KIK Custom Products

  • Quality Control Manager

    Job Location US-IL-Danville
    Posted Date 3 weeks ago(6/26/2018 2:10 PM)
    Job ID
    2018-5373
    # of Openings
    1
    Division
    KCM
  • Overview

    Custom New Logo

     

    General Summary 

    Manage and direct all Quality Control laboratory (chemistry and microbiology labs) activities to ensure adherence to all customer and regulatory requirements and finished good product specifications which includes all aspects of manufacturing and packaging. Will work with customers. QC management oversight includes Analytical, Microbiology and Incoming Inspection laboratories. Will oversee a total staff of 21 in the labs.

    Essential Job Functions

     Essential Job Functions

     

    • Manage QC and Incoming personnel and oversee daily testing activities to support the manufacture of regulated and non- regulated products.
    • Ensure specific analytical tests and wet chemistry tests on raw materials, in-process, final products, stability goods and incoming testing are assigned to meet the schedule.
    • Ensure QC personnel perform investigations of out-of-specification and out-of-trend data and communicate effectively and timely to upper management.
    • Assist in determining root causes to laboratory investigations and appropriate CAPAs and assessing the effectiveness of the CAPAs.
    • Work effectively to resolve issues and ensure consistency of testing techniques and assess occurrences and root causes of OOTs or OOSs
    • Develop budget for QC and manage the expenditure for laboratory operation.
    • Ensure all testing by chemists is completed according to the schedule and meet all cGMP requirements.
    • Ensure analytical instruments’ calibration and maintenance under cGMP regulations.
    • Monitor and review analytical instruments’ qualifications and ensure them to meet regulatory requirements.
    • Communicate material issues or delays to the appropriate internal customers (e.g., materials management, production, packaging, QA) in a timely manner.
    • Propose and implement solutions to meet customer requests.
    • Interface with contract labs regarding QC sample handling and reporting.
    • Ensure stability testing is performed per procedure requirements.
    • Review and approve data. Evaluate and interpret the test results and other related technical documentation.
    • Maintain test data, records and related laboratory documents.
    • Communicate with external suppliers or service providers regarding quality issues.
    • Responsible for managing teams’ performance and applicable quality metrics.
    • Work cross-functionally with departments to help resolve issues.
    • Establish SOPs and standard test methods for the QC laboratory operations and supervise and train staff.  Modify procedures as needed to improve overall lab efficiency and compliance. 
    • Manage special projects as requested by site Quality leadership. 
    • Mentor and develop employee skills. 

     

    Qualifications

    Requirements:

    • BS degree in Chemistry or Microbiology. Masters Degree ideal
    • 5+ years of combined chemistry and microbiology experience in regulated industry. 
    • At least 3 years managing or supervising a medium sized laboratory (chemistry or microbiology) with high volume throughput. 
    • Must be highly organized, detail oriented and able to manage multiple projects
    • Experience using HPLC, GC, UV, IR, Auto Titrators, office software (MS Excel, MS Word, etc)
    • Hands on Aseptic technique experience
    • Strong problem solving ability in analytical chemistry with  strong written and verbal communication, and organization skills.
    • Ability to maintain detailed and accurate records
    • Knowledge of FDA regulations, ICH guidelines, CFR, USP/NF and validation guidelines
    • Good technical writing skills and customer relationship experience

     

    WWW.KIKCORP.COM

     

    www.KIKCORP.com

     

     KIK is an Equal Employment Opportunity / Affirmative Action Employer

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