Quality Assurance Specialist - Gene Therapy

This role is based in Columbus, Ohio, and supports compliance and integrity initiatives within gene therapy research, working across multiple groups.

About the role

The Biologics Quality Assurance Auditor provides critical compliance and quality improvement support for phase 1/2a Investigational New Drug biologics manufacturing and facility operations. Working closely with the Quality Assurance Manager, this role plans, schedules, and conducts audits, oversees documentation, and supports the broader quality management program. The auditor ensures that biologics manufacturing and facility activities remain compliant with applicable regulations, policies, procedures, and phase-appropriate current Good Manufacturing Practices (cGMP), while driving quality and process improvement initiatives across the organization.

Responsibilities

• Operate within established Quality Management Systems applicable to Investigational New Drugs and Good Tissue Practices.
• Maintain up-to-date knowledge of phase-appropriate FDA and international cGMP regulations for Regenerative Medicine, Cell Therapy, and Good Tissue Practices.
• Lead data review processes to support biologic IND product release, ensuring accuracy, completeness, and compliance.
• Deliver training on GMP and Good Documentation Practices to manufacturing and support personnel.
• Lead Quality Assurance functions related to quality programs, including process audits, laboratory audits, and protocol approvals, as assigned.
• Coordinate with Biologics Manufacturing Operations and the Quality Assurance Manager to plan and conduct vendor and supplier facility audits.
• Support the Quality Assurance Manager in mentoring and training QA staff as needed.
• Support the Quality Assurance Manager during client and regulatory audits, including preparing for and participating in records reviews.
• Manage, review, and approve controlled documents, including but not limited to procedures, methods, and test protocols, to support effective biologics manufacturing and Good Tissue Practices.
• Provide additional quality assurance, auditing, and compliance support to the Quality Assurance Manager as requested.
• Collaborate closely with cross-functional teams in areas such as cell therapy, research, flow cytometry, and tissue culture to support quality objectives.
• Handle multiple tasks and priorities simultaneously in a rapidly growing department while maintaining high standards of quality and compliance.

Requirements

• Bachelor’s or Master's degree in a scientific discipline.
• Quality Assurance experience in heavily regulated environments such as GMP, FDA, GLP, or similarly regulated environments.
• Experience working with CAPAs and deviations.

Pay

The pay range for this position is $28.00 - $30.00 per hour.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this role may include:

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital insurance
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short- and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Schedule

This is a permanent, fully onsite position in Columbus, Ohio.