Quality Assurance Specialist, Batch Review

About the Job

We’re hiring a Quality Assurance Specialist to focus on Product Quality and uphold compliance with internal/external standards, regulations, policies, and procedures. This individual will review production and testing records related to the production of bone marrow and bone marrow derived products, ultimately signing off on the Quality Assurance (QA) release of the product for clinical applications. In this role, you will work closely with other departments to identify deficiencies, deviations, and improvement opportunities. 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 Associate Supervisor, Product Quality.

Required Qualifications

• 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 Qualifications

• 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

Key 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

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

• Review Production and Quality Control records and work with the departments to correct errors 
• Perform the QA release of clinical product so that it can be used as a life-saving treatment
• Learn about Production and Quality Control activities to identify areas of improvement

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