LOCATION: Waltham, MA
TScan Therapeutics is a startup biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Quality Assurance (QA)/Document Control professional to join our team supporting our novel target identification and validation workflow in house. The ideal candidate should have relevant experience in Quality Assurance/Document Control, cGMP compliance, and enjoy fast-paced, collaborative and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
General Responsibilities: Develops, establishes, and maintains Document Control methodologies, systems and practices which meet the applicable regulatory requirements and procedures. Serves as a Quality representative to improve Document Control and Good Documentation Practices awareness of the regulatory and TScan requirements to the different functional areas. Communicates quality initiatives in support of departmental, functional quality goals and priorities. Provides Document Control support to the Quality team and provides documentation support to other teams, as needed. This is a hands-on, non-supervisory position.
T-Scan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScan’s discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.
Responsibilities include but are not limited to:
- Champions Document Control initiatives at TScan Quality
- Authors, revises, reviews, formats TScan documentation in compliance with company procedures, and the applicable regulatory requirements and standards.
- Manages and maintains the Document Control system at TScan that includes, but is not limited to, the organization, issuance, maintenance, archiving, and retirement of documents
- Maintains internal and external libraries at TScan documentation and is the primary liaison with external libraries subcontractors
- Ensures that all documentation is controlled and current
- Generates applicable training materials on Document Controls and GDPs, as needed and as defined in the TScan procedures; conducts related training on a periodic basis and as needed
- Provides guidance and support to teams in generating applicable documentation
- Proactively investigates document control issues, identifies improvements and implements good documentation practices at TScan
- Ensures that all Document Control requirements are met at all stages of the product development process, and manufacturing
- Manages Employee Training documentation including the maintenance of employee training records
- Ensures that all Laboratory Notebooks are controlled, maintained, stored and archived
- Orders, issues, and maintains all applicable logbooks
- Ensures that all company records are maintained, stored and archived according to company procedures and the applicable regulatory requirements and standards
- Associate degree required, bachelor’s degree preferred
- 2-5+ years of quality/document control experience in the pharmaceutical industry or biotech industry
- Working knowledge of compliance best practices for biologics or drug products
- Ability to prioritize, manage time well, multitask, troubleshoot
- Comprehensive knowledge of US Quality System Regulatory (QMS) requirements
- Ability to effectively communicate with a broad spectrum of people having varying backgrounds, education, and experience
- Demonstrated success in delivery of key milestones against tight timelines
- Aptitude to succeed in the culture of a fast-paced, start-up biologics/gene therapy company
- Technical writing skills preferred
- Strong organizational and computer (Microsoft Word, Excel, PowerPoint, Adobe Acrobat) skills required
- Ability to communicate clearly with a variety of individuals in various aspects of TScan operations
- Detail-oriented with expertise in problem solving and solid decision-making abilities
- Strong written and verbal communication skills are essential
Do YOU have the anatomy of a TScanner?
Our talented, compassionate and intelligent team is what makes TScan a great place to work. Our brand new offices with approximately 40,000 square feet of premium lab and office space is an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.