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Quality Analyst I

Round Lake, ILRandstad LifeSciences

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Job Title:  Quality Analyst I

Position Description

  • Conducts reviews of documentation and reports for conformance to procedures, protocols and regulatory requirements within the recall department. This is important FDA mandated work so they need candidates that are professional with strong attention to detail and are organized.

Position Responsibilities

  • Responsible for reviewing pertinent documents, records and reports such a Manufacturing Formulation Records (MFRs), Manufacturing batch Records (MBRs), etc. against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
  • Identify areas of non-conformance and inform management via the drafting of Non-Conformance Reports (NCRs) as needed to be disposed (unilaterally accepted or rejected) by others.
  • NCRs at this level are minor and involve no patient risk.
  • Administer and maintain relevant databases, preparing and issuing reports as defined by the area.
  • Assist in external and internal audits by maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc.
  • Doing status reports for our reportable events
  • Helping chase documents for upfront processing
  • Reviewing documents that are compiled for the issues that come in the process that tell what the issue is and how it happened
  • Helping the team with execution activities like reviewing customer lists
  • Helping with pulling data for regulatory reports
  • Helping reconcile holds for FA closures

Position Requirements

  • Associate degree in scientific discipline and one to three years of relevant experience.
  • Bachelor's degree in the life sciences and experience with a medical device/pharma or other similarly regulated industry preferred.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
  • Strong interpersonal skills and great attention to detail are necessary.
  • Must be a strong team player with good problem solving, detailed oriented and good verbal and written communication skills.
  • Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.


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


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