Quality Operations Specialist II – Onsite

Alcon; Georgia; On-site; USD 70,000 - 90,000; Full time

Job summary

Alcon in the United States is seeking an Associate II, Quality Operations (Professional Path) to manage complex quality processes, lead investigations, and drive CAPA initiatives across manufacturing and distribution.

You'll collaborate with Manufacturing, Quality, Engineering, and Regulatory Affairs to ensure compliant investigations, maintain GxP documentation, and support audits. A bachelor's degree or equivalent experience is required, and the role is onsite in Georgia.

Qualifications

• 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 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 appropriate methodologies such as 5 Whys, Fishbone Analysis, FMEA, and other problem-solving tools
• Develop, implement, and monitor corrective and preventive action (CAPA) plans to mitigate risk, prevent recurrence, 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 Good Practice (GxP) regulations and internal procedures
• Ensure adherence to Standard Operating Procedures (SOPs), training requirements, and applicable industry regulations
• Participate in internal and external audits, providing quality system support, CAPA documentation, and responses as required
• Analyze quality data and trends to identify opportunities for continuous improvement and enhanced process performance
• Conduct independent research and apply critical thinking to support quality initiatives and optimize business outcomes
• Meet individual performance expectations while contributing to organizational quality and compliance objectives

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 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 root cause analyses using 5 Whys, Fishbone Analysis, FMEA, and other problem-solving tools
• Develop, implement, and monitor CAPA plans to mitigate risk and improve performance
• Collaborate cross-functionally with Manufacturing, Quality, Engineering, and Regulatory Affairs to ensure CAPA implementation
• Communicate investigation status, findings, risks, and scope updates to leadership
• Prepare and present investigation reports, CAPA summaries, and documentation for reviews and inspections
• Maintain accurate quality records and documentation per GxP and internal procedures
• Ensure adherence to SOPs, training requirements, and applicable industry regulations
• Participate in internal and external audits, providing quality system support and CAPA documentation
• Analyze quality data and trends to identify opportunities for improvement
• Conduct independent research and apply critical thinking to support quality initiatives
• Meet performance expectations while contributing to quality and compliance objectives

Skills

Fluent English

Education

Bachelor's Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)

Job description

Alcon in the United States is seeking an Associate II, Quality Operations (Professional Path) to manage complex quality processes, lead investigations, and drive CAPA initiatives across manufacturing and distribution.

You'll collaborate with Manufacturing, Quality, Engineering, and Regulatory Affairs to ensure compliant investigations, maintain GxP documentation, and support audits. A bachelor's degree or equivalent experience is required, and the role is onsite in Georgia.