QA Specialist - US

Randstad LifeSciences

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Job Title: QA Specialist - US

Job Responsibilities

  • Perform rapid response, walk thrus, process assessments, and change over walk-thrus 
  • Review executed solution batch records and executed BDS process batch records 
  • Review autoclave records and equipment alarms 
  • Review FAC alarms and cleaning verification forms 
  • Status label BDS
  • File QA documents and enter data in databases 
  • Review EMW data for facility and EM for bulk fills 
  • Review change over data 
  • Review supporting batch record documentation, as needed 
  • Attend cross functional meetings as OQ representative 
  • Perform self inspections and assist in internal audits and regulatory audits 
  • Partner in training sessions 
  • Performs other functions as necessary or as assigned. 
  • Can perform the MERP coordinator role. 

Education & Qualifications

  • Bachelor of Science 
    Area of Specialization* Science, Engineering or other Technical discipline

  • Minimum Level of Job-Related Experience required BS with 2+ years in a GMP environment  *Or combination of education and experience equivalent to

  • Good communication and interpersonal skills; Good organization skills; Attention to detail; Ability to work in a team environment; PC literate 


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


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