Operational Quality Assurance Specialist II - Second Shift

Immatics N.V.•Houston, TX

70d•Onsite

About The Position

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. 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.

Requirements

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.

Responsibilities

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

Benefits

Competitive rates for Health, Dental, and Vision Insurance
4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment.
Sick Time Off - 56 hours
12 Paid Holidays
100% Employer-Paid Life Insuranceâ¯up to at 1x annual salary, up to 100K (club together)
100% Employer Paid Short- and Long-Term Disability Coverage
401(k) with Immediate Eligibilityâ¯& company match…
You are eligible for 401(k) plan participation as of your first paycheck.
The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment.
Partially paid Parental Leaveâ¯for eligible employees. (3 weeks)
Additional voluntary employee paid coverage including Accident, Hospital Indemnity, and Critical Illnessâ¯Employee Paid Identity Theft Protection and Pet Insurance.
Opportunities to work with leading experts in the field of T-cell immunotherapy.
Company provided learning and development opportunities
Fast paced, high demand collaborative and dynamic environment.