QA Associate Quality Engineer

Alcon•Johns Creek, GA

1d•Onsite

About The Position

The Associate I, Quality Operations (Science/Tech/Engineering Path) works within Alcon’s Quality & Regulatory Affairs function, supporting quality management in manufacturing and distribution. The role handles complex tasks and contributes to advanced quality projects, monitors product quality, resolves non-conformances, and maintains documentation while applying scientific and engineering principles to solve problems and improve processes. The position serves as the lead Quality member of the Production Triage team, providing direction and support for non-conformance processes and product quarantine. It performs quarantine activities, including entering products into quarantine, completing documentation, reviewing and dispositioning non-conformance records for release, and removing products from quarantine areas. The role also audits manufacturing personnel and processes, analyzes audit results for trends, and communicates feedback to QA Operations management and the QA team. The associate works with Operations, Quality Engineering, Compliance, and Engineering personnel, participates in improvement work groups, and supports compliance with site Quality Systems and applicable regulatory requirements. The role requires adherence to GxP regulations and SOPs, accurate and complete documentation, quality control, required training, and a commitment to continuous improvement. This is an onsite, first-shift position in Johns Creek, Georgia. The schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m. EST. Travel, sponsorship, and relocation are not available.

Requirements

High school diploma or equivalent.
Fluency in reading, writing, understanding, and communicating in English.
Three years of relevant experience.
Ability to follow SOPs, maintain accurate documentation, ensure quality control, and complete 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 of the Production Triage team, providing direction and support for non-conformance processes and product quarantine.
Ensure non-conformance reports are initiated according to established requirements and that applicable activities are identified and implemented.
Perform product quarantine activities, including placing products in quarantine, completing quarantine documentation, reviewing and dispositioning non-conformance records for quarantine release, and removing products from quarantine areas.
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 documentation, ensure quality control, and complete required training.
Audit personnel and processes in manufacturing areas against 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.
Meet individual job requirements and contribute to organizational compliance and continuous improvement.
Work with Operations, Quality Engineering, Compliance, and Engineering personnel and participate in work groups to improve processes and product quality while complying with site Quality Systems procedures.