About Ossium
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’re hiring a Quality Assurance Specialist III, Engineering to partner closely with Equipment and Facilities and ensure quality is embedded into day-to-day operations. Embedded within Engineering and reporting through Quality, this role helps teams operate compliantly, efficiently, and without silos.
You’ll support daily operations and issue resolution while helping the organization meet its goals and maintain compliance through investigations, CAPAs, management of change, qualification and validation activities, and procedure management. You’ll translate regulatory requirements into practical, risk-based solutions in a hands-on, highly collaborative role with regular floor presence and strong cross-functional interaction.
As a trusted quality partner, you’ll coach teams, strengthen quality systems, and help prevent issues before they occur while supporting audit readiness, compliance, and continuous improvement across the organization. This position reports to the Director, Quality Assurance.
Required Qualifications
- Bachelor’s degree in Life Sciences, Engineering, or a related field
- 4+ years of experience in FDA-regulated industries (biotech, pharmaceuticals, cell/gene therapy preferred)
- Strong working knowledge of FDA regulations and quality systems
- Experience with investigations, CAPA, change control, and equipment qualification
- Excellent written and verbal communication skills, including technical writing
- Strong analytical and problem-solving skills
- Ability to work cross-functionally and influence without direct authority
- Capability to operate with a high level of organization and time management in a dynamic startup environment
- Qualified candidates must be legally authorized to be employed in the United States; Ossium is unable to provide sponsorship for employment visa status (eg, H-1B or TN status) for this position, either now or in the future
- This position is based on site in our Indianapolis office; employees will report to Ossium’s facility Monday through Thursday and have the option to work remotely on Fridays
Preferred Qualifications
- Experience in HCT/Ps, tissue banking, cell therapy, or biologics
- Experience with cGTP, GMP, and AATB
- Familiarity with electronic QMS platforms (e.g., MasterControl)
- Experience scaling processes in high-growth environments
Key Responsibilities
- Partner with Equipment and Facilities to embed quality into daily operations
- Champion a culture of quality, accountability, and continuous improvement
- Support and lead investigations, deviations, and CAPAs, ensuring effective root cause analysis
- Manage and support management of change activities
- Review and approve quality documentation, including events, deviations, CAPAs, change controls, and procedures
- Support equipment and facility qualification and validation activities
- Monitor operations for quality issues, trends, and risks and escalate as needed
- Provide real-time floor support and quality guidance to resolve issues
- Support internal and external audits and maintain audit readiness
- Serve as a liaison between Quality, Equipment, Facilities, and cross-functional partners
In your first six months some projects you’ll work on include:
- Taking ownership of Equipment and Facilities-related events, deviations, investigations, CAPAs, and change
- Building strong working relationships with Engineering, Facilities, and Quality partners
- Supporting equipment and facility qualification and validation activities
- Identifying trends, risks, and improvement opportunities within Engineering quality systems
- Helping strengthen audit readiness and cross-functional quality alignment
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