Quality Associate I - Filling (weekend AM)
On-site · Bloomington, Indiana, United States
Job Summary
Quality Associate I joins the Quality Assurance Line Operations Team on-site at the Bloomington facility to oversee product quality in manufacturing, assess regulatory and quality risks per cGMP/GXP, and support continuous improvement. Responsibilities include in-process review of records for aseptic manufacturing, reporting errors/discrepancies, performing quality functions in classified areas, assisting with audits and CAPAs, initiating and authoring Nonconformance Reports and corrective/preventive actions, bi-annual inspections preparation, and ensuring SOPs are current and followed. The role requires collaboration with management, potential overtime and weekend shifts, and adherence to PPE and gowning requirements. Provides day-one benefits and a comprehensive benefits package.
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 the ability to use enterprise software (examples include: JDE, SAP, Maximo, TrackWise, etc.)
- Must wear appropriate PPE as required for various manufacturing areas
- Must be able to gown qualify for Grade A/B areas
- Duties will require overtime work, including scheduled weekend shifts
- Use of hands and fingers to manipulate office equipment is required
- Position requires standing for long hours, but may require sitting for periods of time
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