Quality Assurance

  • location: Northbrook, IL
  • type: Contract
  • salary: $30 - $33.78 per hour

job description

Quality Assurance

Job Title: Quality Systems Administration resource I

Position Responsibilities

  • Provides GMP Quality Assurance Support to Quality Technology (CTM and Commercial Readiness functions) by supporting the following activities:

    • Clinical Trial Material Documentation review including:

      • Review of Biologic Drug Substance Manufacturing Batch Records
      • Review of CTM Labeling Executed Batch records
      • Temperature Excursion Management
    • Document Management and support of CTM QP release via upload to the document repository for biologic CTM release
    • Management and review of Quality Agreements for CTM and Commercial Readiness functions
    • Document Management and archival to support First of Code programs managed by Commercial Readiness
Position Requirements

  • Required:

    • BA / BS in a science or engineering related field, with a minimum of 2 years of pharmaceutical or Medical Device industry experience in either CMC, GMP, Process Validation, QC and/or QA.
    • Knowledge of GMPs and other relevant regulations, as required, with a broad knowledge of quality principles and industry trends.
    • Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work across the Company groups and with external stakeholders.
    • Must be a self-starter, proactive and have the ability to manage department resources to achieve the desired outputs on a daily basis.
  • Preferred:

    • Direct experience in Biologics manufacturing (Drug Substance, Drug Product)
    • Experience using GxP Documentation systems (Such as ADMS or Documentum)
    • In-depth know of global industry standards and regulatory requirements (e.g., US, EU and Japan).
    • Direct experience in commercial readiness, CTM delivery, and / or QA.
    • Applied knowledge in the areas of Biologics, Solid Dose, Parenteral, Medical Device, and / or Regenerative medicines.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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