Biologics Quality Assurance Specialist

US-Agricultural-Research-Servic

Manhattan (KS)

On-site

USD 60,000 - 90,000

Full time

7 days ago

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Job summary

USDA Agricultural Research Service in Manhattan, KS seeks a quality assurance professional to coordinate the development and implementation of a laboratory QA management system for biologics and related regulated products.

The role involves collaborating with the Quality Assurance Manager and the Biologics Development Module Director, performing quality audits, maintaining SOPs, and ensuring compliance with ISO/GMP/GLP and biosafety standards.

Qualifications

Specialized experience implementing and maintaining a laboratory Quality Management System (QMS) for biologics or regulated products.
Experience performing quality audits and applying ISO/GMP/GLP and biosafety standards.
Ability to author/revise SOPs and quality documentation in high-containment or regulated laboratory settings.
Experience leading QMS implementation and continuous improvement with CAPAs and related metrics.

Responsibilities

Coordinate with the Quality Assurance Manager and Biologics Development Module Director to develop and implement a QA management system.
Ensure compliance with ISO/GLP/GMP and biosafety standards across regulated processes.
Maintain and revise SOPs and quality documentation to support regulatory readiness.