Job Description
Description
The laboratory employs a variety of test methodologies that use sophisticated equipment including: HPLC/UPLC capillary electrophoresis and general chemistry methodologies such as: Appearance Color Clarity pH Osmolality Polysorbate Protein Concentration and Sub-Visible Particle testing.
Responsibilities include the following:
- Follow safety guidelines cGMPs Good Manufacturing Practices and other applicable regulatory requirements
- Generate complete accurate and concise laboratory documentation using electronic systems and laboratory notebooks
- Ensures that facilities equipment materials organization processes procedures and products follow cGMP practices and other applicable regulations
- Operate laboratory equipment and instrumentation
- Performs review and approval of assays documents and records
- Supports Continual Improvement initiatives
- Alerts management of quality compliance supply an...