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Quality Assurance Specialist, Donor Quality

Ossium Health

Ossium Health

Quality Assurance
Indianapolis, IN, USA
Posted on Tuesday, June 6, 2023
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.