Job DetailsQuality Assurance Specialist Contractor Bedford, MA About Us... Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian's programs apply our cytoDRiVE platform technology to express regulated therapeutic proteins to enhance anti-tumor activity. We're currently investigating our lead program OBX-115 and enrolling patients in an ongoing clinical trial in advanced or metastatic melanoma. We're proud of our diverse talented team and committed to cultivating an environment where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our research team is based in the heart of Cambridge, MA, and our Technical Development, Manufacturing & Quality team is based in our facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options. On April 3, 2024, we announced closure of a significantly oversubscribed $160.5 million Series C financing with a top-tier syndicate of life science investors led by new investor, Wellington Management. Proceeds from the financing will advance Obsidian's lead program in its ongoing trials. We're focused on enrolling patients and reaching key clinical and regulatory milestones, as well as manufacturing scale-up ahead of pivotal trial readiness.Our Opportunity... We're looking for a motivated, experienced, purpose driven Quality Assurance Specialist Contractor to plan, coordinate, and execute a critical project to support compliance with all regulatory requirements. As part of our Quality Assurance team, you'll be a vital part of a highly collaborative team working to achieve Obsidian's vision by translating innovative science into medical breakthroughs for patients, starting with our lead program OBX-115. This is a remote role; candidates within driving distance to our Bedford, MA location are preferred for easy access for on-site meetings if warranted. You Will...
- Provide QA support for the migration of a variety of controlled quality documents into Obsidian document repository.
- Review existing quality, analytical, process, and manufacturing SOPs and associated documents and reports and properly and accurately label for future migration activities.
- Create searchable metadata to easily find and retrieve documents for future use.
- Collaborate with IT, QA, Analytical Development, Process Development, and other key partners.
- Contribute to continuous improvements of department processes.
- Assist with improvement of Quality Systems, including but not limited to internal document review, change controls, deviations, investigations, and review of batch records.
You Bring... Core Qualifications
- Bachelor's degree in biology, chemistry, engineering, life sciences or a related field, and 3+ years of relevant work experience (or M.S. and 1+ years of relevant work experience).
- Understanding of GMP requirements and best practices in drug development.
- Experience with QA document control and management and Quality Systems.
- Experience with management of controlled documents such as SOPs, manufacturing batch records, test records, deviations, CAPAs, and other quality records.
- Experience with both paper and electronic QMS systems.
- Strong command of SharePoint and labeling of quality documents.
- Strong knowledge of GMP, SOPs, and quality system processes.
- A team mindset and highly collaborative working style.
- Ability to communicate effectively with scientific/technical colleagues, and effectively collaborate in a dynamic, cross-functional environment.
- Ability to manage and deliver multiple projects in a fast-paced environment.
- A systems thinker. Approaches problem solving and process design from with consideration of the overall system as well as its individual parts; considers interrelationships and patterns.
- Demonstrates context-based sound judgement.
Bonus Qualifications
- Experience in cell therapy or biologics.
- Familiarity with FDA and EMA guidance documents relevant to gene and cell therapy analytical development and method validation.
- Contribution to the implementation of an electronic QMS system.
- Quality systems experience (Trackwise, Veeva, SAP CAPA, Documentum etc.).
Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.