Quality Assurance Specialist

Role Summary

We are seeking a highly motivated individual to join Soleno Therapeutics supporting Quality Systems. Responsibilities primarily include the oversight of Soleno’s Document Control and Training Systems.

Responsibilities

• Maintain the GxP Document Control and Training systems.
• Process document change controls and training records.
• Provide formatting support on controlled documents using Microsoft suite (e.g., Word, Excel).
• Maintains hard copy files and electronic files of GxP records.
• Participates in developing and improving Standard Operating Procedures to ensure quality objectives are met.
• Assist in quality systems and compliance activities, including but not limited to supplier quality, audit management, inspection readiness, internal audit, deviations, change controls and CAPAs.
• Foster a quality culture that values innovation, continuous improvement, and personal accountability. Support GxP systems and process improvement initiatives.
• May work on assignments and other duties to support Quality Systems where judgement is required in resolving problems and making recommendations.
• Keeps abreast of requirements for compliance in own area of work. Participates as required in training on regulatory issues affecting own area of work. Notifies Manager of compliance questions and issues.

Qualifications

• Minimum of 3-5 years of relevant experience in Quality (Document Control) in the pharmaceutical/biotech industry or equivalent combination.
• Previous experience using an eQMS system is required.
• Demonstrates proficiency in Microsoft Office suite (e.g., Word, Excel).
• Knowledgeable of current regulatory guidance, including GxPs.
• Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Responsible and self-motivated with effective time management, organizational, and planning skills.

Education

• Bachelor’s Degree in a scientific discipline.