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Quality Assurance Specialist II
Quality Assurance Specialist IILife Science Logistics LLC • Brownsburg, IN, US
Quality Assurance Specialist II

Quality Assurance Specialist II

Life Science Logistics LLC • Brownsburg, IN, US
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  • [job_card.full_time]
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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 25 - 50 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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