QC Analyst II (PM Shift)

Lonza•Houston, TX
•Onsite

About The Position

The QC Analyst II performs Quality Control assays for the release of cell therapy products, raw material release, and stability studies. The role maintains accurate data and follows cGMP regulations, including writing deviations and other quality documentation. It requires knowledge of biological and cell-based assays, including flow cytometry, and the ability to complete procedures and operate specialized laboratory equipment. This is an on-site position in Pearland, Texas, scheduled Wednesday through Saturday from 4:00 PM to 2:30 AM. Shift differentials are included for nights and weekends. The position is hourly paid, with compensation determined by qualifications, skills, experience, and relevant knowledge. The analyst uses defined SOPs and policies to make sound decisions, records test results and raw data accurately, communicates information effectively, and offers suggestions to improve documentation and workflows. The role also supports colleagues through mentoring and training and is expected to be dependable and collaborative.

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.
  • 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 accurate records of test results and raw data.
  • Follow cGMP and cGDP principles and defined SOPs and policies.
  • Write deviations and other quality documentation.
  • Complete methods and procedures and operate specialized laboratory equipment.
  • Maintain and troubleshoot basic and specialized laboratory equipment.
  • Identify cGMP breaches and suggest corrective actions.
  • Present information and ideas effectively to help team members understand them.
  • Provide constructive suggestions for improving documentation and workflows.
  • Support the development of others through mentoring and training.
  • Contribute dependably and collaboratively in a team environment.

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).
  • Shift differentials for nights and weekends.
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