ABOUT VGXI INC.

VGXI is a leading-edge CDMO dedicated to revolutionizing the biopharmaceutical industry with best-in-class nucleic acid-based products and services. We deliver manufacturing excellence in state-of-the-art facilities with the agility and scale to meet projects of all sizes to serve the global community of next-generation therapeutic developers.
If you are driven by innovation, fueled by scientific curiosity, and committed to making a positive impact on the global pharmaceutical community, you’ve come to the right place. We are always looking for quality-minded, team-oriented individuals who share our dedication to excellence. At VGXI, we’ve cultivated a workplace that people genuinely enjoy being a part of, and we take immense pride in the role they play in shaping our success story. We embrace a culture of quality in our products and in our people. Explore the possibilities, unlock your potential, and contribute to the future of Plasmid DNA manufacturing and precision medicine with VGXI.

SUMMARY

The Quality Assurance Technical Specialist is responsible for supporting and maintaining the organization’s quality systems to ensure compliance with regulatory requirements and internal standards. This role focuses on activities such as validation documentation, protocol review, tech transfer support, and continuous improvement of quality processes. It does not include responsibilities related to product release or batch disposition.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Review and approve validation protocols, executed validations, and associated documentation (e.g., IQ/OQ/PQ, PPQ).
• Support tech transfer activities by ensuring quality system alignment and documentation compliance.
• Maintain and improve quality system elements such as CAPA, change control, document control, and training.
• Participate in and perform internal audits and support external regulatory inspections.
• Collaborate with cross-functional teams (e.g., Manufacturing, Engineering, R&D) to ensure quality system requirements are met.
• Track and trend quality metrics to identify areas for improvement.
• Ensure timely and accurate documentation within the electronic quality management system (eQMS).
• Provide guidance and training on quality system procedures and best practices.
• Responsible for proper documentation of equipment.
• Assist in development of quality system SOPs.
• Follow Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs).
• Work with other departments to solve customer/product issues as necessary.
• Interpret technical documentation and provide quality-focused feedback.
• Other QA duties as assigned or determined by Area Management

EDUCATION, EXPERIENCE, and PREFERRED SKILLS

• Bachelor’s degree in a scientific, engineering, or related field.
• 3+ years of experience in Quality Assurance or Quality Systems in a regulated industry (e.g., pharma, biotech, medical devices).
• Strong understanding of validation principles, quality systems, and regulatory requirements (e.g., FDA, ICH, ISO).
• Experience with electronic quality management systems (eQMS) preferred.
• Experience supporting tech transfer and validation lifecycle documentation, preferred.
• Familiarity with GMP environments and risk-based quality approaches, preferred.
• Excellent attention to detail, organizational, and communication skills.

• Review and approve validation protocols, executed validations, and associated documentation (e.g., IQ/OQ/PQ, PPQ).
• Support tech transfer activities by ensuring quality system alignment and documentation compliance.
• Maintain and improve quality system elements such as CAPA, change control, document control, and training.
• Participate in and perform internal audits and support external regulatory inspections.
• Collaborate with cross-functional teams (e.g., Manufacturing, Engineering, R&D) to ensure quality system requirements are met.
• Track and trend quality metrics to identify areas for improvement.
• Ensure timely and accurate documentation within the electronic quality management system (eQMS).
• Provide guidance and training on quality system procedures and best practices.
• Responsible for proper documentation of equipment.
• Assist in development of quality system SOPs.
• Follow Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs).
• Work with other departments to solve customer/product issues as necessary.
• Interpret technical documentation and provide quality-focused feedback.
• Other QA duties as assigned or determined by Area Managemen