Role Overview

WeareseekingaSenior Operational Quality Assurance Specialistto support ourOperational Quality Assurance & Systemsteam.This roleis responsible forensuringquality and compliance across manufacturing and CMC activities by conducting internal audits and supporting batch and material release processes. You willmaintainand manage key documentation, including standard operating procedures, work instructions, lab records, and manufacturing data, while helping upholdhigh standardsin a regulated environment.

Schedule:30030; Monday to Friday

Reports to:Senior Operational QualityAssurance Manager

Location: 13203Murphy Road Suite 100 Stafford, TX 77477

Basic Qualifications:

• Bachelor27s degree in pharmaceutical sciences, life sciences, bioengineering, or a related field
• 4+ years of experience in quality assurance within biotechnology or pharmaceutical environments, including batch release activities
• 4+ years of experience working in regulated environments with cGMP and GCP standards
• Demonstrated experience reviewing batch records, analytical data, and technical documentation for product release
• Proven experience managing deviations, investigations, and CAPA processes

PreferredQualifications:

• Advanced degree (Master27sor higher) in pharmaceutical sciences, life sciences, bioengineering, or a related field
• Experience in cell and gene therapy or advanced therapeutics within a GMP-regulated environment
• Strong knowledge of global regulatory requirements (e.g., FDA, EMA, ICH) for biologics or advanced therapies
• Advanced ability to interpret complex manufacturing and analytical data to support quality decisions

In thisrole youwill:

• Oversee batch release activities for cell and gene therapy products, ensuring compliance with regulatory requirements and company standards
• Review and approve batch records, analytical data, and documentation for accuracy, completeness, and compliance
• Perform quality checks to verify product identity, potency, purity, and safety attributes
• Collaborate cross-functionally to resolve quality issues, deviations, and non-conformances
• Drive CAPA implementation and support continuous improvement of batch release processes
• Maintain and update procedures and documentation in line with regulatory guidelines and best practices
• Support audits, inspections, and regulatory submissions, and provide guidance to junior QA team members

What do we offer?

AtImmatics, we believe in investing in our team27s health,safetyand well-being.Here27swhat you can expectif youjoinImmatics

Comprehensive Benefits:

• Competitive rates forHealth, Dental, and Vision Insurance
• 4 weeks ofvacation,granted up front each year and prorated for firstand lastyear ofemployment.
• 12 company paid holidays
• 7daysof sick time
• 100%employer-paidlifeinsuranceup toat 1x annual salary, up to one hundred thousand dollars
• 100%employer-paidshort- andlong-Termdisabilitycoverage
• 401(k) withimmediateeligibilityandcompany match3% of your contributions upto3% of yourbase salaryfor the first two yearsof employment, 4% foryears 2-3 of employment, and up to5%of your salaryfrom the fourth year onward of continued employment.
• Partiallypaidparentalleavefor eligible employees.
• Additionalvoluntary employee-paidbenefits and services,includingaccident,hospitalindemnity, andcriticalillnessinsurance, as well as identitytheftprotection andpetinsurance.