QC Analyst II

Lonza•Houston, TX

2d•Onsite

About The Position

The Quality Control Analyst II performs Quality Control assays supporting the release of cell therapy products and raw materials, as well as stability studies. The role maintains accurate data and complies with cGMP regulations, including writing deviations and other quality documentation. The position requires knowledge of biological, cell-based assays, including flow cytometry, and the ability to complete methods and procedures using specialized laboratory equipment. This is an on-site position in Pearland, Texas, working Wednesday through Saturday from 6:00 AM to 4:30 PM. Weekend shift differentials are included. The position is hourly paid, with compensation determined by the candidate’s qualifications, skills, experience, and relevant knowledge. Lonza describes its globally connected teams as working across more than 30 sites on five continents. Its stated core values are Collaboration, Accountability, Excellence, Passion, and Integrity. The company also states its commitment to equal employment opportunities for qualified applicants.

Requirements

Demonstrated knowledge of biological, cell-based assays, including flow cytometry.
Demonstrated ability to complete methods and procedures and operate specialized laboratory equipment.
Perform tasks with 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.
Proficiency with spreadsheets, databases, and word processing software.
Bachelor’s degree in a relevant science field.

Nice To Haves

Developing Subject Matter Expertise, with recognition as a reliable information source by less experienced analysts.
Dependable and effective in a collaborative team environment.
Ability to present information clearly and offer constructive workflow and documentation improvements.

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 facilitate understanding among team members.
Provide constructive suggestions for improving documentation and workflows.
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.