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    Green Cross Biotherapeutics Inc.

    QA Specialist – Plasma

    Green Cross Biotherapeutics Inc. Saint-Laurent, Quebec

    Engineering and science
    Posted 27 day(s) ago | Still Open
    Permanent 40 h - Full time As soon as possible

    Description

    Position Summary

    The Quality Assurance (QA) Specialist- Plasma is responsible for the all QA Plasma Operation activities, from oversight of receiving plasma shipments from approved donation centers to oversight of plasma verification through to the plasma allocation to manufacturing to ensure that all plasma documents, systems and activities/operations are in full compliance with regulatory standards and Green Cross Biotherapeutics (GCBT) requirements.

    Key Duties and Responsibilities
    • Supports all QA Plasma Operation activities, from oversight of plasma receipt from approved donation centers to QA oversight of plasma verification through to the plasma allocation for manufacturing.
    • Responsible to manage plasma lookback process for all plasma programs.
    • Support QA Operations Manager with vendor relationships with external testing labs.
    • Oversight of physical plasma supply chain processes, including lookbacks and plasma inventory reconciliation.
    • Responsible for QA oversight and support for the procurement of human source plasma from approved plasma centers.
    • Supports deviation investigations associated with issues/deviations arising during plasma logistics.
    • Manage the plasma lookback process. Review and approve investigations, support the gathering of required information and maintain files required for regulatory purposes.
    • Ensure the integrity and traceability of all data generated and reported
    • Generate new procedures and revise existing procedures, as required
    • Develop and Report Quality Metrics for plasma process, as required
    • Follow appropriate gowning requirements in GMP areas
    • Perform additional duties as assigned
    Qualifications
    • Education: At minimum, must have a B. Science, (Preferred: Microbiology, Chemistry, Biology)
    • At least 6 - 10 years’ experience in QA within the Biopharmaceutical or Pharmaceutical Industry
    • Specialist level expertise with advanced knowledge of quality systems (change control, deviations, investigations, root cause analysis, CAPA and risk assessments).
    • Demonstrates judgment, technical competence and knowledge critical for role.
    • High proficiency in office software packages, including word processing, spreadsheets, and SAP required.
    • Must be able to work independently with strong decision-making skills.
    • Excellent analytical and communication skills are essential.
    • Strong organizational skills, including attention to detail and ability to meet deadlines
    • Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes
    • Able to multi-task under strict deadlines
    • Achieves and exceeds goals
    • Improves organization's practices, processes and quality
    • Facilitate cross-functional collaboration and manage assigned projects
    • Good oral and written communication skills and good interpersonal skills
    • Bilingual in both French and English
    Green Cross Biotherapeutics Inc.

    Green Cross Biotherapeutics Inc.

    Established in 2014, GCBT is a Montreal-based biopharmaceutical company and a member of the GC family. Canada’s only IVIG and Albumin Manufacturing Plant GCBT has recently completed the construction of the only intravenous immunoglobulin (IVIG)...

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