Supervisor, Stability

Company: Bausch + Lomb
Location: Columbus
Posted on: September 22, 2022

Job Description:

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.Position summary:The Stability Supervisor position is responsible for oversight of the stability team for stability studies conducted internally and externally managed studies. This person is our internal expert for stability study design relative to appropriate regulatory expectations and maintaining consistent quality practices. The person in this role will supervise staff to coordinate activities and resources associated with the annual stability program, annual product review, stability sections for regulatory filings, GEO Expansion activities, and investigations/CAPA activities. The team will be responsible for identification of relevant product trends with an emphasis on prevention and identification of future issues.Key responsibilities:This Quality position oversees stability team members and supports a pharmaceutical manufacturing environment through the application of various statistical tools to analyze data and generate reports to support product development, registration and modification and marketed product shelf life via annual product review process or planned changes. Work is performed in an office/laboratory and/or warehouse environment. This position oversees and/or performs in-depth evaluation and analysis of pharmaceutical stability data. This leader will be responsible for supervision of stability staff that manages the shelf-life and accelerated stability program, including writing accurate and error free study protocols, compiling interpreting data and approving summarized data in stability reports.Drive continuous improvement efforts for stability programsParticipate in audits of this functionProvide standard processes and expectations for stability programsParticipate in OOT/OOS investigations, tracking and trending, annual reports, and submissions to regulatory agencies, as required.Assure compliance to current GMP expectations for team members and programs.Responsible for the GxP, ISO, and EHS procedure awareness and compliance within the respective area.Support customer and regulatory audits as needed.Set, track, and share appropriate key metric data. Coordinate the evaluation of stability data to look for trends and help establish appropriate limits for product release, shelf-life, , alert, and action limits.Trending, analysis, and writing of technical and stability reports to support annual product review, regulatory filing for new/modified process and/or product investigations.Maintains filing system and document retention program.Qualifications and experience:Bachelors degree in science related field requiredExperience in Microsoft programs, document control systems, and lab data systems are preferred.5+ years working in biotech/pharmaceutical industry experience. Knowledge of cGMP (Pharmaceutical industry)Computer software skills (Word processing, database and spreadsheets).Ability to analyze and interpret analytical data.Excellent verbal and written communication skills.Ability to make effective and persuasive presentations.Strong analytical and problem-solving skills.High degree of initiative and self-motivation. Ability to work independently.This position may be available in the following location(s): [[location_obj]]All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.To learn more please readBausch+Lomb's Job Offer Fraud Statement (https://valeant.icims.com/icims2/servlet/icims2?module=AppInert&action=download&id=224770&hashed=-1624416981) .

Keywords: Bausch + Lomb, Columbus , Supervisor, Stability, Other , Columbus, Georgia