Associate II, Quality Operations

Alcon•Houston, TX

3d•Onsite

About The Position

The Associate II, Quality Operations (Professional Path) is part of Alcon’s Quality & Regulatory Affairs function and handles complex quality tasks while contributing to advanced quality management projects across manufacturing and distribution processes. The role monitors product quality, supports timely resolution of non-conformances, leads and documents investigations, and develops and monitors corrective and preventive action (CAPA) plans. It applies advanced quality management knowledge, conducts independent research, and uses critical thinking to support quality initiatives and operational effectiveness. The position collaborates with Manufacturing, Quality, Engineering, and Regulatory Affairs teams; communicates investigation status, findings, risks, and scope updates to leadership and stakeholders; and prepares reports and documentation for management reviews and regulatory inspections. It maintains accurate records in compliance with GxP regulations, internal procedures, SOPs, and training requirements, and supports internal and external audits. The role analyzes quality data and trends to identify continuous-improvement opportunities and contributes to organizational quality and compliance objectives. This is an onsite role with working hours of Monday through Friday, 8:00 AM to 5:00 PM CST, and no travel required. Alcon states that sponsorship and relocation are not available.

Requirements

Bachelor’s degree or equivalent years of directly related experience; alternatively, high school education plus 8 years or an associate degree plus 4 years.
Fluency in reading, writing, understanding, and communicating in English.

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 methodologies such as 5 Whys, Fishbone Analysis, FMEA, and other problem-solving tools.
Develop, implement, and monitor CAPA plans to mitigate risk, prevent recurrence, and improve process performance.
Collaborate with Manufacturing, Quality, Engineering, and Regulatory Affairs teams on 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 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.