Biological Scientist
Job Location:
Manhattan, IL - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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
- Maintain current knowledge of International Organization for Standardization standards World Organization for Animal Health and Good Manufacturing Practice/Good Laboratory Practices regulations and integrate these requirements into SOPs/practices.
- Maintain current knowledge of American Association of Veterinary Laboratory Diagnosticians (AAVLD) CVB policies and integrate these requirements into Standard Operating Procedures (SOPs) and practices.
- Plan administer and evaluate quality compliance program; initiate audits/inspections; and coordinate corrective actions to mitigate identified risks.
- Develop document and manage a Quality Management System (QMS) aligning with quality programs and all applicable laws and regulations.
- Monitor QMS effectiveness using QMS software observations and periodic reviews; contribute to internal Quality Assurance (QA) audits and management review reports.
- Develop prepare review and interpret quality policies SOPs and program documents; guide authors/reviewers to meet QMS and facility documentation standards.
- Gather calculate and collate quality performance metrics; prepare reports that evaluate functionality efficiency and accountability.
- You must be a US Citizen or US National.
- Males born after 12/31/1959 must be Selective Service registered or exempt.
- Subject to satisfactory adjudication of background investigation and/or fingerprint check.
- Successful completion of one-year probationary period unless previously served. Refer to the Next Steps section for more information.
- Direct Deposit: Per Public Law 104-134 all Federal employees are required to have federal payments made by direct deposit to their financial institution.
- Successfully pass the E-Verify employment verification check. To learn more about E-Verify including your rights and responsibilities visit E-Verify at Motor Vehicle or Commercial Drivers License required.
- Drug Test Required.
- Vaccine(s) Required.
- Special Physical Requirements/Demands (May wear full encapsulated suit).
- SAC and full background investigation required for positions working with BSL-3 (or higher) agents or in BSL-3/BSL-4 facilities.
- Department of Justice (DOJ) Security Risk Assessment (SRA) approval is required.
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-11 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.
Please see above for education qualification requirement information.
Career Transition Assistance Plan (CTAP) Reemployment Priority List (RPL) or Interagency Career Transition Assistance Plan (ICTAP): Visit the OPM website for information on how to apply as a CTAP RPL or ICTAP eligible. To exercise selection priority for this vacancy CTAP/RPL/ICTAP candidates must meet the basic eligibility requirements and all selective factors. CTAP/ICTAP candidates must be rated and determined to be well qualified (or above) based on an evaluation of the competencies listed in the How You Will Be Evaluated section. When assessed through a score-based category rating method CTAP/ICTAP applicants must receive a rating of at least 85 out of a possible 100.
The Office of Personnel Management has granted Direct Hire Authority for Scientific Technical Engineering and Mathematics (STEM) positions. There is a critical hiring need and these positions play a critical role within the USDA.
The USDA has authority to recruit and fill Permanent (Career/Career-Conditional) positions under Direct Hire Authority. Under this authority any U.S. citizen may apply.
For more information on the Government-wide Direct Hire Authority positions click here
Recruitment or Relocation Incentive may be authorized. The final determination to pay an incentive will be made by the hiring official at the time of job offer.
This is a Testing Designated Position (TDP). Selectee must submit to a urinalysis to screen for illegal drug use prior to appointment and random testing thereafter. Final appointment and continued employment is conditional on negative results for illegal drug use.
Other Considerations:
- The health status of personnel is monitored periodically using biologic and serologic tests and physical examinations.
- Restrictions against contact with birds and livestock outside the laboratory may apply after entering high security animal facilities that are working with disease agents foreign to the United States.
This position may be eligible to telework up to four days per week based upon the duties of the position. This position may also be eligible for flexible work arrangements as determined by agency policy and any applicable collective bargaining agreements.
Candidates should be committed to improving the efficiency of the Federal government passionate about the ideals of our American republic and committed to upholding the rule of law and the United States Constitution.
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
Required Experience:
IC
