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.
Objectives/Purpose of Job:
Work is performed in an office/ laboratory and/or warehouse environment. This position performs in-depth evaluation and analysis of pharmaceutical products stability data. Person will be responsible for managing the shelf-life and accelerated stability program, including writing accurate and error free study protocols, compiling and interpreting data and summarizing data in stability reports (Annual Product Review etc).
This Quality position supports a pharmaceutical manufacturing environment through the application of various statistical procedures, methods, and tools and will analyze data and generate reports to support product development, registration and modification to filing and marketed product and marketed product shelf life via annual product review process.
• Processing of incoming test samples into the stability database (data entry/ review/ verification/approval).
• Coordinate and perform functions related to and including: creation of stability studies and stability batch records, ensuring/verifying placement of lots on stability and updating stability database, tracking of stability lots.
• Data entry, trending, analysis, and writing of technical and stability reports to support annual product review, regulatory filing for new/modified process and/or product investigations.
• Reviews and evaluates stability data. Identifies, analyses, reports and confirms out of trend or out of specifications results to the Department Supervisor / QC lab (chemistry and or micro).
• Collects and analyzes pharmaceutical drug product stability data via appropriate statistical methods.
• Looks for variation trends and helps to establish appropriate control, alert, and action limits.
• Evaluate product degradation trends and confidence limits on annual bases and prepare stability Annual Product Review reports per the established schedule for internal and external customers.
• Prepares written documentation, including protocols and reports, to support product shelf-life claims. Prepare charts, graphs, or forms to go along with the reports.
• Identifies improvements for current procedures and practices and revises documentation accordingly. Responsible revisions of department documentation, creation and closure of CR and QCR's.
• Supports and/or conduct NC investigations.
• Maintains filing system and document retention program.
• Maintenance of quality systems and cGMP compliance for the business by ensuring compliance with processes, procedures and instructions for all activities.
• QC laboratory support on as needed basis (trend report preparation). All other duties as required and assigned.
College or Bachelor's degree required.
5+ years in Pharmaceuticals or related industry.
5 years working in biotech/pharmaceutical Industry experience.
Demonstrated ability to apply statistical tools and models to help solve product performance variability issues.
Use of Statistical programming, Statistical Modeling, and Statistical Tools (i.e. ScienTek, MiniTab, and Excel) is required. Experience in Microsoft programs, inventory management systems, document control systems, and lab data systems are preferred.
Computer software skills (Word processing, database and spreadsheets). Adequate typing skills.
Ability to read, 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.
Demonstrated ability to identify and adapt to shifting priorities and competing demands.
Strong attention to detail and accuracy.
Strong time management and prioritization skills for management of multiple projects.
Strong organization skills.
Organizational savvy, ability to navigate/ network within a large organization. Ability to establish and maintain effective working relationships with others.
Diplomacy, negotiation skills, written and oral communication, independent work skills, strong work ethic.
Knowledge of cGMP (Pharmaceutical industry) is a plus (Training will be provided).
Expertise in statistical principles, methods, and procedures and the ability to instruct others in these areas.
Knowledge of statistical sampling practices.
Previous experience in application of statistical models to predict product long term stability.
Must be able to read, write, and speak English and possess basic math skills.
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.
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