A Quality professional with proven track record in building, aligning and maintaining quality culture with a maniacal focus on patient experience and outcomes. Everything you do and say leads by example of how quality helps change people’s lives. You don’t see departments, you see individual architects shaking the foundation of science and medicine. If this is you, read on.
We are not married to specific tools, technologies or shiny objects. We ask questions until we arrive at the best answer to the patient. We believe glycoproteins are a new language of biology we are translating for the benefit of patients, researchers, science and medicine. We have diverse backgrounds and experiences, skeptical about the status quo yet solution oriented. If this sounds like a good fit, read on.
We are seeking a talented individual with a proven track record as our Quality Assurance Associate. The desired candidates would have experience in a regulated industry, building a quality culture into every aspect of the organization. Ensuring quality of work and patient centric acumen is a must.
- Manage document control process and act as system administrator for company’s electronic document management system
- Responsible for providing quality oversight to the change management system for change controls. This includes providing plan creation oversight, verifying the change adheres to internal procedures, regulatory requirements, and ensuring communication and escalation of potential issues of broader impact to the business
- Maintain and support development and implementation of company policies/procedures and ensure compliance and adherence to regulated QA activities for commercial operations
- Track and maintain quality metrics and report to management in specified frequency. Reporting to management areas of performance that are not improving with recommendations for next steps
- Participate in the internal, supplier audit programs and audits by outside agencies
- Participate in several LDT test development and launch activities
- Other duties as assigned
- BS in biological sciences, chemistry or analytical chemistry
- >5 years experience heading quality organizations
- Extensive experience in document control, change control, and validation of systems
- Experience in managing and validating electronic document management systems (EDMS) and/or product lifecycle management (PLM) is a must
- Operated in regulated environments
- A genuine desire to impact patient lives