Biological Scientist

US-Agricultural-Research-Servic; Manhattan (KS); On-site; USD 60,000 - 90,000; Full time

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.

Skills

Quality Assurance

QMS

Auditing

SOPs

Regulatory standards

Biosafety

Quality documentation

Education

Biological sciences / related field

Ph.D. in biology / related field

Tools

ISO/GLP/GMP standards

Job description

This position is in the Quality and Select Agent Program Management Unit. Their mission is to ensure the highest standards of NBAF operations, regulatory Biologics Development Module compliance, and ARS scientific integrity.

The incumbent coordinates with the Quality Assurance Manager and the Biologics Development Module Director to develop and implement a quality assurance management system consisting of specific policies/processes/procedures involving the technological transfer of vaccines,

Applicants must meet all qualifications and eligibility requirements by the closing date of the announcement including specialized experience and/or education, as defined below.

Basic Requirements for Biologics Series, 0401:

Degree: Biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. Related degree may include genetics.

OR

A combination of education and experience: Specifically, you must have courses equivalent to a major, as shown above, plus appropriate experience or additional education.

AND

In addition to meeting the basic education requirements described above, applicants must also meet additional qualification requirements as stated below:

FOR THE GS-11:

Applicants must demonstrate at least one full year of specialized experience equivalent to at least the GS-09 grade level in the Federal service. The specialized experience requirements for the GS-11 is fulfilled by having experience implementing and maintaining a laboratory Quality Management System (QMS) for biologics or comparable regulated products; performing quality audits; applying International Organization for Standardization standards (ISO)/Good Manufacturing Practice/Good Laboratory Practices (GMP/GLP) and biosafety standards; and authoring/revising SOPs and quality documentation in a high-containment or regulated laboratory setting.

OR

Education: You must have a Ph.D. or equivalent doctoral degree in biology, genetics, computational biology, bioinformatics, statistics, or a directly related field. Related degree may include chemistry.

OR

A combination of doctorate-level education and specialized experience as described above.

FOR THE GS-12:

Applicants must demonstrate at least one full year of specialized experience equivalent to at least the GS-12 grade level in the Federal service. The specialized experience requirements for the GS-12 is fulfilled by having experience leading implementation and continuous improvement of a laboratory quality Management System (QMS) for biologics or comparable regulated products; conducting quality audits; applying ISO/GLP/GMP and biosafety standards; authoring/controlling SOPs and quality documentation; and using quality metrics and risk assessments to drive Corrective and Preventive Actions (CAPAs) in a high-containment or regulated laboratory environment.

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.