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    Quality Assurance Specialist 1 - West Lafayette, United States - Cook Group

    Cook Group
    Cook Group West Lafayette, United States

    1 month ago

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    Description

    Overview:

    Cook Research Incorporated is currently accepting applications for a Quality Assurance Specialist 1 to become a part of our growing Quality Assurance team. This position is responsible for assuring that the quality policy and system are maintained within the organization.

    Responsibilities:

    Review and inspect protocols, reports, project documentation, data, and regulatory submissions for accuracy and compliance to applicable procedures, standards, and regulations;

    Ensure QMS procedures are compliant with applicable regulations and external standards;

    Assess impact of proposed procedural changes to CRMS and other related documents;

    Maintain a working knowledge of CRMS processes and procedure, regulations, and standards;

    Act as a Quality consultant for processes;

    Train staff on CRMS processes;

    Comfortable working in collaborative and independent work situations;

    Ability to multi-task and work across departments with multiple stakeholders; and

    May participate in internal audits - Auditing Certification is of advantage.

    Qualifications:

    Associates degree in Engineering, Physical or Life Science field, or closely-related technical field preferred;

    One (1) year of experience in a regulatory environment within the medical, biotechnical, or pharmaceutical industry;

    Experience in a regulated environment preferred (e.g. ISO 13485; ISO 17025;

    Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards; and

    Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position


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