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    Quality Control Manager - Hamilton, ON, Canada - AtomVie Global Radiopharma Inc.

    AtomVie Global Radiopharma Inc.
    AtomVie Global Radiopharma Inc. Hamilton, ON, Canada

    6 days ago

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    Description
    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.

    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.

    The QC Supervisor will oversee a team of highly skilled analysts performing quality control testing, stability testing, investigations, and method transfer.

    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.

    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.

    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.
    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.

    years of previous hands-on laboratory experience in pharma/biotech QC testing laboratories, performing routine testing, method transfer, method development, and validation.

    ~Experience in analytical techniques for chemical testing (e.g. and biological testing (ELISA, IRF, SDS-PAGE, Bacterial Endotoxins, cell culture, etc.), Health & Dental Benefits (from day 1)
    AtomVie is committed to fostering a workplace that values diversity, equity, and inclusion. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process.
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