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Quality Associate I – Supplier Quality Management

Quality Associate I – Supplier Quality Management

CompanySimtra BioPharma Solutions
LocationBloomington, IN, USA
Salary$Not Provided – $Not Provided
TypeFull-Time
DegreesBachelor’s, Associate’s
Experience LevelEntry Level/New Grad, Junior

Requirements

  • Bachelor’s degree (preferred science field), or Associate’s degree with at least three years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or high school diploma/GED with at least six years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience
  • Ability to understand cGMPs and other regulatory and international guidelines applicable to the life science industry
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, Trackwise, Veeva, etc.)
  • Data collection experience desirable

Responsibilities

  • Administrate the SQM documentation within the eQMS system and Simtra SQM SharePoint
  • Collaborate with Supplier Auditors in the Quality Agreement maintenance
  • Collect and analyze SQM system metrics
  • Collaborate on the creation of metric presentations for Management Meetings
  • Administrate the New Supplier process
  • Collaborate on the Supplier Review/Requalification process
  • Collaborate on the Supplier Change Notification process

Preferred Qualifications

  • Bachelor’s degree (preferred science field), or Associate’s degree with at least three years of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or high school diploma/GED with at least six years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience
  • Ability to understand cGMPs and other regulatory and international guidelines applicable to the life science industry
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, Trackwise, Veeva, etc.)
  • Data collection experience desirable