Ossium’s mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good.
About the Job
We are looking for an experienced Auditor to support internal and external American Association of Tissue Banks (AATB), 21 CFR Part 1271, and Current Good Tissue Practices (CGTP) compliance. This individual will report to the Senior Manager, Quality Systems and will work closely across teams internally and partners externally to ensure that our products meet the highest standards of quality. A key responsibility will be to manage our tissue recovery partner qualification and verification process to ensure that our partners are meeting standards and requirements. Additionally, you will be responsible for managing internal audits and making recommendations to ensure quality of tissue products and readiness for AATB, FDA, and state inspections. Ossium’s quality system is 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.
Required Qualifications
- Bachelor of Science degree in Life Sciences or Chemistry
- 5+ years quality experience in tissue procurement or processing, with at least 2 of those years in auditing
- Experience working in or auditing an AATB accredited and FDA regulated recovery, processing, or distribution facility
- Capable of effectively assimilating information from visual inspection, written documents, and verbal inputs to identify potential compliance risks
- Demonstrated strong interpersonal skills including excellent communication skills
- Strong computer skills including electronic quality management systems, Microsoft Office, and document sharing and storage platforms
- Capability to operate with a high level of organization, attention to detail, and excellent time management in a dynamic startup environment
- Willingness to travel up to 40% of time for on-site audits
- This position is based on-site in our Indianapolis facility
Preferred Qualifications
- CQA Certification
- Hands-on experience with CGMP, CLIA, and FACT standards
- Experience working in or auditing cell therapy product manufacturing facilities
Key Responsibilities
- Qualify and monitor new and existing recovery partners
- Distribute and evaluate recovery partner surveys to develop and implement audit schedules based on risk
- Perform, manage, and track internal and external audits to ensure adherence with all requirements while monitoring corrective actions and providing recommendations
- Suggest improvements and identify gaps in internal processes to ensure compliance with AATB, FDA, and state and federal laws
- Document all activities within the electronic quality system
- Manage and improve internal policies and procedures related to auditing
Physical Requirements
- Reporting to Ossium’s Indianapolis laboratory during regular business hours, if not traveling
- Working in a moderately noisy open-office environment
- Working in controlled environments requiring special gowning as required for audits (e.g., over the head, face, hands, feet, and body)
- Being able to sit or stand for long periods of time
We offer a full slate of employee benefits including:
- Competitive salaries
- Stock options
- 401(k) matching
- Medical, dental and vision coverage
- Four weeks of PTO accrued (vacation & sick time) annually + 11 company holidays
- Employer paid life insurance and long term disability
- Gym membership/recreational sports reimbursements