Quality Assurance Specialist
Watertown, MA Quality Assurance
Job Type
Full-time
Description

  

Lyra Therapeutics (Nasdaq: LYRA) is a clinical-stage company pioneering a new therapeutic approach to treat debilitating ear, nose and throat (ENT) diseases that impact the lives of millions of people. Our goal is to transform the ENT treatment paradigm by providing effective front-line solutions for physicians and new treatment options for their patients. In a Phase 1 study, the company observed a rapid, clinically meaningful and durable improvement in symptom score, with 90% of Chronic Rhinosinusitis (CRS) patients having improved symptoms at 24 weeks. A positive Phase 2 study readout of LYR-210 for the treatment of chronic rhinosinusitis with and without nasal polypsis was recently announced and LYR-220 is expected in the clinic next year. Headquartered in the Boston area, Lyra Therapeutics was founded by George Whitesides and Robert Langer, academic luminaries in the fields of chemistry, materials science and biotechnology. 


Our Quality team is growing and we are seeking a Quality Assurance Specialist to provide Quality oversight for Manufacturing and Quality Operations, including documentation review of executed Quality records. The Specialist will also assist in the development, implementation, and maintenance of quality systems and other Quality Assurance activities.  Reporting to the Director of Quality Assurance, this role will be critical in supporting the growing needs of our internal and external manufacturing at Lyra Therapeutics. 


Key Areas of Responsibility:

  • Partner with the members of QA, QC and Manufacturing in batch production activities providing quality guidance of quality issues
  • Attend and participate in Quality Meetings
  • Responsible for escalation of quality deficiencies identified in the production process
  • Maintains and monitors key quality systems such as: deviations, investigations, CAPA; which includes the review of trended data to identify areas for improvement
  • Review Batch records, deviations, investigations, documents, validation protocols, and reports compliance to internal and GMP standards
  • Write and revise master specification and inspection records
  • Review and approve raw material and component testing for manufacturing. 
  • Support manufacturing with line clearance
  • Write and revise Standard Operating Procedures (SOPs) and applicable policies as required
  • Interacts with personnel from all departments of Lyra Therapeutics to ensure GMP compliance
  • Performs reviews of internal and external batch documentation, records and reports
  • Review QC data generated as to the acceptance to established product specifications
  • Perform lot disposition activities for intermediate sub-assemblies and finished product
  • Provide guidance and support with resolution of investigations and CAPA’s
  • Interact with contractor personnel or consultants regarding validation and qualification activities
  • Assist in the scheduling and maintenance of Quality Assurance activities and systems.
  • Support material management from and to external GMP warehouse
  • Review and analyze environmental monitoring reports and determine corrective actions for excursions
Requirements

  

  • BS in a scientific discipline or equivalent with a minimum of 7 years’ experience in an FDA regulated industry or MS in a scientific discipline or equivalent with a minimum of 5 years’ experience in an FDA regulated industry
  • Experience with Quality Assurance oversight and support for all phases of clinical trials
  • Demonstrate confidence in knowledge of Good Manufacturing Practice (GMP) regulations.
  • Demonstrate attention-to-detail, problem solving, and ability to make decisions quickly
  • Demonstrated ability to effectively organize and execute tasks. Strong verbal and written communication (including presentation) and CMO/ CRO management skills
  • Knowledge and previous experience with GMP, 21CFR Part 210- 211, 21CFR part 4, and 21 CFR Part 11
  • Ability to work independently and in a team environment
  • Ability to positively resolve conflict
  • Flexibility for changes in work priorities
  • Experience working in cross functional teams and managing the relationships and expectations of several key stakeholders
  • Experience working collaboratively with CMO’s (Contract Manufacturing Organizations) 

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.