Senior Quality Specialist
At PrognomiQ, we aim to develop and commercialize transformative tests for early detection and treatment of cancer and other complex diseases. To accomplish this, we are leveraging leading proteomics technology, including the Proteograph product suite from Seer Bio, in combination with other multi-omics assays to develop unprecedented molecular views of health and disease. We are a team of experienced and accomplished scientists supported by a group of leading investors in healthcare and technology.
Would you like to be at the leading edge of molecular data generation and analyses that changes how cancer and other complex diseases are detected and treated? Or are you looking to bring innovative and disruptive solutions to market? If you answer “yes” to either of these questions, let us know by applying!
The Senior Quality Specialist will help establish/maintain the Quality Management system in close partnership with the Director of Quality, manage the electronic document management system as well as support training, audits/inspections and continuous improvement. Focus will be on putting in place SOPs, coordinating training activities to ensure compliance to applicable procedures, standards and regulations. This position supports both R&D and Operations through all phases of product lifecycle.
- Work with Quality Director to define and implement the Quality Management System (QMS)
- Establish Quality System records and drive to completion
- Write, review and revise Standard Operating Procedures (SOPs)
- Review and control documents in accordance with document control procedures
- Partner with document originators to resolve discrepancies and compile required changes to documents
- Oversee document change control processes and drive to closure
- Conduct internal audits of the electronic document management system and documents (where needed) to ensure compliance to applicable Policies and SOPs
- Partner with functional leaders/managers to define training plans and ensure timely completion of all training assignments
- Coordinate the investigation and closure of complaints, CAPAs and NCRs
- Support both internal and external audits
- Compile and provide applicable metrics for periodic Management review
- Assist with other tasks within the Quality department
- BA/BS in Science
- 5 to 7 years’ experience in Quality Systems
- Understanding of Quality Management Systems (CAP/CLIA, 21 CFR 820) development, implementation, compliance, and audits
- Proficient technical writing skills and use of documentation programs (e.g., Office Windows, Excel, Access, Power Point, etc.)
- Must be able to manage multiple projects and report progress against goals in an objective manner
- Ability to thrive and flourish in a fast-paced growing start-up environment
Equal Opportunity Employment
PrognomiQ is an equal opportunity employer that celebrates diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other characteristic protected by law. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.