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    Quality Assurance Specialist I - 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:

    • Reviews and approves Change Requests, Reactive Maintenance, Deviations/CAPA as assigned
    • Assist with validations as assigned
    • Review records and forms to ensure compliance with established LSL procedures and regulations
    • Maintain Quality files as applicable: Scan, Save to appropriate online storage, file
    • Perform warehouse walkthroughs to ensure the facility is maintained in a clean, safe, compliant manner
    • Be a part of the internal audit team and assist in external audits
    • Assist with the DEA program
    • Assist QA Supervisor and CQCU in developing plans and programs for process improvement
    • Interact with state and federal agencies, clients, and corporate quality group
    • Plan and present Quality System information to internal and external groups
    • Work with Quality Systems and all levels of facility personnel to achieve company quality standards
    • Perform Holds and Releases as directed by clients which can include temptale downloads as needed
    • Assist in the Returns, Damage and Recall processes
    • Review and approve inventory adjustments
    • Notify QA Supervisor and CQCU of any unusual trends
    • Perform training on Quality related documents when necessary
    • Other duties as assigned

    QUALIFICATIONS AND JOB SPECIFICATIONS:

    • Bachelor of Science (BS) degree in Engineering, Science, or related field preferred
    • Minimum of 1-3 years' experience in a quality role, preferably in a logistics setting
    • Conversant with cGMPs, Quality Systems, and CAPAs
    • Strong understanding of a 3PL business, audits and complaints procedures
    • Medical Device, Pharma and DEA experienced preferred
    • Knowledge of electronic document systems
    • Demonstration of the following:
    • Effective time management skills,
    • Impeccable verbal and written communication skills,
    • Ability to conduct appropriate research as needed,
    • Strong presentation skills,
    • Attention to detail and organization,
    • Critical thinking, and
    • Interest in working in a fast-paced environment

    TECHNICAL EXPERTISE:

    • Deftly navigate through Quality and Warehouse Management Systems with training – MQ1, Tecsys Elite, WebCTRL
    • Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint
    • Certified auditor training per ASQ or ISO (preferred)
    • Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA
    • Conversant with cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820
    • Verifiable aptitude of FDA, OSHA and DEA regulations
    • Intermediate public speaking and presentation skills
    • Excellent verbal and written communication skills

    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
    • Must be able to safely conduct occasional lifting of lbs
    • Ability to handle multiple priorities and solve inquiries and issues expeditiously and efficiently
    • Must be able to read at a distance, close to the eyes, and at arm's length with or without correction

    WORKING CONDITIONS

    • Activities occur within a typical office environment
    • 25% of time will be spent in a warehouse setting
    • 15 % of time will be spent on key entry

    EQUIPMENT OPERATED

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