Quality Assurance Specialist - Gene Therapy

Job Description

Job Description

We are hiring for a Quality Specialist/Auditor role in the Gene Therapy field here in the Columbus, Ohio area! This role will be working within compliance and integrity to support multiple different groups in gene therapy research.

An ideal candidate for this role will have a Bachelors or a Masters Degree and quality assurance experience being involved in investigations and deviations. Experience must come from a heavily regulated environment such as GMP, FDA, GLP, or similarly regulated environments.

Job Description

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.

Qualifications:

• Bachelor’s or Master's degree in a scientific discipline.
• Must have Quality Assurance experience in heavily regulated environments and working with CAPAs and deviations.

This is a Permanent position based out of Columbus, OH.

The pay range for this position is $28.00 - $30.00/hr.

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 temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 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)

This is a fully onsite position in Columbus,OH.

This position is anticipated to close on Aug 19, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.