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.
- 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 firstname.lastname@example.org.