Operational Quality Assurance Specialist II - Second Shift

Join Immatics and shape the future of cancer immunotherapy; one patient at a time!  

Immatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics. 

Why Join Us? 

• Innovative Environment: Help to pioneer advancements in cancer immunotherapy. 

• Collaborative Culture: Be part of a diverse team dedicated to your professional growth. 

• Global Impact: Contribute to therapies that make a lasting impact on patients globally. 

We are seeking an Operational Quality Assurance Specialist II to join our Operational Quality Assurance team. In this role, the specialist will be responsible for conducting internal audits of manufacturing and CMC (Chemistry, Manufacturing, and Controls) procedures, ensuring compliance with regulatory and company standards. The position also involves tracking and maintaining critical documentation such as standard operating procedures, work instructions, lab notebooks, and manufacturing data. Additionally, the specialist will oversee and execute official batch and material release activities, supporting overall quality assurance operations. 

FLSA Classification: Hourly, Non-Exempt  

Schedule: 1230 – 2100; Monday to Friday; On-site  

This is a critical position and may require working overtime, after-hours, weekends, or holidays to ensure business continuity.

Reports to: Operational Quality Assurance Associate Manager - 2nd Shift 

Location: 13203 Murphy Road Suite 100 Stafford, TX 77477  

What You’ll Do: 

As an Operational Quality Assurance Specialist II, you will play a key role in supporting our batch and material release:  

• Maintaining equipment logs and files 

• Tracking manufacturing numbers 

• Performing internal audits of the manufacturing process 

• Writing audit reports 

• Creating and performing internal Quality Assurance trainings for Immatics personnel 

• Writing new standard operating procedures and batch records 

• Keeping track of lab notebooks 

• Providing support for the investigation and recall of non-conforming materials 

• Writing, reviewing, and tracking deviation reports, corrective and preventive actions (CAPA) reports, maintenance reports and Out of Specification (OOS) reports  

• Issuance and reconciliation of final product labels 

• Certificate of Analysis (CoA) review and release for completed batches 

• Review of sterility, endotoxin, and mycoplasma results 

• Reagent review and release  

• Initiation and completion of Change Controls for all updates to processes or documents 

• Maintains electronic log of all US equipment 

 Secondary Functions:  

N/A 

Required Experience and Education: 

• Bachelor’s Degree in a Life Science Discipline is required.  

• 3+ years of experience in QA, Auditing, or clinical manufacturing in a research environment. 

• At least 3-5 years of Biotechnology and/or Pharmaceutical industry experience is required. 

• Experience comprehending regulations and guidance documents. 

Preferred Experience and Education:  

N/A 

Competencies:  

• Ability to make sound decisions and approach problems with curiosity and open-mindedness  

• High degree of independent working, analytical reasoning, and the ability to communicate effectively 

• Careful editing and documenting of results 

• Ability to embrace rapidly changing requirements with an open mind and show a high degree of flexibility in an environment which is marked by a constant striving for excellence 

• Ability to approach tasks