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Internal / Quality Assurance Auditor

Internal / Quality Assurance Auditor

LifeScience LogisticsCoppell, TX, United States
22 hours ago
Job type
  • Full-time
Job description

Responsibilities

  • Develop and lead the internal audit plan, which will include on-site and virtual audits of LSL facilities with the support of the audit team
  • Develop internal reporting plan for audit results and observations including metrics for internal management reviews
  • Administrator for the internal audit program within LSL's eQMS
  • Develop, train and internally certify new employees to participate in the internal audit program
  • Lead internal meetings regarding audit observations and remediation plans
  • Other duties as assigned by supervisor

Qualifications and Job Specifications

  • 4-year degree highly preferred, such as Bachelors of Science (B.S.)
  • 3-5 years' experience in pharmaceutical and / or medical device industries preferred
  • 3-5 years' audit experience in an internal or external audit capacity
  • ASQ and or ISO Auditor Certifications required

    • Technical Expertise

  • Deftly navigate through Quality and Warehouse Management Systems with training (ComplianceQuest and Tecsys Elite WMS)
  • Intermediate Microsoft Office skills : Outlook, Excel, PowerPoint, Adobe Acrobat
  • Conversant with cGMPs / cGDPs, Quality Systems, DEA (Preferred)
  • Intermediate Technical Writing skills
  • Verifiable aptitude of temperature-controlled warehousing

    • Additional Employment Requirements

  • Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen)
  • Must have a valid Drivers License
  • Travel is required for in-person audits

    • Physical / Mental / Visual Demands

  • Work is light to medium in nature
  • Must be able to read at a distance, close to the eyes, and at arm's length, with or without correction
  • Ability to handle multiple priorities expeditiously and efficiently

    • Working Conditions

  • Activities occur both inside and outside.
  • Hazardous conditions may exist, such as proximity to moving mechanical parts.

    • Equipment Operated

  • Equipment : Laptop Computer, Cell Phone, Copier
  • Systems : Outlook, Excel, Word, PowerPoint, and MQ1 and Compliance Quest (Quality Management Software)

    • Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

    The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)