Operational Quality Assurance Specialist II

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Join to apply for the Operational Quality Assurance Specialist II role at Immatics

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

Immatics is at the forefront of immunotherapy innovation, working to harness the power of T cells to transform cancer treatment.

Immatics is an exceptional clinical-stage biopharmaceutical company active in the discovery and development of T cells redirecting cancer immunotherapies. We use these powerful T cells to develop groundbreaking immunotherapies that target cancer cells. We are dedicated to transforming cancer treatment and improving patient outcomes through cutting-edge research and advanced TCR technology.

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: 0800 – 1630;
Monday to Friday;
On-site

Reports to:
Senior Manager, Operational Quality Assurance

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

Required Experience and Education:

• Bachelor’s Degree in a Life Science Discipline is required.
• 2-3 years 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.
• 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 in a structured, reliable, and foresighted manner; combined with a high level of individual responsibility, enthusiasm, and strong social skills
• Ability to effectively collaborate with members from other departments

This is a sedentary position (at least 50%…