QC Analyst II, Cell Therapy (PM Shift)

Lonza, Inc.•Houston, TX

40d•Onsite

About The Position

The purpose of this role is to perform Quality Control assays for product release of cell therapy products, Raw Material Release and Stability Studies. Maintain data and follow cGMP regulations including writing deviations and other Quality documentation. Skill set includes (but is not limited to) demonstrated knowledge biological, cell-based assays, including flow cytometry.

Requirements

Demonstrated knowledge in biological, cell-based assays, including flow cytometry required.
Demonstrated ability to complete methods/procedures and operate specialized lab equipment.
Perform tasks with strict adherence to cGMP and cGDP principles.
Capable of maintaining and troubleshooting basic and specialized lab equipment.
In-depth understanding of cGMP principles, with the ability to identify breaches and suggest corrective actions.
Developing Subject Matter Expertise, recognized as a reliable information source by less experienced analysts.
Proficient in using spreadsheets, databases, and word processing software.
Bachelor's degree in a relevant science field.

Responsibilities

Use extensive knowledge of defined SOPs & policies to make sound decisions.
Record test results and maintain raw data accurately.
Effectively present information and ideas, facilitating understanding among team members.
Provide constructive suggestions for improving documentation and workflows.
Dependable and excels in a collaborative team environment.
Support the development of others through mentoring and training.