KIK Custom Products

  • CJD 2018 Compliance Coordinator

    Job Location US-GA-Gainesville
    Posted Date 4 weeks ago(3/29/2018 4:44 PM)
    Job ID
    2018-5150
    # of Openings
    1
    Division
    KCM
  • Overview

    Custom New Logo

     

    COMPLIANCE COORDINATOR

     

    Responsible for supporting the Quality Systems Manager in the areas of validation, internal regulatory compliance, Quality System improvements, metrology, Investigation and CAPA program, and finally plant quality metrics.

     

     

     

    Essential Job Functions

    • Technical Writing, to include minor investigative, annual product reviews and SOP's
    • Assist with the Validation Master Plan and its maintenance
    • Maintain the tracking and timely completion of validation activities
    • Track to completion all product non-conformance reports
    • Responsible for the maintenance of the plant metrology program
    • Coordinate special projects as requested
    • Conduct internal audits as directed by the site procedures
    • Assist with the development and maintenance of SPC in the manufacturing operations
    • Track and maintain the Plant Investigations and CAPA program.  Assist as needed in the investigations and report writing.
    • Product and document Retain system
    • All Plant Quality Metrics-tracking and distribution to management
    • Assist in customer and regulatory audits as needed
    • Responsible for monitoring cGMP's

     

     

     

    The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.

    Qualifications

    • Two-year degree or significant experience required in area of discipline
    • 3 years related experience. 
    • Experience working in FDA regulated environment
    • Must have basic knowledge of production equipment, filling equipment and processing
    • Must be proficient in MS Office (Excel, Word, PPT)
    • Must be able to interact with customers, suppliers and plant personnel at all levels
    • Above average detail, organization, planning and time-management skills

     

     

    Thank you for your interest and consideration of a career with KIK

    KIK is an Equal Opportunity / Affirmative Action employer. 

    Qualified applicants will receive consideration for employment without regards to race, color, religion, sex, or national origin.

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