Quality Operations Associate II: CAPA & Investigations

Alcon; Houston (TX); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Paid time off

Job summary

Alcon is seeking an Associate II, Quality Operations (Professional Path) to manage complex quality processes, lead investigations, and contribute to advanced quality initiatives across manufacturing and distribution. The role emphasizes CAPA development, root cause analysis, and cross-functional collaboration with Manufacturing, Quality, Engineering, and Regulatory Affairs.

The candidate will monitor product quality, resolve non-conformances, document investigations, and ensure GxP compliance.

Qualifications

• Bachelor's Degree or equivalent experience (or high school +8 yrs; Assoc.+4 yrs)
• The ability to fluently read, write, understand, and communicate in English
• Work Hours: Monday - Friday: 8:00 AM CST - 5:00 PM CST
• Travel Requirements: 0%
• Location: Onsite
• Sponsorship & Relocation: Not Available

Responsibilities

• Handle complex tasks and contribute to advanced quality management projects within manufacturing and distribution processes
• Make independent decisions within assigned project areas to drive quality outcomes and operational effectiveness
• Monitor product quality throughout various stages of manufacturing and distribution and ensure timely resolution of non-conformances
• Lead and document investigations related to deviations, non-conformances, and quality events in accordance with established procedures
• Conduct thorough root cause analyses utilizing 5 Whys, Fishbone Analysis, FMEA, and other problem-solving tools
• Develop, implement, and monitor CAPA plans to mitigate risk and improve process performance
• Collaborate cross-functionally with Manufacturing, Quality, Engineering, and Regulatory Affairs teams to ensure effective investigations and sustainable CAPA implementation
• Communicate investigation status, findings, risks, and scope updates to leadership and key stakeholders
• Prepare and present investigation reports, CAPA summaries, and supporting documentation for management reviews and regulatory inspections
• Maintain accurate quality records and documentation in compliance with GxP regulations and internal procedures
• Ensure adherence to SOPs, training requirements, and applicable industry regulations
• Participate in audits, providing quality system support, CAPA documentation, and responses
• Analyze quality data and trends to identify opportunities for continuous improvement
• Conduct independent research and apply critical thinking to support quality initiatives
• Meet individual performance expectations while contributing to organizational quality and compliance objectives

Skills

Root cause analysis

CAPA

Quality systems

Document control

Cross-functional collaboration

GxP knowledge

Audit support

Data analysis

English fluency

Education

Bachelor's Degree or equivalent

Job description

Alcon is seeking an Associate II, Quality Operations (Professional Path) to manage complex quality processes, lead investigations, and contribute to advanced quality initiatives across manufacturing and distribution. The role emphasizes CAPA development, root cause analysis, and cross-functional collaboration with Manufacturing, Quality, Engineering, and Regulatory Affairs.

The candidate will monitor product quality, resolve non-conformances, document investigations, and ensure GxP compliance.