Quality Control Associate
- Somerville , MA
- September 6, 2019
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Quality Control 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 50,000 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 Control (QC) Associate, with guidance from the Quality Control Supervisor, will perform specimen sampling and testing as defined by laboratory management to meet demands of production, method development, validation, stability or other ad hoc requests. Additionally, the Associate will support the development of QC systems to improve and/or maintain the state of control in the manufacturing facility.
Position Responsibilities / Duties
- Maintain a high level of personal compliance to the required standards.
- Inspect incoming lots of in-process materials for conformance with applicable specifications.
- Coordinate third-party testing and review and report data to identified stakeholders in a timely manner.
- Collect and process samples in a timely manner.
- Perform testing of raw materials, in-process materials and final products in accordance with SOPs and applicable regulations.
- Perform cGMP Documentation Review.
- Support equipment calibration/monitoring program.
- Participate in writing and revising SOPs, Test Methods, Work Instructions, Event Reports, and other documents as identified / assigned.
- Assist in the development and optimization of testing methods.
- Ensure the QC lab is compliant, clean, and properly stocked.
- Document thorough investigations following OOS / unexpected results.
- Participate in the qualification of equipment, methods, and processes.
- Complete required paperwork and documentation in a timely manner.
- Support and/or conduct investigations into unexpected events.
- Actively participate in meetings.
- Understand and support implementation of Change controls, CAPAs, and other modes of continuous improvement.
- Notify laboratory manager of any deviations or issues and initiates incident investigations as required.
Skills, Knowledge, Qualifications, and Experience
- Minimum of Bachelor’s Degree (or international equivalent), preferably in Life Sciences.
- 0-2 years of professional experience, preferably in a regulated industry; experience working in a GMP lab environment is a plus
- Proficiency in Microsoft Office
- Ability to work independently with limited 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.