What are the responsibilities and job description for the QA Operations Specialist/Senior Specialist position at TScan Therapeutics?
Position Summary:
TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for experienced Quality Assurance professional to join our team as Quality Assurance Operations Specialist/Sr. Specialist, supporting the companys novel TCR-engineered T cell therapy products. Reporting to the QA Operations Manager, the ideal candidate should have relevant experience in Quality Assurance, batch record reviews, cGMP compliance, and enjoy fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
Responsibilities:
- Provide quality on-the-floor support of manufacturing, reviewing documentation and providing real-time support of manufacturing issues.
- Support quality operations activities such as batch record and QC data reviews.
- Support raw material and clinical product disposition activities
- Support quality decisions that may impact operations ensuring appropriate escalation to management.
- Support the identification, evaluation and mitigation of risks and communication of gaps for quality and GMP processes.
- Initiates and assists in investigations of Quality Systems documentation (deviations, change controls, CAPAs, Out of Specifications/Tolerances etc.)
- Support activities for various project(s) to ensure that the project timeline/schedule is met.
- Maintain compliance with internal procedures, regulations, and external standards as deemed appropriate to the task/role
Requirements:
- Bachelors degree preferred
- 3-5 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
About TScan:
TScan Therapeutics is a fully integrated, next-generation TCR-T cell therapy company. Founded in 2018, TScans platform was developed by Stephen Elledge, Ph.D., and Tomasz Kula, Ph.D., at Brigham and Womens Hospital and Harvard Medical School. TScans transformative platform enables rapid discovery of TCRs and targets for engineered T cell therapy. This technology is extremely versatile and is applicable across multiple therapeutic areas beyond cancers, including autoimmune disorders and infectious diseases.
Do YOU have the anatomy of a TScanner?
Our talented, compassionate, and intelligent team is what makes TScan a Top Place to Work (as ranked by The Boston Globe). Our state-of-the-art offices with over 70,000 square feet of premium lab space, including an internal GMP manufacturing suite, are an environment that supports innovation, camaraderie, and professionalism. We are passionate, fun, flexible, and team oriented. Sound like you? Apply today.
EEO Statement
TScan is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. TScan provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with TScan regarding a reasonable accommodation in connection with the hiring process and/or to perform the responsibilities of the position for which the applicant has applied, please contact the recruiter.
Recruitment & Staffing Agencies
TScan Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to TScan Therapeutics or its employees is strictly prohibited unless contacted directly by TScan Therapeutics internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of TScan Therapeutics, and TScan Therapeutics will not owe any referral or other fees with respect thereto.
