Quality Control Supervisor

1 month 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 transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.

We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.

**About the Role**

**What You Will Do**
- Oversee and participate in quality control 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.
- Maintain current programs: mange client projects and client communications, prepare presentations, attend client meetings and provide client technical support as needed
- Onboard new programs: Provide analytical support for the implementation of new analytical techniques, launch of new projects, and support the method development team in any activities related to method transfer according to approved workorders or protocols.
- Day-to-day coordination and scheduling of activities to 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.
- Ensure that methods and equipment are suitable for quality control tasks and in compliance with Good Manufacturing Practices (GMP) for investigational and commercial products
- 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.
- 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.
- 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 Data 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.
- Responsible for Technical Writing: 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.).
- Maintain and regularly update or expand the team’s 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.
- Participate in Health Physics meetings, and notify Health Physics and Management of unsafe radiological work and ensure that unsafe acts and conditions are handled promptly and correctly.
- Monitor adherence to radiation safety compliance, identify and implement process improvements, and provide training to staff.
- Complete all other duties, as required.

**What You Bring to the Role**
- Ability to lead and motivate a team.
- Ability to work independently and possess excellent organizational skills
- Excellent communication skills (written and verbal)
- Demonstrated ability to successfully prioritize, manage time well, multitask and troubleshoot
- Knowledgeable in use of HPLC, GC, and other analytical techniques, Chromatographic Data Software for relevan

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