KIK Custom Products

  • In Process Quality Assurance Specialist

    Job Location US-TX-Ft. Worth
    Posted Date 3 weeks ago(5/9/2018 3:10 PM)
    Job ID
    2018-5260
    # of Openings
    1
    Division
    KCM
  • Overview

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    The In-Process Quality Assurance oversees all quality aspects of manufacturing, including, but not limited to: warehousing, dispensing, manufacturing, packaging and incoming inspection activities.  The IPQA provides immediate direction for potential quality issues on the shop floor, including first assessment of potential deviations and initial determination of product impact and immediate corrective actions, including the management of product, equipment and system/facility holds. The IPQA provides Quality Assurance oversight in the production and incoming inspection processes, ensuring that products, materials, batch records and labeling are properly managed according to cGMPS and other internal and external regulations and standards. The IPQA is also responsible to maintain a Quality Assurance presence on the shop floor and partner with Area Management to drive the Quality culture and mindset at the site.  This posiiton is on first shift and works 7:30 AM- 3:30 PM.

    Essential Job Functions

    IPQA is appropriately trained and aligned to support plant operations.
    Aligns with site goals and supports Quality, Compliance and Production objectives, focused on Quality Throughput.
    The IPQA Specialist follows the Strategic direction and is in alignment with site and QA objectives, to ensure that business and compliance needs are met.
    Ensures product, facility, and equipment holds are placed when batch, equipment or systems are potentially impacted.
    Works with Supply Chain Management and communicates regarding Quality batch status and other potential production impacts to allow for adjustments in production planning.
    Ensures periodic formal and informal audits are completed, and works with Area Management to ensure audit and walkthrough observations are addressed in a timely manner.

    Monitors and evaluates Quality Systems and procedures to ensure industry standards and cGMPs are met.
    Supports and meets Departmental, Plant and Corporate HS&E goals. Works in a safe and efficient manner.

    Qualifications

    • Bachelor degree in science or other technical field
    • A minimum of two years Quality Assurance experience in a GMP FDA production environment.
    • Auditing experience a plus.
    • Certified Quality Engineer/Manager/Auditor a plus.
    • Requires the ability to influence others to achieve results.

     

    KIK is an Equal Opportunity / Affirmative Action Employer

     

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