Manufacturing Specialist
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What you'll do
• Own and execute supplier-related change control quality records in TrackWise and SAP.
• Lead cross-functional meetings to keep change control records moving and closed on time.
• Assess supplier-related quality records with sound critical thinking and compliance judgment.
• Triage nonconformances, author investigation reports and drive CAPA execution and closure.
• Initiate, revise and approve procedures and support process monitoring and trending.
• Support process validation, new product introductions and regulatory inspections as needed.
• Bachelor's degree + 4 years (or Master's + 2, Associate's + 8, High School + 10, or a Doctorate) of manufacturing operations experience.
• Strong change control expertise, ideally with supplier-related quality records.
• Hands-on TrackWise and SAP experience.
• GMP biopharmaceutical manufacturing knowledge; nonconformance/CAPA and root cause experience.
• Able to lead cross-functional meetings and drive results with multiple stakeholders.
• Strong technical writing and communication; bilingual English/Spanish preferred.
• Contract: 5 months, with possible extension
• Shift: Administrative, Monday–Friday (40 hours/week)
• Start: Immediate
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