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 and immune 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 to focus on Donor Quality and uphold compliance with internal/external standards, regulations, policies, and procedures. Specifically, this Specialist will perform and manage reviews of recovery partner donor records, including the follow-up activities required to complete the chart audit. In this role, you’ll be responsible for the initiation and completion of nonconformance reports, creation and maintenance of request lists related to donor records, managing recovery partner correspondence and notifications, donor chart reviews, consultation with Medical Director, release of product related to Medical Director review of donor records, and determination of donor eligibility. Additionally, you’ll be responsible for the execution and monitoring of various quality systems as well as assisting in the development and modification of internal systems to ensure that Ossium products maintain the highest standards of quality and safety.

This position reports to our Supervisor, Quality Assurance.

Required Qualifications

Associates degree in Life Sciences/Chemistry and 5+ years of experience in Quality
Experience in reviewing medical records and understanding of medical terminology
Experience in an FDA regulated recovery, processing, or testing facility
Experience in aseptic laboratory testing, microbial monitoring, or cleanroom operations
Capable of effectively assimilating information from visual inspection, written documents, and verbal inputs and identifying potential compliance risks
Comprehensive knowledge on application of tools, concepts and methodologies of quality systems such as ISO, FDA, CLIA, AABB
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 full-time in our Indianapolis office

Preferred Qualifications

Bachelor's Degree in Life Sciences/Chemistry
Experience in tissue, organ or cell industry
Experience in AATB and/or FACT certified facilities
Familiarity with and previous experience working with Master Control

Key Responsibilities

Perform, manage, and track quality assessments of donor records to ensure timely reviews and adherence with all standards, regulations, and requirements
Review documents across various systems to verify compliance
Participate in the continuous improvement of department databases, workflows
Review and maintain compliance with quality procedures
Maintain knowledge on all required regulations
Update job knowledge by participating in educational opportunities, reading professional publications, maintaining personal networks, participating in professional organizations
Enhance quality department and Ossium Health’s reputation by accepting ownership for accomplishing new and different requests

In your first six months some projects you’ll work on include:

Establishing relationships and taking over as the primary point of Ossium QA contact for multiple recovery agencies nationwide
Shadowing the QA Supervisor on Recovery Partner audits to gain familiarity with the process
Diving deep into our Quality Management System Master Control to learn the modules and understand the workflow

Physical Requirements

This position involves work in a facility containing biological materials including human blood and tissues. Blood-borne pathogen training is required, and new hires will be given the option of Hepatitis B vaccination.
Other physical demands or requirements include:
Reporting to Ossium’s facility during regular business hours
Consistently adhering to Ossium’s safety protocols, including wearing appropriate PPE
Moderately noisy open-office environment
Must be able to sit or stand for long periods of time

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

Ossium provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity or gender expression. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

Average Compensation: $118,529

How Much Do Ossium Health Employees Make?

High-paying Jobs at Ossium Health