Associate II, Quality Operations

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

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly.

The Associate II, Quality Operations (Professional Path) is primarily responsible for managing complex quality processes, leading investigations, and contributing to advanced quality management initiatives.

Specifics Include:

• 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 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

WHAT YOU’LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related 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

HOW YOU CAN THRIVE AT ALCON:

• Collaborate with teammates to share standard processes and learnings as work evolves!
• See your career like never before with focused growth and development opportunities!
• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [e-mail] and let us know the nature of your request and your contact information.

At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.