Quality Control Supervisor

3 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 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


Are you a seasoned professional in the pharmaceutical or biotech QC laboratory space with a passion to lead? AtomVie Global Radiopharma Inc. is seeking a Quality Control Supervisor to join our team. Ideal candidates will possess in-depth expertise of HPLC and strong leadership skills to effectively oversee and mentor a team of analysts/technicians at our growing company. The QC Supervisor will oversee a team of highly skilled analysts performing quality control testing, stability testing, investigations, and method transfer.


What You Will Do


  • Provide leadership by setting clear expectations, providing guidance, and fostering a positive team environment.
  • Oversee quality control testing of incoming materials, drug substances, finished drug products according to standard methods, ensuring adherence to GMP standards.
  • Manage client projects, communications, presentations, and meetings while providing technical support.
  • Provide analytical support for new analytical techniques, new projects, and method transfer activities.
  • Coordinate and schedule daily activities of analysts/technicians to ensure that the team is able to plan, implement and complete assigned tasks in a timely fashion ensuring consistent high quality as per the cGMP and company SOPs.
  • Conduct investigations for testing failures and non-conformances, implementing corrective actions and assessing CAPA effectiveness.
  • Provide training, coaching and enforcing policies while monitoring performance and conducting reviews to support career development.
  • Maintain documentation for regulatory compliance including nuclear safety requirements.
  • Verify laboratory records and ensure compliance with GMP regulations.
  • Author, revise, create and review technical documents, including INVs, NCs, CAPAs, validation and stability documents (protocols, reports), STMs, and other technical documents with input from SMEs.
  • Ensure that routine quality operations including equipment maintenance, calibration and facility housekeeping are properly maintained.
  • Assist team members in troubleshooting equipment systems (HPLCs, GCs, LSC, Gamma Counter, Gamma Spec, etc.).
  • Maintain and expand the team’s job knowledge in analytical quality topics, industry regulations, participating in educational opportunities, and reading professional publications.
  • Oversee the application and continuous improvement of Health & Safety practices, with an emphasis on radiation safety, radiation contamination monitoring, and appropriate handling of hazardous materials. Provide training to staff, ensuring compliance with all policies, procedures, and regulations.
  • Complete all other duties, as required.


What You Bring to the Role


  • Ability to lead, coach and motivate a team.
  • Ability to cultivate strong working relationships with internal and external stakeholders, fostering collaboration and mutual respect.
  • 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
  • Knowledge of chromatographic Data Software for relevant equipment, use of spreadsheets (Excel), databases, and word processing software.


Requirements


  • M.Sc. or Ph.D in Chemistry , Biological Chemistry, Biotechnology, or a related discipline.
  • 5 - 10 years of previous hands-on laboratory experience in pharma/biotech QC testing laboratories, performing routine testing, method transfer, method development, and validation.
  • 3 years of demonstrated leadership experience.
  • Experience in analytical techniques for chemical testing (e.g. HPLC, GC, TLC, ICP, wet chemistry, etc.) and biological testing (ELISA, IRF, SDS-PAGE, Bacterial Endotoxins, cell culture, etc.), as well as material characterization (Gamma Spectroscopy, NMR, MS, IR, MALDI, etc.)
  • Flexibility to support a 24/7 production environment.
  • Ability to lift 23 kilograms required


AtomVie Offers


  • Health & Dental Benefits (from day 1)
  • RRSP Matching Program
  • Perkopolis
  • Employee Assistance and Wellness Programs
  • Parking Allowance


AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.

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