating in professional organizations
- Develop and maintain an in-depth knowledge of key regulations and guidance documents, pertinent to Product Development and Quality Assurance and use this knowledge to improve the quality management system
- Initiate and support improvement initiatives in favor of the development and growth of the AtomVie’s quality management system.
- Support the growth and development of AtomVie’s Quality Management System in accordance with Health Canada and FDA regulations, ICH Q10 and ISO guidance
- Complete any other related duties that support the core activities and mission of AtomVie, as required

*
Experience Required*
- Post-secondary education in Engineering, Chemistry, Microbiology or a Science field
- Minimum 3-5 years of relevant experience working in Biotech/Pharmaceutical/Radiopharmaceutical industry; experience in sterile products is considered an asset
- Deep understanding of Health Canada, FDA and EU GMP regulations

*
What You Bring to the Role*
- You are familiar with GMP, Method & Process Validation and Technology Transfer
- Ability to support improvements and interact with internal and external stakeholders
- Excellent communications skills in both written and spoken English
- Agile responsiveness and flexibility to industry and business needs while maintaining a detail-oriented and compliant outlook
- Strong client-facing, teamwork and organizational skills

*
AtomVie Offers:*
- Group Health & Dental Benefits
- RRSP Matching
- Parking Reimbursement
- Training & Career Development
- Opportunity for long-term growth
- Join a passionate team making a difference in patients’ lives

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