Quality control analyst jobs in Bloomington, IN

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY The QC Analyst II is responsible for performing and supporting a broad range of advanced laboratory functions related to viral vector production and analytics in accordance with cGMP testing guidelines. In this role, the analyst independently executes complex molecular biology assays, aseptic cell culture techniques, and analytical testing with minimal supervision. The position also includes responsibilities for sample and materials management, solution/media preparation, and general lab maintenance, with an increased emphasis on method troubleshooting, data review, and deviation documentation. The QC Analyst II contributes to method qualification, equipment calibration and validation, and supports continuous improvement efforts. This role serves as a technical resource for junior analysts, helping to uphold quality standards and drive operational excellence within the Quality Control team. ESSENTIAL JOB FUNCTIONS Independently manage ordering, inventory control, and lifecycle tracking of lab reagents and critical materials to ensure uninterrupted testing operations Coordinate and oversee sample organization, prioritization, and testing workflows with minimal supervision Lead sample shipping and receiving processes for internal and outsourced testing, ensuring accurate chain of custody and compliance with applicable regulations Execute complex hands-on laboratory procedures related to viral vector production and analytical characterization, including troubleshooting and optimization of methods Review and ensure accurate, compliant cGMP documentation of laboratory activities; support deviation investigations and CAPA implementation as needed Perform advanced laboratory and equipment maintenance, and coordinate with internal teams or vendors for calibration, qualification, and repair activities Serve as a technical trainer and mentor to new staff and junior analysts, supporting their development and adherence to best practices Ensure compliance with all established policies, SOPs, and cGMP requirements while identifying opportunities for procedural improvements Collaborate with Quality Assurance and leadership in the development, review, and revision of SOPs, protocols, and related documentation Responsible for attending client project meetings, tracking related QC activities and ensuring timely execution of project milestones. Actively support and contribute to method qualification, validation, and transfer activities, including drafting protocols, analyzing data, and preparing summary reports SPECIAL JOB REQUIREMENTS Adaptability required as work schedule may change based on business needs Criminal background check required Other duties as assigned KNOWLEDGE, SKILLS AND EXPERIENCE EDUCATION / CERTIFICATIONS / LICENSES Essential/Desired Associate or BS degree in Biology, Biochemistry, Molecular Biology, or similar field Essential ON-THE-JOB EXPERIENCE 2+ years of relevant industry experience in QC, R&D, product development, or operations Essential SKILLS / ABILITIES Excellent computer, verbal, and written communication skills Essential Experience with laboratory techniques including cell culture, cell-based assays, qPCR, dd PCR, flow cytometry, ELISA, and/or biostatistical analysis Essential PHYSICAL DEMANDS While performing the duties of this job, the employee is required to meet the following physical demands: Work Environment Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock Occasionally exposed to extremely loud noise levels Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required. Movement Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl Lifting Frequently lift and/or move up to 10 pounds Occasionally lift and/or move up to 25 pounds Vision Frequently utilize close vision and the ability to adjust focus Communication Frequently required to communicate by talking, hearing, using telephone and e-mail GENEZEN'S CURES VALUE-BASED COMPETENCIES Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare. Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs. Resilience & Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. Execute with Excellence & Integrity We are dedicated to delivering quality results and upholding ethical principals. Solutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner. GENEZEN'S BENEFITS Paid vacation days, amount based on tenure Paid sick time 10 observed holidays + 2 floating holiday + 1 volunteer day 401(k) plan with company match up to 6% of salary, vested immediately Share Appreciation Rights Choice of several healthcare plans FSA and HSA programs Dental & vision care Employer-paid basic term life/personal accident insurance Voluntary disability, universal life/personal accident insurance Accidental Death & Dismemberment (AD&D) Insurance ADDITIONAL DETAILS Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time. This position requires a criminal background check. Genezen is an Equal Opportunity Employer. Genezen participates in EVerify. Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas. Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live. Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.