Quality Assurance Specialist

Quality Assurance Specialist

The mission of Pack Gene Biotech is to accelerate gene therapy product development by providing an integrated one-stop shop solution to the gene therapy industry. We strive to make gene therapy accessible to more patients in needs. Gene therapy is believed to revolutionize the healthcare field in upcoming years. Pack Gene is well positioned to play a big role in this transformation.

Pack Gene Biotech was founded in 2014 and headquartered in Guangzhou, China. It is a leading gene therapy CRO/CDMO service provider in Asia and USA.

The QA Specialist will support manufacturing operations for our customers at the new cGMP facility in Houston TX designed to manufacture clinical stage gene therapies.

Key responsibilities include:

• Review and approve Quality System records, including deviations, change controls, CAPAs, investigations, risk assessments, and other quality records, ensuring appropriate root cause analysis, impact assessment, corrective actions, and timely closure.
• Develop, review, and approve GMP documentation, including SOPs, manufacturing records, forms, protocols, reports, specifications, and other controlled documents, as assigned.
• Review executed batch records and associated GMP documentation for completeness, accuracy, compliance, and adherence to approved procedures and applicable regulatory requirements.
• Perform QA-on-the-floor activities to provide real-time Quality oversight of manufacturing operations, including observation of critical operations, review of documentation, assessment of GMP practices, and resolution or escalation of quality issues.
• Provide Quality oversight of aseptic processing and other critical GMP operations, as applicable, ensuring compliance with established procedures, contamination control requirements, and applicable regulatory expectations.
• Support material disposition/release activities, including review of applicable documentation and confirmation that established Quality requirements have been met.
• Serve as a primary Quality Assurance point of contact for manufacturing operations, providing timely, independent, and risk-based Quality guidance and decisions within the individual's assigned authority. Escalate significant quality or compliance risks to Quality leadership as appropriate.
• Lead or actively participate in Quality review boards and cross-functional discussions related to deviations, CAPAs, change controls, investigations, batch disposition, and other quality matters.
• Provide guidance to cross-functional teams during deviation investigations, including event assessment, product and process impact evaluation, root cause analysis, CAPA development, and determination of appropriate Quality actions.
• Assess quality events and proposed changes for potential impact to product quality, patient safety, validated state, regulatory commitments, and GMP compliance.
• Communicate and collaborate directly with customers regarding quality events, investigations, changes, documentation, batch disposition activities, and other Quality matters impacting their programs, ensuring timely and professional communication.
• Lead and coordinate batch record review and batch disposition activities, ensuring all required manufacturing documentation, testing, deviations, investigations, and other applicable Quality requirements are satisfactorily completed prior to final disposition by the authorized Quality representative.
• Support review and approval of manufacturing-related protocols and reports, including validation, qualification, media fill/aseptic process simulation, and other GMP studies, as assigned.
• Participate in internal audits, client audits, and regulatory inspections, including preparation activities, document review, SME support, observation response, and follow-up actions, as assigned.
• Monitor quality trends and metrics and identify recurring issues, compliance risks, and opportunities for continuous improvement.
• Provide coaching and guidance to Manufacturing and other cross-functional personnel regarding cGMP requirements, good documentation practices, deviation management, and Quality expectations.
• Provide peer training and mentorship to…