Quality Assurance Specialist

2 months ago

Atlanta, United States Life Science Logistics LLC Full time
Job DescriptionJob 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 template 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 – CQ, 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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