QA Associate Quality Engineer

Alcon Research•Johns Creek, GA

1d•Onsite

About The Position

This role is part of Alcon’s Quality & Regulatory Affairs function, which ensures products comply with global, local, and internal regulations and meet quality standards. The Associate I, Quality Operations (Science/Tech/Engineering Path) handles complex tasks and contributes to advanced quality management projects in manufacturing and distribution. The role monitors product quality, resolves non-conformances, maintains documentation, and applies scientific and engineering principles to solve problems and innovate. The position serves as the lead Quality member on the Production Triage team, providing direction and support for the non-conformance process and product quarantine. It includes initiating non-conformance reports, identifying and implementing applicable activities, and performing product quarantine tasks, including quarantine entry, documentation, review and disposition of non-conformance records for release, and product removal from the quarantine area. The associate follows GxP regulations and Standard Operating Procedures (SOPs), maintains accurate documentation, ensures quality control, and completes required training. The role also audits personnel and processes in manufacturing areas against procedures and regulatory requirements, analyzes audit results for trends, and provides feedback to QA Operations management and the QA team. The associate collaborates with Operations, Quality Engineering, Compliance, and Engineering personnel, participates in work groups, and contributes to continuous improvement and organizational compliance. This is an onsite, first-shift position in Johns Creek, Georgia, scheduled Monday through Friday from 8:00 AM to 5:00 PM EST. Travel and sponsorship or relocation are not available.

Requirements

High school diploma or equivalent.
Ability to fluently read, write, understand, and communicate in English.
Three years of relevant experience.
Compliance with GxP regulations, SOPs, documentation, quality control, and required training.

Nice To Haves

Bachelor’s degree preferred.

Responsibilities

Handle complex tasks and contribute to advanced quality management projects.
Make significant decisions within the assigned project area to influence outcomes.
Monitor product quality at various stages and promptly resolve non-conformances.
Maintain relevant documentation and records.
Apply scientific and engineering principles to solve problems and innovate.
Participate as the lead Quality member on the Production Triage team, providing direction and support for the non-conformance process and product quarantine.
Ensure non-conformance reports are initiated according to established requirements and applicable activities are identified and implemented.
Perform product quarantine activities, including entering product into quarantine, completing documentation, reviewing and dispositioning non-conformance records for quarantine release, and removing product from the quarantine area.
Stay current with advances in the field and use an agile approach to problem-solving by testing, iterating, and refining solutions.
Follow GxP regulations and SOPs, maintain accurate and complete documentation, ensure quality control, and complete required training.
Audit personnel and processes in manufacturing areas against practices, procedures, and current regulatory requirements, including FDA and ISO requirements.
Analyze audit results for trends and provide feedback to QA Operations management and the QA team.
Collaborate with Operations, Quality Engineering, Compliance, and Engineering personnel and participate in work groups to improve processes and product quality while maintaining compliance with site Quality Systems procedures.
Meet individual job requirements and contribute to organizational compliance and continuous improvement.