Biologics QA Scientist - Quality & Compliance Lead

US Department of Agriculture (USDA) Agricultural Research Service (ARS); Manhattan (KS); On-site; USD 80,000 - 110,000; Full time

Job summary

The Agricultural Research Service (ARS) is seeking a qualified candidate to support the NBAF Quality and Select Agent Program Management Unit in advancing a comprehensive quality assurance management system. This role focuses on ensuring top-tier operations, regulatory compliance, and scientific integrity across the biologics program.

You will collaborate with the Quality Assurance Manager and the Biologics Development Module Director to develop and implement policies and procedures governing

Qualifications

• Degree or education/experience combination as described for Biologics.
• GS-11 requires 1 year of specialized experience in QMS, audits, ISO/GMP/GLP, biosafety, SOPs.
• GS-12 requires leadership of QMS improvements, audits, SOPs, CAPAs in regulated labs.

Responsibilities

• Develop and implement a quality assurance management system.
• Coordinate with QA Manager and BD Module Director on quality policies.
• Ensure compliance with ISO/GLP/GMP and biosafety standards in a high-containment setting.

Skills

Quality management

Quality audits

SOP development

Regulatory compliance

Education

Biological sciences / related

Job description

The Agricultural Research Service (ARS) is seeking a qualified candidate to support the NBAF Quality and Select Agent Program Management Unit in advancing a comprehensive quality assurance management system. This role focuses on ensuring top-tier operations, regulatory compliance, and scientific integrity across the biologics program.

You will collaborate with the Quality Assurance Manager and the Biologics Development Module Director to develop and implement policies and procedures governing