Title: Quality Assurance Validation Manager
Location: Alachua, Florida
Reporting to: Director of Quality Assurance
Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is on a mission to manufacture safe, efficacious, and scalable gene therapies. Our vision is to set a new standard for gene therapy manufacturing through continuous scientific and process innovation. Our teams, rooted in biopharma, possess regulatory knowledge and prioritize the quality and potency of manufacturing high-class products.
Our goal is to inspire the next generation of experts and breakthrough start-ups in the gene and cell therapy field. With a startup mindset and a track record of rapid growth, we aim to exceed boundaries and achieve continued success. Join us to pursue your passion and make a difference in the industry where there are no limits to what we can achieve.
Mission As the Quality Assurance Validation Manager, you will play a pivotal role in ensuring the highest standards of quality and compliance. You will review and oversee Commissioning, Qualification, and Validation (CQV) and Computer Software Validation (CSV) documentation for Quality Control (QC) and Manufacturing (Mfg.) equipment, Computerized Systems, Utilities, and Facilities using GAMP 5 methodology. Your expertise in regulated environments will ensure our operations maintain rigorous validation standards, meeting both quality and business objectives efficiently.
Key Responsibilities
Requirements
Benefits
Aim Higher – Our motto and values.
To start your journey with us at Ascend, kindly submit your resume and a cover letter showcasing your qualifications and interest in the role. We value diversity and oppose discrimination. While we eagerly await all applications, we'll only reach out to selected candidates for interviews. Please note that successful candidates must be legally authorized to work in the United States and will undergo E-verify authentication. Thank you for considering joining our team as we shape the future together!
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