Über die Tätigkeit
Role and Responsibilities:
- Review of paperwork for compliance and sampling of raw materials
- Detailed analysis on diverse materials, issuing reports and communicating results
- Perform analytical chemistry work including but not limited to: HPLC/UPLC, Infrared, UV/Vis, Color/wet chemistry, pH, titrations, Karl Fisher, Loss on drying
- General lab duties as pertaining to safety and cleanliness
- Project work that may be on-going or have a specified time frame
- Perform advanced chemical analysis and investigations for high risk or out of specification products, including Corrective and Preventative Actions and follow-ups
- Perform install/operational/performance qualifications and validations
- Maintain samples and order as needed reagents, lab supplies and reference materials
- Review Quality documentation for completeness and compliance, forward as required
- Participate in continuous improvement of the Quality department and site as a whole; record keeping, lab processes, site safety, etc.
Ihr Profil
Profile/Experience:
- A bachelor’s degree in a science field and 4-6 years in pharmaceutical quality control or combination of QC and other pharmaceutical quality experience. (graduate school may be considered toward experience)
- Working knowledge of Current Good Manufacturing Practices and appropriate sections of CFR 210 and 211
- Basic typing, computer and office skills
- Knowledge of cGMP/GLP/GDP, USP, FDA regulatory requirements
- Experience performing HPLC/UPLC testing using industry best practices
- Excellent interpersonal communication and organizational skills
- Qualified to work with controlled substances
- Knowledge and experience performing serial dilutions
- Experience Handling Biohazardous materials
- Knowledge of analytical support activities for production support and validations
- Ability to conduct OOS investigations with lab management and other functional areas
- Ability to perform method development activities independently
- Ability to establish priorities, work independently and proceed with objectives without supervision
- Ability to manage project work while managing daily duties and completing all on time
- Ability to adapt to new or updated processes
Unser Angebot
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.