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Senior Quality Assurance Specialist

Position Title:   Sr. Quality Assurance Specialist

Reports to:       Director, Quality Assurance

Q32 Bio is advancing an innovative portfolio of immunomodulatory therapies. Using protein-based molecules, we aim to deliver life-changing treatments for patients for whom inadequate options exist.

Our dynamic, industry-experienced team is growing.  We seek an independent and highly motivated Sr Quality Assurance Specialist to join our energetic and collaborative team. Qualified candidates should be independent, hard-working and quality focused.


We are seeking a key individual to help develop our quality management system, execute Quality Operations activities, and to build a culture of quality throughout the organization.  This individual will will execute day to day .  This individual in this role will also be responsible for managing the portfolio of quality system validation projects based on corporate goals.

Key Responsibilities

  • Oversite and maintenance of Quality Management System (QMS) Tool
  • Develop, implement, and maintained Q32’s QMS system to support ongoing clinical development of new Drugs.
  • Maintain Q32’s electronic document management system.
  • Ensure adequate investigation and documentation of Quality Events
  • Oversee Change Control program and ensure full documentation of change actions
  • Oversee CAPA procedure, and ensure documentation and tracking of all CAPA actions.
  • Assist in establishing metrics and key performance indicators, and report regularly to executive leadership.
  • Work with subject matter experts to identify enhancements to business processes and system design, suggest solutions for implementation.


  • BS/BA in science related field with 3 + years of related Quality Assurance experience.
  • Knowledge of GLP, GMP, GCP, Part 11 regulations, FDA Guidance for Industry, EU regulations and regulatory requirements for computer system validation.
  • Working knowledge of Quality Management Systems.
  • Intermediate knowledge of Microsoft Office® applications including Excel, Word, Power Point, and Microsoft Project. This included items such as managing Word styles and constructing charts in Excell.
  • Strong problem solving and analytical skills.
  • Ability to think strategically and maintain attention to detail.
  • A problem solver able to interact at all levels of the organization.
  • Demonstrated ability to manage multiple priorities simultaneously and work effectively in a fast-paced environment.
  • Excellent written and verbal communication skills. Strong decision-making ability.

Interested candidates should send your resume to