Quality Associate I - Filling (weekend PM)
On-site · Bloomington, Indiana, United States
Job Summary
Quality Associate I on the Quality Assurance Line Operations Team; maintains quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during manufacturing processes; assesses regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines; contributes to continuous improvement of processes; onsite at the Bloomington facility (6:30am-3:30pm) with weekend shifts; collaborates with management for internal/external audits; initiates Nonconformance Reports and CAPA responses; conducts bi-annual inspections of classified areas; ensures SOPs are current and staff perform tasks per SOPs.
Required Qualifications
- Bachelor’s degree (preferred science discipline) or Associate’s degree with at least 1 year of Pharmaceutical Quality, Pharmaceutical Manufacturing or other GXP regulated industry experience or no degree with at least 2 years Pharmaceutical Quality, Pharmaceutical Manufacturing or other GXP regulated industry experience
- Computer proficiency in Microsoft Word, Excel, and Outlook and ability to use enterprise software (examples include: JDE, SAP, Maximo, TrackWise, etc.)
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