Quality Associate I - Filling (3rd shift)
On-site · Bloomington, Indiana, United States
Job Summary
The Quality Associate I is part of the Quality Assurance Line Operations Team, reporting to the Quality Line Operations Lead. It maintains quality oversight of manufacturing areas, performs checks during manufacturing processes, assesses regulatory and quality risks per regulatory rules and SOPs, and supports continuous improvement of processes. Responsibilities include compliance with worldwide regulatory requirements, in-process review of batch records and aseptic processing documentation, reporting errors and observations to management, quality functions in classified areas, collaboration for internal/external audits, initiating Nonconformance Reports and corrective/preventive actions (CAPAs), conducting bi-annual inspections of classified areas, SOP revisions to support continuous improvement, and ensuring SOPs are current with staff following them. Qualifications emphasize a Bachelor’s degree (preferred) or an Associate’s with experience, or no degree with relevant experience; proficiency in Word/Excel/Outlook and enterprise software (e.g., JDE, SAP, Maximo, TrackWise); PPE and Grade A/B gowning; overtime and physical requirements for manufacturing work; onsite Bloomington, IN role with Day One Benefits and comprehensive health, life, retirement, and other programs.
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.)
- Physical / Safety Requirements: 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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