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Forge Biologics is seeking a Specialist I, QA Operations to join their Quality Assurance team supporting AAV gene therapy manufacturing at their state-of-the-art cGMP facility in Columbus, Ohio. This role is responsible for ensuring compliance with regulatory requirements and maintaining the highest quality standards in a cleanroom manufacturing environment.
Key responsibilities include:
- Serve as a quality resource for the GMP AAV Manufacturing department, providing guidance and communicating quality issues to management during product manufacturing
- Perform detailed review and approval of batch records, associated documentation, logbooks, and controlled documentation to ensure adherence to established procedures and cGMP regulations
- Provide training and guidance to manufacturing personnel on quality-related topics, ensuring proper understanding and adherence to AAV gene therapy manufacturing procedures and regulatory requirements
- Support deviations and continuous improvements related to AAV gene therapy manufacturing processes, including root cause analysis and identification of CAPA (Corrective and Preventive Action) measures
- Collaborate with cross-functional teams including Process Development, Analytical Development, and Manufacturing to support continuous process improvement initiatives
- Support the documentation control process for AAV gene therapy manufacturing, including reviewing and revising SOPs, work instructions, and forms
- Assist in preparation for external audits and inspections, supporting regulatory agencies or client audits specific to AAV gene therapy manufacturing
The position is performed in a temperature-controlled laboratory or office environment and requires regular standing, hand manipulation, and use of laboratory equipment. May involve lifting or moving materials up to 25 pounds and occasional reaching at various heights. Appropriate PPE must be worn when working with chemicals, biological materials, or in controlled environments.
Forge Biologics offers comprehensive benefits including health, dental, and vision insurance (90% premium coverage), competitive paid time off, 12 weeks fully paid parental leave, annual bonus opportunities, 401(k) with company match, onsite fitness facility, mental health counseling, and professional development resources.
QUALIFICATIONS:
- Bachelor's Degree in a scientific or related field (or equivalent experience)
- Previous experience in a quality assurance role within the pharmaceutical or biotechnology industry
- Proven track record of keen attention to detail, consistently ensuring accuracy and precision in all tasks and documentation
