Quality Associate I – Supplier Quality Management
Company | Simtra BioPharma Solutions |
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Location | Bloomington, IN, USA |
Salary | $Not Provided – $Not Provided |
Type | Full-Time |
Degrees | Bachelor’s, Associate’s |
Experience Level | Entry 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