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Analyst I, QC Raw Materials

Forge Biologics
5 hours ago
Full-time
On-site
Columbus, OH, United States
LinkedIn

Forge Your Future with Us: At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins. Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases. What sets Forge apart is our culture of H.O.P.E. We are hardworking , showing up each day with determination and grit. We are open , creating a space where ideas flow freely, and every voice is valued. We are purpose-driven , with every task directly tied to changing lives. And we are engaged , energized by the challenges we face and the milestones we achieve together. At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us. If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself. About The Role: We are currently seeking an Analyst I , Quality Control (Raw Materials) to join the Forge Biologics team. In this role, you will be responsible for performing incoming inspection to evaluate raw materials used in AAV vector production against all Forge defined requirements. Your work will involve executing various processes defined within SOP documents in a cGMP compliant manner. Additionally, you will be responsible for performing comparisons between measured results and expected criteria and communicating those comparisons in a timely and thorough way. Your contribution will be essential in maintaining the integrity and safety of our gene therapy products. Responsibilities: Inspect all materials that arrive at the facility for integrity and quality. Communicate between departments to ensure operations teams have all required materials. Facilitate a range of activities to support material testing, including but not limited to identity, purity, potency, and microbial contamination, on incoming and Forge produced raw materials. Accurately document test results, observations, and procedures in accordance with Good Documentation Practices (GDP). Collaborate with the procurement team to ensure timely receipt and disposition of raw materials. Escalate any non-conformance or deviations to appropriate channels for investigation and resolution. Assist in the development and optimization of practices and procedures. Contribute to the maintenance, calibration, and qualification of laboratory equipment. Adhere to Standard Operating Procedures (SOPs), cGMP guidelines, and regulatory requirements. Maintain a clean and organized work space and adhere to safety protocols. Qualifications: Bachelor’s Degree in Biology, Biochemistry, Chemistry or a related discipline. Preferred Skills: Prior experience in a laboratory or quality control environment. Understanding of cGMP and regulatory guidelines. Competencies: Attention to detail, accuracy, and the ability to follow protocols. Strong organizational and documentation skills. Effective communication and ability to work within a team. Willingness to learn and adapt to new techniques and technologies. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the em…

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