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Quality Assurance Analyst I

Round Lake, ILRandstad LifeSciences

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Job Title:  Computer System Validation Quality

Position Description

  • Quality review / approval of computer validation documents to ensure compliance with company procedures and applicable regulatory requirements.

Position Responsibilities

  • Quality review and approval of computer validation documents for analytical instrument computerized systems to ensure the documents are accurate and compliant to; data integrity, computer system integrity, Baxter procedures and applicable regulations. This activity is focused on laboratory equipment utilized in the engineering, chemistry and information technology areas.
  • Work cooperatively with the system owner and the validation lead to obtain agreement of documents in case of missing requirements.
  • Review user manuals, standard operating procedures, validation documents, test plans, test scripts as needed.
  • Present information as needed to management in various areas of Baxter.
  • Approve system change control requests as needed.

Position Requirements

  • Bachelors degree (B.A./B.S.) or equivalent in science or related discipline.
  • 2-4 years related experience in a pharmaceutical, biotechnology and/or biomedical industry.
  • Working knowledge of computer validation requirements in government regulations including FDA 21 CFR parts 11, 58, 211, and 820, OECDs and related multinational industry standards and requirements.
  • 1-2 years experience in computer system validation, computer system validation auditing and/or quality assurance.’
  • Must have strong communication oral/written skills, ability to negotiate; and willing to participate in team activities.
  • Ability to work well with culturally diverse, multi-disciplined work groups, manage multiple priorities, and be self-directed in a fast-paced environment.
  • Ability to work with minimal supervision.
  • Excellent knowledge of Microsoft Word, Excel, Outlook, PowerPoint & SharePoint.
  • Good understanding of web based and database applications.
  • Strong organizational skills and attention to detail.
  • Team-oriented attitude.
  • Experience in writing and executing test plans/scripts.
  • Experience in validating, verifying and testing software.
  • Experience in a GMP and regulated environment


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance


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