Quality Assurance Specialist – Product Quality
| Company | Ossium Health |
|---|---|
| Location | Indianapolis, IN, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Associate’s |
| Experience Level | Mid Level, Senior |
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
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
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