Job Title: QA Document Specialist
Location: Louisville, KY
Reports to: Head of Quality Assurance
Direct Reports: None
Talaris Therapeutics, Inc. (“Talaris”) is a late-clinical stage biotechnology company that is developing transformative cell therapies with the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients as well as induce durable remissions in patients with severe autoimmune and immune-mediated disorders. Achieving durable, drug-free immune tolerance to a donated organ has been referred to as a “Holy Grail” of organ transplant. In a ground-breaking, phase 2 study conducted between 2009 – 2016, our lead therapy, FCR001, enabled 70% of living donor kidney transplant recipients to be weaned off all immunosuppression within 12 months of their kidney transplant, without rejecting their donated organ. The benefits of our therapy have been shown to be extremely durable. We have followed these patients for an average of over five years since their transplant, and the longest for over ten years, and not a single patient who was tolerized in our phase 2 study has subsequently had to resume immunosuppression. Since late-2018, Talaris has raised over $190M in private financing from leading life sciences investors and has initiated a Phase 3 registration trial of our therapy in living donor kidney transplant patients. In 2021, the company also plans to initiate Phase 2 trials of FCR001 in scleroderma as well as in patients who have previously received a living donor kidney transplant. Our cell processing facility is based in Louisville, KY, and we have a corporate office in Boston, MA
The QA Document Specialist is responsible for maintaining and sustaining change control, training and documentation processes. Supports departments by creating, processing, distributing and controlling revisions of the quality system and related documentation. Looking for a hands-on Quality Assurance Document Specialist who will assist and coordinate the creation, routing, approval and archival of QMS, CMC, Clinical, and Regulatory documentation (e.g. Reports, Regulated Filing Sections, Protocols, etc.). In addition, the role will also help track and organize QMS activities, including training, audit coordination (pre-post), non-conformance tracking, etc. This role will ensure that documentation timelines for GxP activities and regulatory submission activities are coordinated in a manner that complies with company timelines and applicable laws, regulations, standards, and guidelines. This role will also be responsible for maintaining, updating, and enforcing the company’s good documentation policies.
Principal Duties and Responsibilities:
- Coordinates and maintains document training records utilizing Veeva EDMS
- Provides training as the Subject Matter Expert (SME) on the document control & document training process
- Prepares and presents KPI status reports, as needed
- Assigns and monitors document numbers, part numbers, & updates logs and databases
- Coordinates the review and revision of procedures, specifications, and forms with the functional groups, as needed
- Receives, reviews, controls, and tracks documents per relevant process and procedures
- Identify any gaps in the document control process and provide process improvements to the document control system
- Authors and implements procedures related to document control system
- Ensure Talaris document control system stay compliant with the current FDA and CFR regulations
- Oversees the maintenance of the document management system for Quality Documents
- Controls obsolescence of documents
- Maintenance of the physical and electronic systems for legacy quality documents
- Performs other job duties as assigned
Minimum Education, Training, and Experience Required:
- Bachelor’s degree
- 5+ years of quality assurance document control or equivalent experience required
- Experience with Veeva Electronic Document Management System (Quality Docs, Training, QMS)
- Knowledge of documentation control requirements for cell therapy/pharmaceutical industries
- Working knowledge of cGMP and regulatory requirements
- Solid knowledge of personal computer systems and desktop office applications, including Word, Excel, and PowerPoint
- Experience with key cGMP Quality Systems (e.g. Change management, Deviation, CAPA, Documentation)
- Excellent written and verbal communication skills; the ability to effectively write and edit comprehensive documents for a variety of audiences
- Proven ability to work effectively as a team member, including cross-functional teams.
- Proven ability to multitask, to organize and prioritize workload to meet deadlines and corporate objectives in a fast-paced environment
- Highly goal-driven approach and the ability to focus on time-sensitive objectives
- Must be able to work independently with minimal supervision
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This position involves sitting and / or standing for considerable lengths of time. Bending to floor level is required.
Essential Physical Job Tasks:
The physical demands described here are representative of those that must be met by an Associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires maintaining physical condition necessary for standing or sitting for prolonged periods of time; extensive use of computer keyboard. Lifting up to 20 lbs.
Must follow any applicable safety requirements.
Working conditions will be Heating Ventilation and Air Conditioned controlled.
- Health insurance
- Dental insurance
- Vision insurance
- Paid time off 25 days
- Stock Options
Apply: Please submit resume or CV and cover letter to hiring@Talaristx.com
Talaris is fully committed to equality of opportunity in all aspects of employment. It is the policy of Talaris to provide equal employment opportunity to all employees and applicants without regard to race, color, religion, national or ethnic origin, military status, veteran status, age, gender, gender identity or expression, sexual orientation, genetic information, physical or mental disability or any other protected status.