Sr. Associate, ESO Quality Assurance Compliance

Alcon Research•Fort Worth, TX

9d•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. The Sr. Associate, Quality Assurance Compliance (Professional Path) is primarily responsible for providing tactical site support to ensure compliance with site, Alcon, and international regulations at the Fort Worth ASPEX Manufacturing Facility. You will independently coordinate site gap assessments and apply advanced knowledge and skills to achieve objectives through self-directed work. This role is to support the external supply organization (ESO) for Alcon products produced by contract manufacturers. This role is part of Alcon's Quality Compliance Systems team for ASPEX which will primarily support CPDS and Product Change Control programs. This is not limited to these systems, however, will support all quality systems for the ASPEX manufacturing site.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
The ability to fluently read, write, understand, and communicate in English.
2 Years of Relevant Experience

Nice To Haves

Demonstrated experience conducting and/or supporting audit activities.
Experience with nonconformance investigations, CAPAs, and change requests.
Strong technical writing and documentation skills.
Proven ability to work effectively in cross-functional teams within a regulated environment

Responsibilities

Perform specialized tasks and conduct independent research to support the harmonization and standardization of the Quality Management System at Alcon, ensuring compliance with regulatory requirements.
Manage Quality Systems Management processes to ensure compliance with current Good Manufacturing Practices (cGMP), Health Authority, and Alcon Quality Manual requirements, as well as International Organization for Standardization (ISO) standards.
Facilitate the implementation of the Quality Strategy and support governance processes, identifying opportunities for improved process efficiencies and implementing changes.
Manage Quality Information Systems and Training programs to support a robust and sustainable quality management system.
Make significant decisions within the scope of assigned tasks, requiring advanced knowledge, analytical skills, and self-direction.
Adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.
Meet individual job requirements and contribute to the overall compliance of the organization, committing to continuous improvement and compliance with regulatory requirements.