Quality Assurance Associate II
Quality Assurance Associate II 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 Quality Assurance Associate II, with guidance from the Senior Manager of Quality Assurance, will support day to day Quality operations by providing quality support and guidance to Biomanufacturing (BM) and Donor Operations staff and performing a variety of complex tasks under general guidance to ensure continued compliance to cGxPs.
Position Responsibilities / Duties:
- Perform documentation issuing (batch records, logbooks, lab note books).
- Facilitate the lifecycle of controlled documents (document creation revision, and obsoleting).
- Perform batch record review, disposition and final unit releases.
- Perform review and release of incoming raw materials.
- Perform Log Sheet review (logbooks, autoclave, cleaning, disinfection, room usage, etc.).
- Create and revise SOP’s, Forms, Material Specifications and Batch Records.
- Initiate, review and approve change controls.
- Track and maintain the Event Reporting system (manual and electronic).
- Initiate, review and approve deviation investigations.
- Perform event report investigations as required.
- Administer training for investigational writing and Root Cause Analysis.
- Track open CAPA's and follow up to ensure CAPA requirements are met.
- Perform daily GMP area walkthroughs.
- Participate in internal audits and follow up on recommendations to ensure requirements are met.
- Support Quality Director in Regulatory and Compliance audits.
- Other duties as assigned.
- Maintain the effectiveness of the Quality System.
- Maintain a high level of personal compliance to the required standards.
- Exercise professional written and verbal communications skills in supporting customer and team member needs.
- Assist Senior Manager of Quality Assurance and Director in mapping and designing key quality processes.
- Contributor on cross functional project teams.
- Identify and present opportunities for process improvements.
- Maintain training in all applicable SOP’s and Regulatory Requirements.
- Participate appropriately in all company initiatives including promoting a safe work environment and supporting 5S activities.
- Other duties as assigned.
Skills, Knowledge, Qualifications, and Experience:
- Minimum of Bachelor’s Degree (or international equivalent), preferably in Life Sciences.
- 3+ years of experience in a regulated environment, with 2+ years of QA experience.
- Ability to identify aberrant data and potential quality/compliance concerns escalating to management.
- Well organized, solid multitask abilities and must be able to perform under pressure/meet deadlines.
- Good technical writing skills.
- Proficient in MS Office applications.
- Ability to work independently, with minimal supervision.
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.