We are hiring for a Quality Specialist within the gene therapy industry! This role is primarily going to be a desk based role that will support the laboratory, but won't physically be in a lab. An ideal candidate will have somewhere between 6 months - 2 years of experience working in a heavily regulated quality or regulatory role that requires strict documentation procedures. MUST have a Bachelors degree in a scientific field. Example job titles of qualified candidates may include: Quality Laboratory Technician, Quality Analyst, Regulatory Technician, Product Safety Specialist, or something similar. Examples of relevant industries may include: Pharmaceutical, Biotech, Food, Cosmetics, or anything else that may be GMP, FDA, or similarly regulated. Job Description: The individual will work primarily with the Quality Control Laboratory to support the testing and analysis of cGMP produced viral vectors and cells. This role will not be performing laboratory testing itself, and will be focused on the documentation/desk based side of the team. It involves close collaboration with the QC manager and senior QC staff to cultivate and enact strategic direction in the GMP area. + Perform report writing. + Updating and writing SOPs. + Perform documentation related to material release. + Perform data logging. + Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF. + Identify gaps and implement improvements in processes associated with sample management. + Complete, review, file, and archive documentation according to Standard Operating Procedures (SOPs). + Document all activities performed according to GMP, cGMP, GLP, and QC standards. Environment: + The quality laboratory that you will be working with performs testing on manufactured gene therapy products before they are released to the client. + They primarily work in a cleanroom and run microbiological assays on these products. Essential Skills + Bachelors Degree in a scientific field + 6+ months of experience working in a heavily regulated quality laboratory, quality documentation, or regulatory environment. Pay and Benefits The pay range for this position is $24.00 - $24.00/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 Sep 4, 2025. 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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.