Sr. QA Investigations Specialist

FLSA Classification: Exempt/Salary  

Schedule: Monday to Friday; 8:00am to 5:00pm; On-site 

Department: Global Quality Operations  

Reports to: Operational Quality Assurance Manager  

Supervisory responsibilities: No 

Location: 13202 Murphy Road Suite 100 Stafford, TX 77477 

Position Summary/objective: 

The Sr. Quality Assurance Investigation Specialist is responsible for overseeing the batch release process for cell and gene therapy products, ensuring compliance with regulatory requirements, industry standards, and company policies. This role involves independently authoring and resolving deviations, driving process improvements, and managing complex deviation investigations. The ideal candidate will effectively communicate across multiple groups and levels to drive deviation closure and support the overall quality assurance strategy. 
 

Essential functions: 

• Independently author/Review Deviations in order to meet Batch release requirements for cell and gene therapy product. 

•  Focus on deviation closeout and providing resolution by ensuring timely identification, investigation, and closure of deviations, including root cause analysis and implementation of effective corrective and preventive actions (CAPA). 

• 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. 

• Communicate across multiple groups and levels to drive deviation closure and provide regular progress updates. 

• Identify interdepartmental process improvements and work cross-functionally to implement them. 

• Utilize advanced root cause analysis techniques and technical impact analyses during the deviation investigation process. 

• Manage multiple priorities either independently or as part of a team in order to meet key deadlines and communicate issues and progress across all levels of the organization. 

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

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

• Participate in the training process and coaching of new team members and processes. 

• Assist with metric reporting and workload management to meet the team’s priorities. 

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