Ossium Health · 1 month ago
Quality Assurance Specialist, Product Quality
Greater Indianapolis
Full-time
Onsite
Senior Level
5+ years expOssium Health is dedicated to improving health through bioengineering and cell therapy products. They are seeking a Quality Assurance Specialist to ensure product quality and compliance with standards, working closely with various departments to identify and resolve issues related to the production of bone marrow products.
BiotechnologyHealth CareLife Science
No H1B
Responsibilities
Review technical production and testing records and identify deviations, non-conformances, and compliance issues
Work across departments to resolve issues and implement improvements
Coordinate and communicate effectively with impacted stakeholders
Sign off on QA release of product for clinical applications
Promote a culture of quality and continuous improvement through actions and education
Track and trend data related to product quality
Support audits as needed
Qualification
Required
Associates degree in Life Sciences/Chemistry and 5+ years of experience in Quality
Ability to complete tasks and projects with little oversight
Capable of effectively assimilating information from visual inspection, written documents, and verbal inputs and identifying potential compliance risks
High level of professionalism and good judgment
Strong computer skills, including Microsoft Office
Excellent written and oral communication skills
Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
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
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
Preferred
Bachelor's Degree in Life Sciences/Chemistry
Experience in tissue, organ or cell industry
Understanding of 21 CFR 210, 21 CFR 211, 21 CFR 1271, AATB Standards, and other GMP requirements
Familiarity with and previous experience working with Master Control, preferably in the Production Records module
Benefits
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
Company
Ossium Health
Ossium Health builds a bone marrow bank to treat blood cancers.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$128.87MKey Investors
California Institute for Regenerative Medicine
2023-07-25Series C· $52M
2023-04-28Grant· $3.46M
2021-03-18Series B· $63M
Leadership Team
Susannah Cantrell
Chief Commercial Officer
Recent News
Morningstar.com
2026-01-23
Longevity.Technology
2026-01-14
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