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    Senior Compliance Engineer - Round Lake, United States - Kelly Science, Engineering, Technology & Telecom

    Kelly Science, Engineering, Technology & Telecom
    Kelly Science, Engineering, Technology & Telecom Round Lake, United States

    4 weeks ago

    Kelly Science, Engineering, Technology & Telecom background
    Description

    Location: Onsite - Round Lake, Illinois

    Type: Contract - (NO C2C OR THIRD PARTY ACCEPTED)

    Duration: 6+ months - Opportunity for contract extension long term

    Pay Rate – Negotiable depending on DIRECT-related experience

    Work Authorization - Must be able to work in the U.S. with approved authorization status as a citizen or lawful permanent resident of the United States. Visa Status is not allowed for this role as current or future sponsorship is unavailable.

    This role is NOT a validation engineering role

    • Candidates cannot be allergic to Penicillin or Cephalosporins.

    Preferred:

    • Project management experience
    • Experience with due diligence, auditing, compliance management, or regulatory experience
    • Hands-on experience in drug product aseptic manufacturing operations

    JOB SUMMARY:

    • Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System.
    • Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines, and compendia as requirements.

    RESPONSIBILITIES:

    • Work with internal auditors to develop programs to ensure continued compliance with policies and regulations.
    • Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost-effectiveness.
    • Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness.
    • Evaluate quality data and determine strategies, actions, and initiatives to drive improvements in the facility

    Qualifications:

    • Experience with pharmaceutical and/or device quality and compliance management systems
    • Knowledge of cGMP and global regulatory guidelines such as EMA, FDA, and other health agencies.
    • Knowledge of Six Sigma methodology and LEAN principles.

    Education and Experience:

    • • At least 5 years of directly related experience within the pharmaceutical industry or medical device experience
    • • BS in Science or Engineering. Advanced degree a plus.

    Important information: To be immediately considered, please send an updated version of your resume to

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