Job Order Detail

Description

The Quality Assurance Associate (QAA) will oversee MLDs internal Quality programs, including its ISO13485 framework for the manufacturing of medical device test kits. They will also be responsible for implementing a pharmaceutical quality program to support MLDs therapeutic development, overseeing, arranging, conducting and reporting on audits of cGMP facilities, nonclinical, and clinical research organizations, vendors, and systems as well as provide oversight of the clinical operations and clinical trials. They will review and organize study documents, check for consistency with appropriate standards and practices, assist in the creation and maintenance of audit tools, and as appropriate, prepare and/or revise SOPs.
Overview of Responsibilities:
    Draft, implement, approve, and maintain SOPs appropriate for company and program stages.
    Conduct regular training of MDL personnel and consultants on SOPs.
    Implement and maintain comprehensive document control system.
    Performs Quality Control (QC) of clinical and non-clinical data.
    Ensures Clinical Operations and Clinical Trials are compliant with FDA and Health Canada regulatory expectations.
    Oversees MLDs ISO13485 IVDD manufacturing processes.
    Oversee the product releases of all manufactured materials, relabeled/repackaged products for storage and shipping of products.
    Review and maintain completed batch records.
    Work directly with CROs and other external contractors and collaborators, managing the chain of communication related to regulatory compliance.
    Conduct internal audits, risk assessments and annual quality reviews and prepare applicable reports, including recalls (if any).
    Keep the management informed of any significant risks and non-conformities.
    Host inspections by FDA, Board of Pharmacies and customers.
    Performs other QA/QC duties as required.