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Doral

    Jr Quality Engineer - Doral, United States - PL Developments

    PL Developments
    PL Developments Doral, United States

    1 month ago

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    Description

    JOB QUALIFICATIONS:
    Bachelor's Degree in Science, Engineering or related field from an accredited college or university
    5+ years related experience preferably in a quality assurance environment; or, an equivalent combination of education and/or experience
    Must be an effective communicator and understand written procedures
    Very knowledgeable in cGMPs, FDA regulations and guidance and other regulatory requirements in a regulated manufacturing environment
    Investigations to determine cause corrective action and prevention planning.
    Attention to detail
    Excellent interpersonal and communication skills
    Ability to follow routine verbal or written instructions
    Able to work under pressure and meet deadlines
    Computer literate
    Able to work with minimal supervision


    POSITION RESPONSIBILITIES:


    Analyzes data from production and laboratories, reports deviations (Manufacturing, Laboratory) and consults with other departments to identify recurrent problems, and coordinates resolution of complex quality issues.

    Researches and recommends improvements in production.
    Oversees Quality Systems related to the Product/ Technology Transfer Process.
    Complies with all Company policies and procedures, including safety rules and regulations.
    Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements in a regulated manufacturing environment.
    Supports the training department in assessing Quality training requirements and revising them as needed. Provides training to manufacturing operators in MBR's.
    Supports the Computer systems Validation by reviewing and approving related Qualification/Validation Protocols and Reports.
    Support site deviation system as site system administration.
    Create and review new production and packaging records.
    Review and work together with production department in the preparation and writing of deviations/investigations.
    Support the QA department compiling data, reviewing and approving APR's for OTC products.


    PHYSICAL REQUIRMENTS:
    Complies with all Company policies and procedures, including safety rules and regulations

    Work is performed in a standard office environment

    Subject to standing, walking, bending, reaching, stooping, and lifting of objects up to 25 pounds

    Experience

    Required

    cGMPs, FDA regulations and guidance and other regulatory requirements in a regulated manufacturing environment

    • 8 years: Experience preferably in a quality assurance environment
    Education

    Required

    Bachelors or better

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