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Quality Control Supervisor

2 weeks ago

Hamilton, Canada AtomVie Global Radiopharma Inc. Full time

AtomVie 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 of radiotherapeutics for the detection and treatment of cancer and human diseases.

We are a community that challenge ourselves professionally, are proud of what we can accomplish together, and take pride in the impact that we can make with our clients and patients across the globe. We can’t wait for you to begin your career with AtomVie and to help us achieve our vision: to transform lives by revolutionizing healthcare.

**About the Role**

**What You Will Do**
- Oversee client projects and client communications, prepare presentations, attend client meetings and provide client technical support as needed.
- Day-to-day coordination and schedule of activities of assigned analysts/technicians to ensure that the team is able to plan, implement and complete assigned tasks in a timely fashion ensuring consistent high quality in accordance with GMP and company SOPs.
- Conduct investigations for testing failure and non-conformances, and implement corrective actions. Supervise and provide technical guidance throughout the investigation process. Monitor progress and ensure timely completion of investigations, non-conformances, CAPAs, and change controls. Identify areas for improvement of departmental practices and testing methods to support efficient operations and product quality. Implement corrections actions and assess effectiveness of CAPAs.
- Manage training plans for self and for assigned staff and ensure sufficient cross-training is in place to allow for completion of daily tasks. Responsible for training other colleagues, colleagues from other departments, and new staff. Provide regular updates on training plans, current resource allocation/gaps and improvement initiatives to management team.
- Responsible for the housekeeping of the facility including the disposal of hazardous waste (chemical and radioactive) through the appropriate waste streams. Monitor effectiveness of the housekeeping and waste procedures and propose improvements to management.
- Responsible for maintenance of documentation to fulfill applicable regulatory requirements relating to nuclear safety (e.g. radioactive material transfer forms).
- Responsible for Technical Review: Verify laboratory records and ensure adherence of assigned staff to GMP regulations by reviewing records pertaining to all aspects of analytical and microbiological testing, routine operations, and equipment maintenance.
- Perform quality control (release & retrospective) testing of of incoming materials, drug substances, finished drug products according to standard testing methods (STMs), including analytical chemistry, biological and microbiological tests and other tests according to the USP, EP. Ensure that contact testing is completed as required.
- Provide analytical support for production and support for the launch of new projects.
- Support the analytical method development team in any activities related to method transfer, and/or validation activities according to approved workorders or protocols.
- Author, revise, create and review technical documents, including INVs, NCs, CAPAs, validation documents (protocols, reports), STMs, SOPs, specifications, risk assessments, change controls, etc. according to regulatory guidelines (ICH, USP, etc.) with input from SMEs, for review by management, QA and/or customers. Write test reports, data summaries, and statistical evaluations/trending.
- Ensure that routine quality operations including installation/calibration/maintenance of equipment, reagent inventory, and facility housekeeping are properly maintained.
- Troubleshoot equipment systems (HPLCs, GCs, LSC, Gamma Counter, Gamma Spec, etc.).
- Manage training plans for assigned staff and ensure sufficient cross-training is in place to allow for completion of daily tasks. Identify and assist in conducting cross functional training to maintain and improve the growth of employee knowledge and the flexibility of staff to support process development and production.
- Continually work on broadening technical expertise of self and the team to support current products and develop future drugs within the AtomVie portfolio or through support of our CMO functions.
- Update job knowledge in analytical quality topics, industry regulations, participating in educational opportunities, and reading professional publications. Continue to develop management skills through courses, training, reading, interaction with colleagues, etc.
- Accomplish human resource objectives by training, assigning, scheduling, coaching,communicating job expectations, monitoring performance, conducting performance reviews, supporting career development activities; and enforcing policies and procedures.
- Participate in Health Physics meetings, and notify Health Physics and Management of unsafe radiological work and ens