What are the responsibilities and job description for the Quality Control Analyst II, Release & Stability Testing position at Rentschler?
Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.
We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies. Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!
Duties and Responsibilities
- Perform analytical testing using HPLC / UPLC / cGE / icIEF instruments following GMP documents
- Create / revise SOPs, Protocols and Reports
- Practice safe work habits and adhere to safety procedures and guidelines
- Perform maintenance and cleaning of laboratory equipment
- SME to support or lead activities related to OOS / OOT investigations, deviations, change controls, corrective actions, and preventive actions to correct and eliminate the potential for non-conformances
- Update and track metrics for trending and reporting; stability and QC analytical data
- Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
- Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems
- Exceptional communication and interpersonal skills
- Assists in training of new hires and retraining of QC laboratory staff, as needed
- Performs other duties as assigned
Qualifications
Working Conditions
Physical Requirements
