Quality Assurance Specialist, Product Quality

Ossium Health•Indianapolis, IN

3d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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
Review and approve Master Batch Records, validations, and other related documents
Promote a culture of quality and continuous improvement through actions and education
Track and trend data related to product quality
Support audits as needed