Donor Operations Associate
Donor Operations Associate at OpenBiome
OpenBiome is the world's first stool bank—a nonprofit organization that is expanding safe access to Fecal Microbiota Transplantation (FMT) and driving groundbreaking clinical research on the human microbiome.
Since launching in 2013 out of MIT, our stool banking service has redefined the standard of care for an emerging field of medicine. When we began, only a handful of clinicians offered FMT, a treatment that has an 85% cure rate for C. difficile, the most common hospital-acquired infection in the country. Today we support FMT programs at over 1,000 medical centers across all 50 states. OpenBiome has delivered more than 35,000 treatments for recurrent C. difficile infection, radically improving the lives of thousands of patients that lack treatment alternatives.
OpenBiome has also emerged as a leading independent research organization. We have developed a pill formulation for FMT, published more than 20 scholarly works and enabled the launch of 30 clinical trials in indications spanning autoimmune disease, infectious disease, malnutrition, metabolic disease, and obesity, and neuropsychiatric disease, to identify opportunities for microbiome-based health interventions. The research that we enable is at the vanguard of understanding how the microbes in our bodies shape major public health challenges.
The Donor Operations Associate will be responsible for assisting in the development of systems and procedures for the Stool Donor Program, and for investigating and responding to quality events and nonconformities. Additionally, this role will function to ensure that Donor Operations meets company, local, state, and national regulatory standards to comply with GCP, IRB, FDA, ICH, Finch QA, and MA Department of Public Health standards.
Position Responsibilities / Duties:
• Serve as liaison with Quality Assurance to meet company and regulatory standards
• Author and revise SOPs
• Manage and track SOP development, training and implementation in MasterControl
• Serve as the lead investigator for quality deviations and nonconformities in Donor Operations, and work with other team members to write reports
• Initiate or assist in the generation of CAPAs
• Assist in developing and improving systems for GxP activities in Donor Operations
• Ensure compliance with the Donor Management Quality Standard, and update as needed
• Communicate with the Institutional Review Board to file annual reports, submit amendments, ask clarifying questions, and report major/minor deviations from protocol.
• Maintain controlled documentation (donor records, SOPs, regulatory filings)
• Assist in maintaining the integrity of all electronic and hard copy donor records
Skills, Knowledge, Qualifications, and Experience:
• Bachelor’s or Associate’s Degree, plus 1-3 years of professional experience
• Interest in building systems and problem solving
• Strong verbal and written communication
• Experience managing and tracking projects
• Exceptional attention to detail and ability to multi-task
Reporting to this position: N/A
OpenBiome is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, status as a qualified individual with disability, or any other legally protected status. All applicants must be able to show proof of eligibility to work in the United States.