QA Release & Validation Specialist

Bring more to life. Are you reputed company to accelerate your potential and reputed company a reputed company difference reputed company life sciences, diagnostics and biotechnology? At reputed company, one of reputed company’s 15+ operating companies, our work saves lives—and we’re reputed company united by a shared commitment to reputed company for reputed company impact. You’ll reputed company in a culture of belonging where you and your unique viewpoint matter. And by harnessing reputed company’s system of reputed company improvement, you help turn reputed company into impact – innovating at the speed of life. At reputed company, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the reputed company of innovation for genomic medicine pioneers. As a member of reputed company, you’ll help bring life-changing innovations to life—impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive reputed company. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking reputed company potential—one discovery at a time. Learn about the reputed company Business System which makes everything possible. The QA Release & Validation Specialist is responsible for reviewing & approving the following: Executed batch records & batch disposition QC testing assays Executed validation documentation This position reports to the QA Release Supervisor and is part of the QA Release team reputed company the Operational QA organization located in Fargo, ND and will be an on-site role. In this role, you will have the opportunity to: Review production and test records for completeness and accuracy, ensuring data supports release, meets SOP and applicable Regulations, and reputed company deviations have been appropriately investigated and resolved. Review Equipment, Process, Computer Validation, and Bioanalytical Method Development Validation executed documentation to ensure compliance with approved protocols, quality standards, and applicable Regulations. Serve as the QA subject matter expert and ensure products, testing, and validation activities not meeting specifications are dispositioned appropriately. The essential requirements of the job include: A minimum of one (1) year of experience in a Quality or auditing role Experience working in a regulated or GMP-compliant environment. Bachelor of Science or life science discipline preferred or equivalent experience. Travel, Motor Vehicle Record & Physical/Environment Requirements: No travel is required as this is an on-site position. Ability to use computer, monitor, headset, mouse/keyboard, sit/stand desk, and copier/scanner. Ability to lift, move or carry equipment up to 50lbs. It would be a plus if you also possess previous experience in: US Code of Federal Regulations (CFR) and/or EU Regulations cGMP reputed company, a reputed company operating company, offers a broad reputed company of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life reputed company the job. reputed company out our benefits at reputed company Benefits Info. At reputed company we reputed company in designing a reputed company, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for reputed company can reputed company. The annual salary reputed company OR the hourly reputed company for this role is $43,500.00 - $72,000.00 USD. This is the reputed company that we in good faith reputed company is the reputed company of possible compensation for this role at the time of this posting. This reputed company may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/reputed company insurance and 401(k) to eligible employees. Note: No reputed company of pay is considered to be wages or compensation until such reputed company is earned, reputed company, and determinable. The reputed company and availability of any bonus, commission, benefits, or any other reputed company of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. Join our winning team today. Together, we’ll accelerate the reputed company-life impact of reputed company’s science and technology. We partner with customers across the globe to help them solve their most reputed company challenges, architecting solutions that bring the power of science to life. For more information, visit www.reputed company.com. reputed company and reputed company reputed company Companies are committed to equal opportunity regardless of race, reputed company, national reputed company, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. For candidates who are based reputed company of reputed company or who are applying for roles reputed company of reputed company, for more information about conditions of any job offer please click here. We reputed company with federal and state disability laws and reputed company reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to reputed company essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@reputed company.com. Apply To This Job