QA Document Control Associate
Description

Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases. Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery. LYR-210 is designed for surgically naïve patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial.  These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year. For more information, please visit www.lyratherapeutics.com and follow us on LinkedIn and Twitter.


We currently have an opening for a Quality Assurance Associate - Document Control with experience in document control and records management, as well as general knowledge of biopharmaceutical manufacturing.  The ideal candidate will have a good understanding of cGMP and safety standards, and must thrive in a fast-paced and highly dynamic setting.  The QA Document Control Associate will work with departments to plan, develop, author, edit, format, illustrate, update, and create documents, including SOPs, logbooks, job aids, etc.  This role will interface closely with cross-functional groups such as Operations, Facilities, Engineering, Quality Control, and Management.


Responsibilities

  • Manage document control program and workflows in both paper-based system and electronic Document Management System (eDMS) to ensure documents are managed through the controlled document lifecycle in accordance with established procedures
  • Coordinate cross-functional reviews and approvals to meet project timelines
  • Provide end user training on eDMS and other systems within the scope of job responsibilities
  • Create and modify user accounts and administer training program in eDMS according to established procedures
  • Compile metrics for document control to identify areas for quality system improvements 
  • Ensure documents meet formatting and template requirements
  • Issue GxP documents and labels
  • Maintain and organize GxP documentation in high density filing room and manage GxP documentation tracking, reconciliation, and archival
  • Provide documentation support during client audits and regulatory inspections
  • Author or revise SOPs related to document control, as needed
  • Generate and distribute meeting minutes for routine quality system meetings
  • Assists with the improvement of quality compliance by identifying recurring issues and trends 
  • Manage incoming requests to QA department by resolving independently or elevating to senior QA personnel
Requirements
  • Bachelor’s degree in Life Sciences discipline preferred
  • A minimum of 2 years’ experience in Quality Assurance or related field
  • Ability to take direction, work independently, manage time, and effectively interact with various groups and personnel·  Experience with eDMS system and GxP documentation
  • Strong skills with common computer software such as Microsoft Office (Word, Excel, PowerPoint) 

At Lyra, we value creativity, leadership, and collaboration.  The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable.  We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team.  For consideration, please submit cover letter and CV.

Please visit www.lyratx.com for more information.