Quality Assurance Document Specialist

Job Title:              QA Document Specialist
Schedule:              Full-time
Location:              Louisville, KY
Reports to:            Manager, Quality Assurance
Direct Reports:      None

Talaris Therapeutics, Inc.(“Talaris”) is developing a breakthrough, one-time cell therapy to enable patients who receive a living donor kidney transplant to no longer require lifelong immunosuppression, without rejecting their donated organ.  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 2008 – 2016, our lead therapy, FCR001, enabled 70% of patients to be weaned off all immunosuppression within 12 months of their kidney transplant. No tolerized patient has had to resume immunosuppression.  We have followed these patients for an average of almost five years since their transplant, and the longest for over ten years.  Our single-dose cell therapy has also shown the potential to induce durable remission of certain types of severe auto-immune diseases, and to benefit other solid organ transplant patients.  Talaris has announced a $100M private financing from leading life sciences investors and has initiated a Phase 3 pivotal trial of our therapy in living donor kidney transplant patients.  We also expect to initiate two Phase 2 trials of our therapy in additional indications in 2020.  Our cell processing facility and most of our operations are based in Louisville, KY, and we also have a corporate office in Boston, MA.

Job Description

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 an archival of QMS, CMC, Clinical, Preclinical Toxicology, 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. In this role you will also be responsible for maintaining, updating, and enforcing the company’s good documentation policies.

Primary responsibilities:

  • Coordinates and manages regulatory submissions documents, including IND, BLA, IMPD, NDA, and MAA filings, Letters to File, and will assist in the coordination and management of various briefing books, meeting minutes and essential regulatory documents.
  • Maintains an archive of essential documents, including, but not limited to training matrices and records, version control aspects, changes, and annual review of protocols, reports, SOPs, investigations, and specifications.
  • Maintains and continuously improves document control system and SOPs per FDA regulation standards requirements.
  • Generate/present QA reports as needed and coordinate data for management review.
  • Maintain record integrity by archiving and retrieving of record
  • Must be able to work independently and lead projects
  • Oversee the maintenance of the document management system for Quality Records master drawings, CO’s, Specifications, SOPs, etc., as required.
  • Controls obsolescence of documents.
  • Excellent written and verbal communication skills; the ability to effectively write and edit comprehensive documents for a variety of audiences.
  • Excellent interpersonal skills with a proven track record of building and maintaining strong relationships with internal and external stakeholders.
  • 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.
  • Proven organizational skills and attention to detail with a focus on accuracy and quality.

Minimum Requirements

  • Thorough knowledge of all aspects of training, documentation control and Change processes.
  • Aptitude for detail, accuracy and excellent organizational skills, knowledge of PC based programs such a: Microsoft Word, Excel and data input.
  • Ability to identify, and resolve problems, and handle multiple assignments.
  • Great and proven communications skills.

Apply: Please submit resume or CV and cover letter to hiring@Talaristx.com

Talaris is an equal opportunity employer and prohibits unlawful discrimination.