Sr. Associate, Quality Control Lab - Chemistry
Alcon Laboratories
Additional Job Description: At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? 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
- 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
- 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
- Imagine your career like never before with focused growth and development opportunities
- Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
- Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, and much more!
Vacancy posted 5 days ago
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