Quality Control Project Lead

Lonza•Houston, TX

3d•Onsite

About The Position

The Quality Control Project Lead leads the introduction of new methods and processes into the Quality Control department through technology transfer. The role provides technical support for investigations and represents QC on project teams. It supports method validation, ensures compliance with regulatory requirements, and contributes to QC testing for cell and gene therapy products. This is an on-site position in Pearland, Texas, with a Monday-through-Friday schedule from 8:00 a.m. to 5:00 p.m.

Requirements

Three to five years of experience in Quality Control.
Bachelor’s degree or higher in a scientific discipline.
Experience with method validation or qualification and technology transfer in a QC environment.
Strong understanding of cGMP principles and regulatory compliance.
Demonstrated ability to manage complex projects and prioritize tasks effectively.
Strong communication skills, including writing technical procedures and presenting project updates.
Proven ability to collaborate, lead teams, and build cross-functional relationships.
Proficiency with spreadsheets, databases, and word processing software.

Nice To Haves

Knowledge of biological and cell-based assays such as flow cytometry, ELISA, HPLC, ddPCR, and qPCR.
Familiarity with cell and gene therapy products.

Responsibilities

Lead technology transfer activities, including developing transfer plans, protocols, and reports.
Represent QC in project team meetings and communicate project status and timelines.
Review regulatory guidance and internal policies to ensure compliance with cGMP standards.
Write, review, and approve test records, sampling plans, specifications, and QC documentation.
Support stability programs and track testing progress and deliverables.
Collaborate with cross-functional teams, including QA, MSAT, and manufacturing.
Assist with deviations, OOS investigations, CAPAs, and audit responses.