Sr. Associate, Quality Control Lab - Chemistry

Alcon Research•Fort Worth, AS

11d•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 Control Lab - Chemistry (Science/Tech/Engineering Path) is primarily responsible for designing, interpreting, and reporting stability studies for pharmaceutical and sterile products, ensuring compliance with Good Manufacturing Practice (GMP) and regulatory standards. You will provide expert stability advice, prepare and review protocols, and perform complex analyses in a lab-based role supporting Alcon’s commitment to product quality and patient safety. In this role, a typical day will include: This role is second shift M-F 2pm-10pm Perform specialized technical tasks and conduct research to optimize project outcomes within the quality control lab Design, execute, and interpret stability studies for pharmaceutical and sterile products in accordance with GMP and applicable regulatory requirements Prepare, review, and approve stability protocols, reports, and related documentation with a high level of accuracy and scientific rigor Conduct qualitative and quantitative chemical analyses, ensuring accuracy and precision to prevent production issues and support product release decisions Provide expert stability advice and technical guidance to cross-functional teams including Regulatory Affairs, Manufacturing, and R&D Ensure compliance with Standard Operating Procedures (SOPs) and GxP regulations by maintaining accurate, complete, and audit-ready documentation Investigate out-of-specification (OOS) results, laboratory deviations, and non-conformances, driving root cause analysis and corrective actions Complete all required training and maintain current knowledge of evolving regulatory guidelines and industry best practices Support a safe workplace by adhering to environmental, health, and safety standards within the laboratory environment.

Requirements

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

Nice To Haves

Experience with stability testing programs for pharmaceutical, ophthalmic, or sterile products
Hands-on knowledge of analytical techniques such as HPLC, UV-Vis spectroscopy, titration, and related methods
Familiarity with ICH stability guidelines (Q1A–Q1F) and FDA/EMA regulatory expectations
Strong scientific writing skills with experience preparing technical reports, protocols, and regulatory submissions
Ability to troubleshoot complex analytical problems and communicate findings clearly to both technical and non-technical stakeholders
Experience with laboratory information management systems (LIMS) or similar data management tools
2 years of relevant laboratory experience in a GMP-regulated environment

Responsibilities

Perform specialized technical tasks and conduct research to optimize project outcomes within the quality control lab
Design, execute, and interpret stability studies for pharmaceutical and sterile products in accordance with GMP and applicable regulatory requirements
Prepare, review, and approve stability protocols, reports, and related documentation with a high level of accuracy and scientific rigor
Conduct qualitative and quantitative chemical analyses, ensuring accuracy and precision to prevent production issues and support product release decisions
Provide expert stability advice and technical guidance to cross-functional teams including Regulatory Affairs, Manufacturing, and R&D
Ensure compliance with Standard Operating Procedures (SOPs) and GxP regulations by maintaining accurate, complete, and audit-ready documentation
Investigate out-of-specification (OOS) results, laboratory deviations, and non-conformances, driving root cause analysis and corrective actions
Complete all required training and maintain current knowledge of evolving regulatory guidelines and industry best practices
Support a safe workplace by adhering to environmental, health, and safety standards within the laboratory environment