Quality Assurance Specialist III, Engineering

Ossium Health•Indianapolis, IN

11d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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