What are the responsibilities and job description for the Quality Control Analyst II, Raw Material 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 compendial testing from USP and Ph. Eur on incoming raw materials.
- Perform testing of raw materials, initial, in-process and final products. Parameters include appearance, pH, conductivity, and osmolality, Work under minimum supervision
- Perform incoming inspection of components used in the manufacturing process
- Perform sampling of materials to be tested in the raw materials laboratory
- Perform assays requiring precise analytical skills (i.e. Karl fisher, FTIR, UV Vis)
- Complete all testing, including special project / protocol testing in a timely and appropriate manner
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations
- Initiate deviations and laboratory investigations
- Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality
- Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs
- Perform equipment maintenance and calibrations as required
Qualifications
Working Conditions
Physical Requirements
