Quality Assurance Co-Op (Spring 2027)

 

About Us…

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our cytoDRiVE® technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in clinical development for the treatment of patients with metastatic melanoma and non-small cell lung cancer.

We’re proud of our diverse talented team and committed to cultivating an environment of inclusion 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 Technical Operations team is based in our purpose built facility in Bedford, MA.   

 

Our Opportunity...

We are looking for a highly motivated, scientifically curious, flexible, and collaborative Quality Assurance Co-Op to join our Quality Assurance team. You’ll assist with organizing GxP Quality Assurance documentation, creation of QA dashboards and trackers, and be involved with QA training plans.  You will gain overall knowledge of Quality Assurance activities for a dynamic cell therapy biotech company.  You will be part of a highly collaborative team committed to transforming innovative science into meaningful medical breakthroughs for patients, beginning with our lead autologous tumor‑infiltrating lymphocyte (TIL) therapy program treating cancer (currently metastatic melanoma and non-small cell lung cancer  

As a member of our Quality Assurance department, you will be a vital part of a highly collaborative group working to unlock the promise of precision cell therapy for patients, starting with our lead program amsoki-cel (OBX-115), a novel engineered tumor-infiltrating lymphocyte (TIL) cell therapy that uses our proprietary cytoDRiVE® platform. This is a unique opportunity to be a valuable contributor in a well-funded clinical company with field-leading advisors, best-in-class partners, and an experienced team.     

 This is a Hybrid role based out of our Bedford, MA location. 

Work Outcomes...

• Support implementation of the Electronic Document Management System (eDMS) and transition to a new Learning Management System (LMS) 
• Support the migration of legacy documents from the paper-based system to the eDMS 
• Assist with document issuance, revision and archival activities 
• Review training records and update training files 
• Create and update eDMs and LMS reports 
• Support the development and maintenance of the role-based training curricula 
• Support quality system initiatives 

Learning Outcomes...

This role will provide hands on exposure to a regulated GxP environment while developing quality, compliance, and professional skills: 

• Document management: organizing, formatting, reviewing, issuing, revising, and maintaining controlled documents 
• Attention to details: identifying errors, inconsistencies, missing information, and version-control issues 
• Training administration: supporting training assignments, curricula, and training reports and dashboards in an Learning Management System (LMS) 
• Data and metrics: collecting and analyzing training, document control data and supporting quality metrics 
• Process improvement: identify opportunities to streamline training and document control processes and improve efficiency 
• Collaboration and communication: working closely QA, SME’s, Digital Technology and Solutions (DS&T) 
• Problem solving investigating discrepancies and help determine appropriate corrective actions 
• Use of and Electronic Management System (eDMS), Learning Management System (LMS), Adobe Sign 
• Fundamentals of GxP and Good Documentation Practices (GDP) 

You Will...

Core responsibilities

• Contribute to the organization of controlled GxP documents 
• Perform a gap assessment of documentation on a validated SharePoint site, create a plan for mitigation of omitted documents, and assist with migration on to the electronic Document Management System  
• Assist with creating and improving trackers and Dashboards for quality data such as document trackers, lot disposition trackers, management review dashboards, and other key performance indicators 
• Propose tracker simplifications or automation ideas to better display data 
• Reconcile tracking spreadsheets against source data such as shipping tracking data 
• Monitor the Quality System & Compliance email inbox and respond to Vendor Notification requests or other requests as applicable 
• Contribute to Quality Assurance Standard Operating Procedure (SOP) formatting 
• Assist with training activities, help organize and maintain training files and records 
• Make intellectual and technical contributions to projects, while working on a collaborative team 

You Bring...

Core Qualifications

• Enrollment in an undergraduate (Bachelor’s) degree program in Biology, Chemistry, Engineering, or related major.  
• Proficiency in building and use of Excel spreadsheets 
• An interest in learning about Quality Assurance in cell therapy manufacturing 
• High level of motivation and ability to work both independently and collaboratively 
• Adaptability, scientific curiosity, and desire to learn new skills 
• Excellent organizational skills and attention to detail as applied to record-keeping 
• Attention to detail, including as applied to record-keeping 
• Self-motivated, with a proven ability to meet objectives, timelines, and high standards managing multiple responsibilities in parallel.    
• Flexible - adapts to change in a fast paced, rapidly developing environment  
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner  
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments, operates with urgency. 

Bonus Qualifications

• Ability to learn and navigate electronic systems and/or familiarity with Electronic Document Management System and Learning Management System.  

*Salary will be commensurate with experience and qualifications; candidates with relevant prior co‑op experience and/or critical skills may receive a higher hourly rate.

 

Why Join Obsidian… 

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. Join us to make a positive impact on patients, grow your career, and work with a great team. 

As a Co-Op at Obsidian, you will build upon the skills that you’ve obtained through your studies and gain hands on experience that will help prepare you for future full-time opportunities in the industry. You will gain exposure to the biotechnology industry and learn how to be effective in a professional setting. You will work closely with a highly collaborative and welcoming team working to advance Obsidian’s mission. 

Not only will you have a dedicated mentor, but you will also have regular interaction with members of the team working on other projects.  Past Co-Ops have found Obsidian to be a welcoming environment offering exceptional opportunities to learn through meaningful work and collaboration with talented, experienced, and supportive colleagues who encourage questions and exploration. 

Our Co-Ops receive a market competitive hourly rate and are able to take advantage of Obsidian’s Commuter Benefits to assist with commuting costs. And who doesn’t love a free lunch? Lunch selections are available from a variety of surrounding restaurants and is delivered daily in both our Cambridge and Bedford locations! Having lunch delivered allows us to gather together and build personal connections. We have a variety of fun social networking opportunities available through our Social Committee including activities like kayaking outings, fitness challenges, food festivals, after work get-togethers and other events. 

We also offer networking opportunities throughout your Co-Op experience.  You will have the opportunity to meet team members from cross-functional groups and learn about various functions that contribute to drug development.  We offer opportunities to chat with Scientists about their career paths.  You will also receive guidance on resume writing, how to use LinkedIn effectively, and job search coaching. 

 

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.