Specialist II, Quality Assurance

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization. Located in Columbus, OH
, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non‑cGMP activities.

The Quality Assurance (QA) Specialist II is an individual contributor role that provides compliance and quality improvement support. This role reports to the QA Supervisor for Operations and Change Control and works closely with the Andelyn Operations staff to ensure manufacturing operations are compliant with applicable regulations, policies, and procedures.

• Provide day‑to‑day support to the Operations team so production timelines are met
• Work closely with Facility staff to support activities that ensure control of the manufacturing cleanroom
• Represent the QA group in continuous improvement committees or working groups and incorporate process‑improvement tools to guide these groups
• Assist with investigations, deviations, CAPA, validation documentation, change control, and other related controlled documents
• Review Quality System data for trends within the assigned area, report findings to functional area management, QA, and provide quality‑improvement training for staff as needed
• Perform QA functions related to Operations, including internal audits, document review and approval, and batch record disposition
• Routinely identify quality issues and report them to senior QA staff and management
• Provide support to QA Management for third‑party audits
• Assist in the raw‑material release process by assuring suitability of production materials
• Help identify areas for quality improvement and work with senior QA staff and management to develop action plans and metrics to monitor progress toward quality‑improvement objectives
• Exercise discretion, judgment, and personal responsibility
• Demonstrate a high level of integrity
• Maintain compliance with applicable regulatory requirements for cellular and gene‑therapy products
• Pay attention to detail in all job functions
• Operate in alignment with established policies, procedures, and techniques, requiring relevant training, practical experience, or a working knowledge of the tasks involved
• Solve, correct, and prevent problems, and perform tasks as assigned by leadership, including assigning tasks to junior staff
• Plan to achieve specific measurable objectives with limited direct supervision
• Lead and support a diverse and collaborative team environment, utilizing clear and concise communication to deliver high productivity and contribute to team success
• Document all activities performed according to SOPs
• Make decisions based on established procedures
• Show fiscal responsibility
• Engage moderately in customer relations
• Take moderate responsibility for inspection outcomes
• Influence hiring, development, and related personnel processes
• Mentor and develop staff professionally
• Perform other duties as assigned

• Must possess a relevant four‑year degree, or a relevant Master’s or PhD
• Three years of relevant experience (with a four‑year degree) or no experience (with a Master’s)
• Experience in biologics or gene‑therapy required
• Experience in a highly regulated field preferred; knowledge of FDA regulatory requirements and aseptic processes preferred
• Excellent communication, organization, and project‑management skills, with the ability to manage multiple projects efficiently and adjust priorities as they change
• High proficiency in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting
• Ability to work independently as well as collaboratively in a diverse and inclusive work environment
• Client‑focused mindset in daily tasks
• Prior experience handling confidential information and maintaining confidentiality

• The pride of contributing to the development and manufacturing of life‑saving therapies
• The invaluable experience of building the foundation of a new organization
• Opportunity to work alongside experts with…