Quality Assurance Specialist III, Engineering

About the Job

Were 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.

Youll 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. Youll 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 youll 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

• Bachelors 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 Ossiums 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 youll 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