Quality Associate I - Filling (2nd shift)
On-site · Bloomington, Indiana, United States
Job Summary
Quality Associate I is part of the Quality Assurance Line Operations Team and reports to the Quality Line Operations Lead. They maintain quality oversight during manufacturing by working with personnel, perform various checks, assess regulatory and quality risks per cGMP and company SOPs, and contribute to continuous improvement of processes. Responsibilities include in-process review of records for completeness and compliance, reporting errors and observations to management (with authority to stop operations if product safety is compromised), performing quality functions in classified areas, collaborating with management for audits, preparing CAPAs and Nonconformance Reports, conducting bi-annual area inspections, updating SOPs to support continuous improvement, and ensuring staff follow SOPs. This role requires 6:30am-3:30pm onsite at the Bloomington, IN facility, with potential overtime.
Required Qualifications
- Bachelor’s degree (preferred science discipline)
- Associate’s degree with at least 1 year of Pharmaceutical Quality, Pharmaceutical Manufacturing or other GXP regulated industry experience
- 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 PPE as required for various manufacturing areas
- Gown qualification for Grade A/B areas
- Overtime work, including scheduled weekend shifts
- Ability to stand for long hours and/or sit for periods of time
Desired Qualifications
- Bachelor’s degree (preferred science discipline)
- Associate’s degree with at least 1 year of Pharmaceutical Quality, Pharmaceutical Manufacturing or other GXP regulated industry experience
- 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.)
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