Akouos is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company focused on developing gene therapies with the potential to restore, improve and preserve high-acuity physiologic hearing for people worldwide who live with disabling hearing loss.
Restoring, improving and preserving high-acuity hearing is an area of high unmet need in medicine: 466 million people worldwide have disabling hearing loss, and there are no FDA-approved therapies to address its underlying causes.
Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy. Listening is in our DNA. We believe the only way to achieve our ambitious goals is to engage as one team, listen to each other, and trust in ourselves and our science.
We are looking for a GMP Quality Operations Specialist to join our organization to support our Quality Operations Team. The Quality Operations Specialist is an important position that supports ongoing quality assurance responsibilities in support of the manufacture, testing, and release of product. The incumbent is expected to support evaluating deviations, change controls, and disposition of clinical drug product. The Quality Operations Specialist is responsible for ensuring reviews of Manufacturing and Quality Control/Assurance records are certified for compliance to in-house specifications/standards and Good Manufacturing Practices for all Akouos products. In addition, they will work with the Quality Systems Team to identify key continuous improvement opportunities to ensure quality systems are aligned with Akouos business strategy, industry standards, and global regulatory expectations. The Quality Operations Specialist will participate in departmental or cross-functional teams and activities to ensure completion of projects while adhering to budget, scope and schedule requirements.
- Reviews manufacturing and support records to certify compliance with specifications and procedures
- Makes recommendations to Quality Assurance Management for the release of product based on Quality Assurance record review and approval
- Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, on the floor walk through activities of the facility, and deviation issues
- Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending
- Reviews and approves Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
- Interacts professionally with company management, internal departments, and other sites to effectively implement and maintain Quality Systems
- Representing Quality Assurance at various project and technical meetings, as needed
- Working with all departments to ensure timely completion of Deviations, CAPA, Change Controls, Investigations, and Environmental Excursions
- Inputting information from the Quality Systems into electronic databases and generating reports from these systems
- Capturing and reporting metrics around Quality System and Batch Record review turnaround times and closure/approval times
- Providing on the floor support to Manufacturing
- Reviewing Manufacturing batch records and completing required documentation for batch disposition
- Document creation and review, including Standard Operating Procedures, protocols, and reports
- Performing Internal Audits and Data Audits, as needed
- Providing training to site personnel and contractors on GMP and the Quality System procedures
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Bachelor’s degree in Life Sciences, or related field or with 5 to 8 years’ experience in biopharmaceutical/pharmaceutical or related industry with at least 3 years direct quality experience
- Excellent written and verbal communication and negotiating skills
- Experience with complex biologic products, such as gene and/or cell therapies, is preferred
- Ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment
- Ability to monitor and report on assigned tasks, goals, and objectives
- Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors