Quality Assurance Operations Specialist

About Forge 

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.   

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.  

About The Role  

We are currently seeking a Quality Assurance Operations Specialist join the Forge Biologics Team. In this role, you will be responsible for ensuring compliance with regulatory requirements and maintaining the highest quality standards. The Specialist will provide expert support to the Quality Assurance team in activities such as document control, batch record review, deviation management, internal and external audits, training, and continuous improvement initiatives specific to AAV gene therapy manufacturing.

What You’ll Do  

• Lead and manage the document control process for AAV gene therapy manufacturing, ensuring compliance with regulatory requirements, industry best practices, and internal quality standards.
• Conduct detailed review and approval of complex batch records and associated documentation for AAV gene therapy manufacturing, ensuring adherence to established procedures and cGMP regulations.
• Provide expert guidance and support in the investigation of deviations and non-conformances related to AAV gene therapy manufacturing processes, performing in-depth root cause analysis and implementing effective CAPA measures.
• Plan and execute internal audits of AAV gene therapy manufacturing activities, leading audit teams, assessing compliance with cGMP regulations and quality systems, and driving corrective and preventive actions.
• Prepare and participate in external audits and inspections, ensuring successful outcomes and addressing observations or findings related to AAV gene therapy manufacturing.
• Develop and deliver comprehensive training programs for manufacturing personnel on quality-related topics, ensuring consistent understanding and adherence to AAV gene therapy manufacturing procedures and regulatory requirements.
• Lead and support cross-functional teams, providing expert quality oversight for AAV gene therapy manufacturing, process improvement initiatives, and alignment with quality objectives.
• Establish and maintain effective partnerships with internal stakeholders, including Process Development, Analytical Development, and Manufacturing, to ensure quality assurance goals are met and maintained.
• Ensure accurate and up-to-date documentation of all quality assurance activities related to AAV gene therapy manufacturing, maintaining compliance with record-keeping requirements.
• Monitor regulatory requirements, industry trends, and best practices related to AAV gene therapy manufacturing, and implement necessary changes to maintain compliance and drive continuous improvement initiatives.

What You’ll Bring  

• Bachelor’s Degree in a scientific or related field (or equivalent experience).
• 3-5 years of experience in a quality assurance role within the pharmaceutical or biotechnology industry.
• In-depth knowledge of cGMP regulations, quality systems, and quality assurance principles.
• Proven experience managing document control processes and systems, including SOPs, work instructions, and forms.
• Extensive experience in reviewing and approving batch records for manufacturing, ensuring compliance with cGMP regulations.
• Strong expertise in deviation management processes including in-depth root cause