Ossium Health deploys cellular therapeutics, bioengineering, and other regenerative medical tools to drive lasting gains in the health, vitality and longevity of human beings. We develop, process, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood and immune diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good.
About the Job
We’re looking for an experienced Compliance Specialist to support internal and external audits, to review and approve batch products, and to come in and own quality systems. The key responsibility for this role will be traveling to Organ Procurement Organizations (OPOs) on a regular basis to audit and ensure that our partners are meeting standards and requirements. By managing these you will have a big impact on our success as a company. As a part of the Compliance team, you’ll report directly to the Director of Compliance and work closely across all teams, suppliers, and customers to ensure that our products meet the highest standards of quality. We are constantly working to iterate on our approaches, and we are looking for someone who can bring their experience and ideas to the table to help us drive continuous improvement.
Bachelor of Science degree in Life Sciences or Chemistry
5+ years quality experience in an OPO or tissue/organ procurement, with at least 2 of those years in auditing
Experience in an FDA regulated recovery, processing or testing facility
Experience in aseptic laboratory testing, microbial monitoring or cleanroom operations
Capable of effectively assimilating information from visual inspection, written documents, and verbal inputs and identifying potential compliance risks
Hands-on experience with AATB standards
Demonstrated strong interpersonal skills including excellent communication skills
Willingness to travel up to 60% of time for audits
Strong computer skills including Microsoft Office
Capability to operate with a high level of organization, attention to detail, and excellent time management in a dynamic startup environment
Hands-on experience with CLIA and FACT standards
Perform, manage and track internal and external audits to ensure adherence with all requirements while monitoring corrective actions
Capture metric information for use in continuous improvement of areas of responsibility and report to management, as needed
Support regulatory filings through participation in data gathering for the annual product review process
Ossium is an Essential Healthcare Operations Business with continuous operations throughout the pandemic. This position involves work in a laboratory containing biological materials including human blood and tissues. Blood-borne pathogen training is required. New hires will be given the option of Hepatitis B vaccination. Other physical demands or requirements include:
• Reporting to Ossium’s Indianapolis laboratory during regular business hours
• Consistently adhering to Ossium’s safety protocols, including wearing appropriate PPE and implementing social distancing expectations on and off-site
• Working in a moderately noisy open-office environment
• Working in controlled environments requiring special gowning (i.e. over the head, face, hands, feet, and body)
• Being able to sit or stand for long periods of time
Ossium provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity or gender expression.
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About Ossium Health
Ossium’s mission is to improve human health through driving innovation in biotechnology that fosters the preservation of life.
Ossium develops and manufactures cell therapy products that cure leukemia and other blood cancers, improve organ transplantation, treat radiation poisoning, and heal tissue damage.
The cells of the immune system are the human body’s natural defenders against disease. At Ossium, we are developing better methods of recovering, preserving, and deploying these critical cells to keep disease at bay.