QC Analyst II (PM Shift)

Lonza•Houston, TX

2d•Onsite

About The Position

The Quality Control Analyst II performs Quality Control assays to support release of cell therapy products, raw material release, and stability studies. The role maintains accurate data and follows cGMP regulations, including preparing deviations and other quality documentation. The position is on-site in Pearland, Texas, and works Wednesday through Saturday from 4:00 PM to 2:30 AM, providing continuous quality control support. Night and weekend shift differentials are included. The analyst uses established SOPs and policies to make sound decisions, accurately records test results and raw data, and communicates information effectively to team members. The position also contributes suggestions to improve documentation and workflows, collaborates with the team, and supports colleagues through mentoring and training. The role requires knowledge of biological, cell-based assays, including flow cytometry, and the ability to operate and troubleshoot laboratory equipment while adhering strictly to cGMP and cGDP principles.

Requirements

Demonstrated knowledge of biological, cell-based assays, including flow cytometry.
Demonstrated ability to complete methods and procedures and operate specialized laboratory equipment.
Strict adherence to cGMP and cGDP principles.
Ability to maintain and troubleshoot basic and specialized laboratory equipment.
In-depth understanding of cGMP principles, including the ability to identify breaches and suggest corrective actions.
Proficient use of spreadsheets, databases, and word processing software.
Bachelor's degree in a relevant science field.

Responsibilities

Perform Quality Control assays for cell therapy product release, raw material release, and stability studies.
Maintain data and follow cGMP regulations, including writing deviations and other quality documentation.
Use knowledge of defined SOPs and policies to make sound decisions.
Record test results and maintain raw data accurately.
Present information and ideas effectively to support understanding among team members.
Provide constructive suggestions for improving documentation and workflows.
Collaborate dependably in a team environment.
Support the development of others through mentoring and training.
Complete methods and procedures and operate specialized laboratory equipment.
Maintain and troubleshoot basic and specialized laboratory equipment.
Identify cGMP breaches and suggest corrective actions.