Jobs

    Quality Assurance Specialist - Birmingham, AL, United States - BuildSubmarines

    BuildSubmarines
    BuildSubmarines Birmingham, AL, United States

    3 weeks ago

    BuildSubmarines background
    Description
    Complaint Handling


    • Work with multifunctional teams (R&D, Manufacturing, Operational Compliance, and Engineering to drive resolution to product complaints
    o Facility/cleanroom validation

    o Equipment qualification


    This position is responsible for providing quality and technical support to the production team providing oversight to manufacturing rooms and laboratories by reviewing and approving data and all other Quality Management System documentation.

    The position utilizes risk management, quality planning and statistical analysis to complete assigned tasks.

    Routine Quality Assurance functions, to include but not limited to:

    Provide real time production floor QA oversite

    Evaluate manufacturing data for trends and other special causes

    Review and disposition manufacturing / packaging batch documentation

    Review and disposition raw materials / components for manufacturing

    Support resolution of quality issues in manufacturing

    Represent quality department on development project teams

    Support the generation and justification of product and materials specifications

    Support interdisciplinary teams for root cause analysis of quality deficits using known of problem solving tools

    Failure reports for products in the field

    Identification of potential failure modes and risks

    Support product quality and System improvements activities

    Support collection and analyze data to identify opportunities for quality improvement

    Complaint Handling

    Work with multifunctional teams (R&D, Manufacturing, Operational Compliance, and Engineering to drive resolution to product complaints

    Risk Management

    Support to facilitate risk assessment activities such as design and process FMEA

    Ensure product risks are identified and risk mitigation controls are put in place to eliminate product risk to an acceptable level

    Facility/cleanroom validation

    Equipment qualification

    Bachelor of Science degree in Chemistry, Biology, or Engineering , preferred.

    Minimum two to three years' experience in pharmaceutical or medical device manufacturing

    Minimum two to three years' experience in a pharmaceutical or medical device Quality Assurance role

    Proficient computer skills, Microsoft Word, Excel, Access

    Knowledge or understanding of FDA's cGMP and / or QSR quality system requirements

    Experience in Regulatory Agency inspections , preferred

    Your Application


    To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal .

    Please address your application to the Talent Acquisition Manager, statingyour earliest possible starting date and your salary expectations.
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