Senior Operational Quality Assurance Specialist - 2nd Shift (1012)

FLSA Classification: Exempt/Salary 

Schedule: Monday – Friday; 1400 – 2230; On-Site (Eligible for one day of WFH per week after the successful completion of the 90-day probationary period).  

Department: Global Quality Operations 

Reports to: Operational Quality Assurance Manager 

Supervisory responsibilities: No 

Location: 13203 Murphy Road Suite 100 Stafford, TX 77477 

Position Summary/objective: 

The primary purpose of this position is to perform internal audits of manufacturing/CMC procedures; track and maintain standard operating procedures, work instructions, lab notebooks, manufacturing data and perform official batch and material release. 

Essential functions: 

• Oversee the batch release process for cell and gene therapy products, ensuring compliance with regulatory requirements, industry standards, and company policies. 

• Review and approve batch records, analytical data, and associated documentation to ensure accuracy, completeness, and compliance with relevant regulations and guidelines. 

• Conduct thorough quality checks on cell and gene therapy products, including verification of identity, potency, purity, and safety attributes. 

• Collaborate closely with cross-functional teams, including manufacturing, quality control, regulatory affairs, and clinical operations, to address any quality issues, deviations, or non-conformances during batch release. 

• Ensure appropriate corrective and preventive actions are implemented for identified quality issues and deviations. 

• Maintain and update batch release procedures, protocols, and documentation in accordance with current regulatory guidelines and industry best practices. 

• Provide guidance and support to junior members of the quality assurance team, including training, mentoring, and performance evaluation. 

• Participate in internal and external audits, inspections, and regulatory submissions, providing necessary documentation and information. 

• Contribute to the development and implementation of quality assurance strategies, policies, and procedures specific to cell and gene therapy products. 

• Identify opportunities for process improvements, risk mitigation, and increased efficiency in the batch release process. 

• Stay up to date with the latest advancements, regulations, and best practices in the field of cell and gene therapy manufacturing and quality assurance 

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 in a structured, reliable, and foresighted manner; combined with a high level of individual responsibility, enthusiasm, and strong social skills