Quality Control Documentation Technician

Quality Control Technician

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Job Description The Quality Control Technician works primarily in the Quality Control (QC) Laboratory to support the testing and analysis of cGMP-produced viral vectors and cells. This role operates within a regulated environment and focuses on executing QC methods, managing product samples, and maintaining accurate documentation to support the manufacture of phase-appropriate cellular and gene therapy materials. The position collaborates closely with sr QC staff and leadership to ensure high-quality results, robust compliance, and continuous improvement in QC operations. Responsibilities Perform routine QC testing and analysis on cGMP-produced viral vectors and cells in the Quality Control Laboratory. Run assigned sample assays consistently, including performing the same assays on a regular nightly schedule, typically five nights per week. Operate, calibrate, validate, clean, and maintain QC laboratory equipment according to established procedures. Execute QC methods and support method development under the guidance of sr staff. Analyze microbiological environmental monitoring samples and document results accurately. Write and revise Standard Operating Procedures (SOPs) related to QC activities, equipment, and processes. Perform equipment maintenance and monitoring to ensure reliable and compliant operation. Manage materials and supplies for QC and Production, ensuring appropriate inventory levels and proper handling. Assist periodically with cleaning and upkeep of clean room facilities to maintain controlled conditions. Provide periodic assistance with the manufacturing of viral vector products as needed. Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the clinical manufacturing facility (CMF). Ensure all product samples are accurately labeled and that sample allocation, storage, and transitions are documented in the required formats and systems. Maintain full accountability for product samples as they are allocated across different testing requirements and storage conditions. Evaluate sample management processes to identify gaps and implement improvements that enhance efficiency and compliance. Complete, review, file, and archive documentation in accordance with SOPs and regulatory expectations. Maintain compliance with applicable regulatory requirements for cellular and gene therapy products, including cGMP and GLP principles. Perform work in accordance with established policies, procedures, and techniques, applying training and working knowledge related to assigned tasks. Work under the close supervision of SR staff and leadership while progressively building technical and regulatory expertise. Function effectively in a diverse, collaborative team environment, using clear communication to support high productivity and smooth cross-functional interactions. Document all activities performed in a timely, accurate, and compliant manner. Essential Skills Demonstrated experience or training in biology, virology, or related research disciplines. Hands-on exposure to GMP or cGMP environments, with an understanding of regulatory and documentation requirements. Working knowledge of Quality Control principles and practices in a laboratory setting. Familiarity with GLP standards and their application to QC testing and documentation. Ability to perform and follow QC methods and procedures with high attention to detail. Capability to operate, calibrate, and maintain laboratory instruments and equipment. Strong documentation skills, including accurate recording, reviewing, and archiving of data and records according to SOPs. Ability to work effectively under close supervision while following established policies and procedures. Strong communication skills to collaborate within diverse, cross-functional teams. Comfort working in clean room environments and adhering to strict cleanliness and contamination control procedures. Additional Skills & Qualifications Degree in Biology or another relevant scientific field. Experience in aseptic technique and working in controlled or clean room environments. Experience with mammalian cell culture techniques. Hands-on experience with PCR and ELISA procedures. Preferred experience in GMP manufacturing operations. Understanding of regulatory expectations and documentation constraints in a GMP setting. BG in molecular biology, virology, or related scientific disciplines. Ability to contribute to method development and process improvement initiatives. Comfort working in a rapidly growing, evolving organization with new facilities and technologies. Work Environment The role is based in a rapidly growing organization that is expanding into new, state-of-the-art facilities in Columbus, Ohio. The work takes place in modern clean rooms and laboratories equipped with advanced technologies and equipment designed for cellular and gene therapy manufacturing and quality control. Team members work in cross-functional, collaborative groups that bring together QC, manufacturing, and other functions to support shared goals. The environment emphasizes regulatory compliance, meticulous documentation, and adherence to clean room practices while fostering innovation and continuous improvement in a fast-paced setting. Job Type & Location This is a Contract to Hire position based out of Columbus, OH. Pay and Benefits The pay range for this position is $22.00 - $22.00/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 May 16, 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.