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    Senior Quality Engineer - Philadelphia, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Philadelphia, United States

    3 weeks ago

    Default job background
    Description
    Responsibilities:
    • Identifying risk, developing complex mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups such as Manufacturing, Quality Control, IT, Engineering and Validation.
    • Supporting the oversight of Data Integrity and Computer System Validation efforts, system lifecycle and improvements.
    • Supporting cGMP quality improvement efforts at iCTC and in remote facilities such as Philadelphia, PA and the Tampa Labs
    • Creating and maintaining company documentation, such as quality manuals, and quality procedures.
    • pplying good manufacturing practice and observing that it is being adhered to.
    • Strong experience developing and executing protocols for single-use process systems, lab systems and software applications in a cGMP environment.
    • Demonstrable experience creating and maintaining policies, processes and procedures for a new cGMP facility.
    • Demonstrable experience utilizing risk-based assessments and setting up lifecycle verification programs for manufacturing and laboratory systems.
    • bility to effectively communicate with management and project team members.
    • Experience in preparing for and participating in regulatory inspections to ensure successful outcomes.
    • Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results.
    • Must be comfortable in a fast-paced environment with minimal direction and changing priorities.
    • Experience identifying changes, driving improvements, and streamlining processes required.
    • Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project
    • Represent Quality on cross-functional teams to complete projects, address quality issues and implement quality system improvements.
    • Provide technical guidance to cross-functional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity including root cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes and disposition of discrepant material.
    Requirements:
    • BA/BS degree in scientific or engineering discipline
    • 5+ years of biopharmaceutical industry experience in a technical or supporting technical role.
    • 3+ years leading or supporting GxP Computer System implementation and validation.
    • 2+ years of experience in a Quality role is highly desirable.
    • Demonstrable experience creating and utilizing inspection/testing systems.
    • Experience with cell and/or gene therapy products
    • GMP regulated laboratory experience
    • Knowledge of investigation writing
    • This position will work in both an office and a manufacturing lab setting.
    • When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
    • ble to work in cleanroom with biohazards, human blood components, and chemicals.
    • Potential exposure to noise and equipment hazards and strong odors.
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