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    Quality Assurance Coordinator II - Brownsburg, United States - Life Science Logistics LLC

    Life Science Logistics LLC
    Life Science Logistics LLC Brownsburg, United States

    2 weeks ago

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    Description

    Job Description

    Job Description

    RESPONSIBILITIES:

    • Perform all duties from a Quality perspective
    • Gain a thorough understanding of all LSL Quality documents and procedures
    • Gain a thorough understanding of regulatory requirements related to warehousing and distributing pharmaceuticals, medical devices and healthcare products
    • Provide Quality training for all facility personnel as assigned
    • Review records and forms for accuracy to ensure compliance with established LSL procedures and regulations
    • Maintain the Quality files as applicable: Scan, Save to appropriate online storage, file
    • Perform warehouse process walks to ensure SOPs are being followed as written and the facility is maintained in a clean, safe, compliant manner
    • Notify the Quality Assurance unit of any Quality or inventory concerns
    • Request Deviations for any Quality related issues
    • Assist CQCU in developing plans and programs for process improvement
    • Collaborate with all departments to ensure effective Corrective Actions are completed as necessary
    • Assist CQCU with Internal and External Audits
    • Assist CQCU with Annual PQ's
    • Assist CQCU with change requests, reactive maintenance, Deviations/CAPA
    • Perform Hold and Releases
    • Assist CQCU with temperature monitoring of controlled environments
    • Assist in returns and damages process
    • Other duties as assigned

    QUALIFICATIONS AND JOB SPECIFICATIONS:

    • High School diploma, GED, or equivalency required. Working on a college degree preferred.
    • Minimum of 1 year experience in Quality logistics role
    • Exhibits a strong work ethic with leadership ability
    • Demonstrates sound problem-solving skills
    • Displays dedication to a high standard of performance
    • Intermediate public speaking and presentation skills
    • Excellent verbal and written communication skills
    • Become Familiar with cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820
    • Become Familiar with FDA, ISO, DEA and OSHA regulations
    • Working knowledge of electronic document and ERP systems
    • Demonstration of the following:
      • Ability to manage multiple projects and work effectively in cross-functional teams with internal and external customer
      • Attention to detail and organization

    TECHNICAL EXPERTISE:

    • Deftly navigate through Quality and Warehouse Management Systems with training – MQ1, Tecsys Elite
    • Basic to Intermediate Microsoft Office skills: Outlook, Word, Excel, PowerPoint
    • Conversant with cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820
    • Basic comprehension of FDA and DEA regulations

    ADDITIONAL EMPLOYMENT REQUIREMENTS:

    • Must be able to successfully pass all preliminary employment requirements (ie, background check and drug screen)
    • Must have a valid driver's license

    PHYSICAL/MENTAL/VISUAL DEMANDS:

    • Work is light to medium in nature with frequent walking to perform assigned tasks.
    • Occasional lifting of up to 50 lbs. may occur.

    WORKING CONDITIONS:

    • Activities occur both inside (protected from weather conditions but not temperature changes) and outside
    • Employee is subjected to extreme cold while performing duties in the freezer
    • Hazardous conditions may exist, such as proximity to moving mechanical parts, electrical current, and working in high places

    EQUIPMENT OPERATED:

    • Equipment: Laptop computer, cell phone, fax machine, copier, and desk phone
    • Systems: Outlook, Excel, Word, PowerPoint, WebCTRL (Temperature Monitoring Software), TECSYS (Warehouse Management System), and MQ1 (Quality Management System)

    NO AGENCIES PLEASE

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