Job Information
Actalent Quality Assurance Specialist/Auditor (Sciences) in Columbus, Ohio
We are hiring for a Quality Specialist/Auditor role 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 at least 3+ years of Quality Assurance experience, with at least a year of it being involved in investigations and deviations. Experience must come from a heavily regulated environment such as GMP, FDA, GLP, or anything similar.
Job Description
The Quality Assurance Specialist/Auditor provides compliance oversight and quality improvement support for Investigational New Drug biologics manufacturing and related facility operations. You will help plan, schedule, conduct audits and performs administrative tasks that support the quality management program ensuring that all aspects are complying with applicable regulations and policies.
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.
Minimum of 3 years of quality or regulatory experience.
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 - $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)
Workplace Type
This is a fully onsite position in Columbus,OH.
Application Deadline
This position is anticipated to close on Apr 27, 2026.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.