QC Analyst II

Lonza • Houston, TX

3d • Onsite

About The Position

The Quality Control Analyst II performs quality control assays for the release of cell therapy products, raw material release, and stability studies. The role maintains data and follows cGMP regulations, including writing deviations and other quality documentation. It requires demonstrated knowledge of biological and cell-based assays, including flow cytometry, and the ability to complete methods and procedures and operate specialized laboratory equipment. The analyst records test results and raw data accurately, makes sound decisions using defined SOPs and policies, and contributes to improving documentation and workflows. The role also supports colleagues through mentoring and training and is expected to develop subject matter expertise.

This is an on-site position in Pearland, Texas, scheduled Wednesday through Saturday from 6:00 AM to 4:30 PM to provide continuous quality control support. Weekend shift differentials are included. Compensation is hourly and determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

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.

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 extensive 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 to improve documentation and workflows.
• Maintain and troubleshoot basic and specialized laboratory equipment.
• Identify cGMP breaches and suggest corrective actions.
• Support the development of others through mentoring and training.

Benefits

• Performance-related bonus.
• Medical, dental, and vision insurance.
• 401(k) matching plan.
• Life insurance.
• Short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level