Sr. Quality Associate II/ Principle Quality Associate
On-site · Clayton, North Carolina, United States
Job Summary
Lead/the primary point for quality objectives for the Alpha-1 product line, including production processes, clinical support, and all Quality aspects for the B300 Zone 2 business unit (CCRs, CAPAs, incidents). Interface with Manufacturing, Compliance, Regulatory, and other groups to support projects; prepare annual product quality reviews and quality reports for the EU; review/revise SOPs; support compliance initiatives and participate in inspections; contribute to multi-disciplined project teams addressing site/global quality issues; support clinical, stability, and engineering projects; manage site KPIs and quality management activities. Requires a BS/BA in STEM with 3+ years (Sr.) or 6+ years (Principle) of relevant experience; ability to work in an office/manufacturing environment; strong technical and communication skills; proficiency with quality systems and tools; familiarity with CAPAs, CCRs, SAP, and incident coordination. This role emphasizes leadership, mentorship, and SME-level expertise across multiple quality domains.
Required Qualifications
- BS/BA in STEM
- 3+ years relevant experience for Sr. Quality Associate II
- 6+ years relevant experience for Principle Quality Associate (or equivalent combination)
- Strong knowledge of cGMPs
- Experience with CAPAs, CCRs, incidents
- Ability to analyze data and prepare reports/presentations
- Effective communication skills (verbal and written)
- Ability to lead teams and work with cross-functional groups
- Proficiency in Excel, Word, PowerPoint
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