Quality Control Associate, Materials

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.

The Quality Control Associate, Materials is responsible for assessing and reviewing the quality systems used to evaluate if products are being processed in compliance with internal/external standards, regulations, contractual agreements, policies, and procedures. The Quality Control Associate, Materials must be able to continually adapt to the evolving regulatory landscape. This individual will report to the Quality Control Manager and work closely with members of the Quality Assurance and Supply Chain teams.

As a member of the quality control team, this position will be responsible for the inspection of in‑process and finished cell products and release of starting materials, along with the execution and monitoring of material inspections and assistance in the development or modification of internal systems.

• Bachelor of Science degree in Life Sciences discipline
• 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
• Demonstrated strong interpersonal skills including excellent communication skills and attention to detail
• Excellent written and oral communication skills
• Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
• Full‑time in our Indianapolis office, Monday through Friday, with occasional work from home on Fridays based on business needs
• 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

• 2+ years of work experience in either:
• An FDA regulated recovery, processing or testing facility
• Aseptic laboratory testing, microbial monitoring or cleanroom operations
• Strong computer skills including Microsoft Office and database applications

• Perform inspection and release of raw materials
• Perform inspection of in‑process and finished cell products
• Provide quality support by resolving raw material and in‑process material issues
• Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends regarding materials
• Perform and write deviations, nonconformances, and investigations as required
• Design, review and approve/reject batch‑related documentation, test methods, procedures and reports, and monitor all compliance to procedures escalating discrepancies
• Provide on‑the‑floor oversight in GMP cleanroom and laboratory environments and support to ensure compliance to GMP regulations throughout those areas
• Coordinate change controls and the documentation of the risk assessments, change documents, implementation of change, and objective evidence of the change in a compliant manner
• Capture metric information for use in continuous improvement of areas of responsibility and report to management, as needed
• Support regulatory filings through participation in data gathering

• Releasing raw materials for production of clinical products
• Developing and revising materials testing procedures
• Gathering data for continuous improvement and regulatory compliance

• 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

Ossium Health provides equal employment opportunities (EEO) to all employees and applicants for employment…