Quality Control Associate

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...