Quality Control Supervisor
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Job Description

Quality Control Supervisor at OpenBiomeĀ 

Quality Control Supervisor 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 45,000 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.

Position Summary:

The Quality Control (QC) Supervisor, with guidance from the Associate Director of Quality Control, will support manufacturing activities by coordinating the reporting of lab-generated data as it pertains to lot release and stability studies. The QC Supervisor will both contribute to and iterate strategic planning initiatives regarding process improvements across all QC systems. This individual will communicate with professionalism and clarity both internally and across groups to support the integration of a company-wide understanding of Quality Control. Additionally, he/ she will focus on process improvement to the existing systems as well as executing on deviations, CC, CAPAs, invalid assays, and OOS results.  

Position Responsibilities / Duties:

  • Maintain a high level of personal compliance to the required standards 
  • Supervise and Train QC associates
  • Represent Quality as the Safety Officer. Including improving and developing appropriate safety programs and trainings.
  • Develop and improve the Quality Control Retain system
  • Develop and improve the method performance monitoring system
  • Coordinate testing with external laboratories and ensure adherence to release testing and timelines
  • Manage QC related communications and relationships with CTOs
  • Review executed test records and generate Certificate of Analysis (CoA).
  • Lead method transfers, qualifications, and validations.
  • Ensure appropriate qualification of laboratory equipment
  • Perform data analysis and trending of data in support of monitoring and method life-cycle programs 
  • Provide strategic technical guidance and support for all QC operations in relation to quality systems (e.g. change controls, CAPA, deviations, etc.)
  • Support and perform when necessary routine testing of raw materials, in-process materials and final products in accordance with SOPs and applicable regulations
  • Ensure that samples are processed in a timely manner
  • Ensure log books related to inventory and equipment are maintained
  • Ensure labs are clean and safe (in compliance with cGMP) and properly stocked
  • Represent QC during safety and operational lab audits
  • Participate in writing and revising SOPs, Test Methods, and other technical documents
  • Make detailed observations in support of Alert, Action and OOS result investigations
  • Provide strategic /technical guidance and support for all stability operations and related quality systems (change controls, CAPA, deviations, etc.)
  • Participate in writing and revising SOPs and Protocols
  • Assist in regulatory submissions and responses
  • Assist in lab space planning and build out

Skills, Knowledge, Qualifications, and Experience:

  • Bachelor's degree in microbiology (preferred), or related field
  • At least 5 years of Quality Control experience
  • Familiarity with relevant and current FDA, EU, ICH guidelines and regulations
  • Preferred candidate should have 2 years’ experience in managing staff and or project work, and mentorship of junior staff
  • Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment
  • Self-starter, detail-oriented, data-driven, and a team player
  • Be flexible and excited to work in a fast-paced environment with evolving needs 

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.


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.