Radiopharmacy Specialist II - Quality Assurance Associate

Tracer Hub is seeking a Quality Assurance Associate to support the day-to-day operations of the Quality Management System (QMS). Reporting to the Provincial Quality Assurance Manager and supervised by the Quality Assurance Lead, this position is part of a high-functioning QA team and supports the compliance and improvement of the quality management system (QMS), ensuring high quality products and compliance with current Good Manufacturing Practices (GMPs). In this position, you will support quality activities for implementing, monitoring, and improving GMP compliant operations in a manufacturing facility. You will collaborate with Manufacturing, Regulatory, and Quality Control to align QMS practices, manage and implement change and drive continuous improvement. Success in this role requires strong problem-solving skills, technical writing skills, attention to detail, organizational skills with the ability to plan, prioritize workload, and balance competing demands along with ability to effectively communicate with staff and teams. Key Responsibilities include: Performing QA tasks that supports GMP compliant operations in a manufacturing facility; Writing, reviewing and revising protocols, procedures, reports and master batch records (MBRs); Reviewing validation and qualification documentation for facility, equipment, processes, suppliers, etc.; Reviewing completed MBRs, ensuring the MBR meets specifications and QMS requirements; Coordinating and reviewing the QMS nonconformance system; Completing internal audits in all GMP areas; Participating in Quality Risk Management activities to support site operations; Providing GMP training for new employees; Supporting regulatory on-site audits. Note: This position is on a 4-week shift rotation of nights (3:30 am - 11:45am) and days (8:15 am - 4:30pm).

As a Radiopharmacy Specialist II, you will be responsible for the day-to-day coordination of an assigned area and/or quality control functions for the department. You will work to coordinate and prioritize daily assignments of staff, resolve complex issues, monitor the production of radiopharmaceuticals for regulatory compliance and ensure that operations are compliant with Radiation Safety and Production standards.

Bachelor of Science Degree in Chemistry or a related field or equivalent level of education and experience. Certification with the Canadian Association of Medical Radiation Technologists (CAMRT) or certification with the Canadian College of Radiopharmaceutical Scientists (CCRS) where applicable.

Note: No certification with CAMRT or CCRS is required for this position. B.Sc. Degree with a specialization in microbiology/chemistry preferred or an education and experience equivalency. Minimum five (5) years of relevant experience in Quality Assurance (QA) or equivalent work experience.

Training and experience in leadership, conflict resolution, change management and effective communication. Process improvement courses and/or certification. Knowledge of Good Manufacturing Practices (GMPs), US Pharmacopeia (USP) regulations and good documentation practices. Strong organizational skills with the ability to plan, prioritize workload, and balance competing demands. Demonstrates professionalism, tact, and courtesy when interacting with customers, colleagues, and external agencies.