Associate II, Quality Operations

Alcon Research•Houston, TX

2d•Onsite

About The Position

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. Associate II, Quality Operations (Professional Path) is primarily responsible for handling complex tasks and contributing to advanced quality management projects. You will monitor product quality, resolve non-conformances, and maintain documentation while applying advanced quality management knowledge.

Requirements

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

Responsibilities

Handle complex tasks and contribute to advanced quality management projects within manufacturing and distribution processes
Make significant decisions within your project area to influence outcomes
Monitor product quality at different stages and resolve non-conformances promptly
Maintain relevant documentation and records
Conduct independent research and thought leadership activities to optimize outcomes
Ensure compliance with industry standards and regulations, adhering to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, and completing required training
Meet individual job requirements and contribute to overall organizational compliance
Lead and document CAPA investigations for non-conformances and deviations
Conduct thorough root cause analyses using appropriate methodologies (e.g., 5 Whys, Fishbone Analysis, FMEA, etc.)
Develop corrective and preventive action plans to mitigate risks and improve processes
Collaborate with cross-functional teams, including manufacturing, quality, engineering, and regulatory teams, to ensure thorough deviation investigation and CAPA effectiveness
Communication of status of investigation to leaders in organization, including update to deviation scope(s)
Prepare and present investigation reports and CAPA summaries to management and regulatory auditors
Participate in internal and external audits, providing CAPA-related documentation and responses as needed
Identify trends in quality issues and recommend continuous improvement initiatives