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Ossium Health · 3 weeks ago

Quality Assurance Specialist, Product Quality

Greater Indianapolis

Full-time

Onsite

Senior Level

5+ years exp

Ossium Health is dedicated to improving health through bioengineering and cell therapy products. They are seeking a Quality Assurance Specialist to ensure compliance with standards and regulations while reviewing production and testing records related to bone marrow products.

BiotechnologyHealth CareLife Science

Growth Opportunities

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

Qualification

Quality AssuranceLife Sciences/ChemistryGMP requirementsMaster ControlMicrosoft OfficeProfessionalismWritten communicationOral communicationTime management

Required

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