Quality Specialist/Auditor - Gene Therapy

We are hiring for a Quality Assurance Specialist/Auditor to help support the manufacturing of phase 1/2a new drugs (primarily in gene therapy). This role will be entirely desk based and more documentation focused long-term. This role will NOT be working in the lab.

An ideal candidate will have a Bachelors Degree in a Scientific field and at least 2 years of experience working in highly regulated environments (GMP, GLP, FDA, etc.). Candidates can come from either laboratory backgrounds or scientific documentation focused roles.

Job Description

The Quality Assurance (QA) Auditor provides compliance and quality improvement support to the manufacture of phase 1/2a Investigational New Drug, Biologics manufacture, and facility operations. This role collaborates with the Quality Assurance Manager to plan, schedule, and conduct audits and administrative tasks to support the quality management program. The position ensures compliance with applicable regulations, policies, procedures, and expectations of phase-appropriate current Good Manufacturing Practices (cGMP). The QA Auditor I will also engage in various quality improvement and process improvement initiatives.

Responsibilities

• Operate within the Quality Management Systems applicable to Investigational New Drugs and Good Tissue Practices.

• Maintain a current knowledge of applicable phase-appropriate FDA and International cGMP regulations for Regenerative Medicine, Cell Therapy, and Good Tissue Practices.

• Lead data review processes to facilitate biologic IND product release.

• Perform GMP and Good Documentation Practices training for manufacturing and support personnel.

• Lead QA functions related to the Quality programs, such as process and laboratory audits, protocol approvals, etc., as assigned.

• Coordinate with Biologics Manufacturing Operations and QA Manager to perform vendor facility audits.

• Support the QA Manager in mentoring and training QA staff as needed.

• Assist the QA Manager during client and regulatory audits, as well as client audits for records review.

• Manage, review, and approve controlled documents necessary for the effective functioning of biologics manufacture and good tissue practices.

• Provide additional support to the Quality Assurance Manager as required.

Qualifications

• Bachelor's degree in a scientific discipline with a minimum of 1-2 years of highly regulated experience (either in laboratory, quality, or regulatory related positions)

Job Type & Location

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

Pay and Benefits

The pay range for this position is $28.00 - $28.00/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)

Workplace Type

This is a fully onsite position in Columbus,OH.

Application Deadline

This position is anticipated to close on Mar 20, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.