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,
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,
Applications will be accepted from any U.S. citizen. Direct Hire Authority will be used to fill this position. Veterans Preference and traditional rating and ranking of applicants does not apply to this vacancy.
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.
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 https://www.e-verify.gov/.
Valid Motor Vehicle or Commercial Driver's 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.
Qualifications
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.
Education
Please see above for education qualification requirement information.
Additional 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.
If you are selected for a position with further promotion potential, you will be placed under a career development plan, and may be non-competitively promoted if you successfully complete the requirements and if recommended by management. However, promotion is neither implied nor guaranteed.
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.
How you will be evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
Due to the Direct-Hire Authority (DHA), applicants are not rated and ranked numerically, and
Veteran's preference does not apply. Applicants are strongly encouraged to provide complete
information about their job-related experience and education. Your resume must document that you
meet the Qualification Requirements detailed above. Applicants who meet the minimum qualification
requirements established for the position will be placed in the Eligible category. Although Veteran's
preference does not apply due to the existence of the DHA for this position, applicants are still
encouraged to provide documentation related to veteran's preference.
Applications will be evaluated in accordance with Office of Personnel Management's (OPM) Delegated Examining Procedures and USDA policy. You will be evaluated based on how well you meet the qualifications listed in this vacancy announcement. Your qualifications will be evaluated based on your application materials (e.g., resume, supporting documents), your responses on the application questionnaire, and your responses to all assessments required for this position.
You will be assessed on the following competencies (knowledge, skills, abilities, and other
characteristics):
Attention to Detail
Decision Making
Flexibility
Integrity/Honesty
Interpersonal Skills
Learning
Reading Comprehension
Reasoning
Self-Management
Stress Tolerance
Teamwork
The USA Hire Assessment includes a cut score based on the minimum level of required proficiency in these critical general competencies. You must meet or exceed the cut score to be considered. You will not be considered for the position if you score below the cut score or fail to complete the assessment.
Your application, including the online Assessment Questionnaire, will be reviewed to determine if you meet (a) minimum qualification requirements and (b) the resume supports the answers provided to the job-specific questions. Your resume must clearly support your responses to all the questions addressing experience and education relevant to this position. Those determined to be qualified will be referred to the selecting official for consideration.
Note: If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and or experience, your score may be adjusted to more accurately reflect your abilities, or you may be found ineligible. Please follow all instructions carefully. Errors or omissions may affect your rating. Providing inaccurate information on Federal documents could be grounds for non-selection or disciplinary action up to including removal from the Federal service.
Clicking the link below will present a preview of the application form; i.e. the online questionnaire. The application form link below will only provide a preview and does not initiate the application process. To initiate the online application process, click the "Apply" button to the right.
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.
The following documents are required for your applicant package to be complete. Our office cannot be responsible for incompatible software, your system failure, etc. Encrypted documents will not be accepted. Failure to submit required, legible documents may result in loss of consideration.
Resume that includes:Personal Information: name, address, contact information; Education; WorkExperience related to this position as described in the major duties including work schedule, hours worked per week, dates of employment; title, series, grade (if applicable); other qualifications. Resume cannot exceed 2 pages.
If education is required or you are using education to qualify, you must submit a copy of your college transcripts. An unofficial copy is sufficient with the application if it includes your name and the necessary course information; however, if you are selected, you will be required to submit official transcripts prior to entering on duty. Education must have been successfully obtained from an accredited school, college or university. If any education was completed at a foreign institute, you must submit with your application evidence that the institute was appropriately accredited by an accrediting body recognized by the U.S. Department of Education as equivalent to U.S. education standards. There are private organizations that specialize in this evaluation and a fee is normally associated with this service. For a list of private organizations that evaluate education, visit the NACES website. All transcripts must be in English or include an English translation.
If claiming veteran's preference, you must submit a DD214, Certificate of Release from Active Duty, which shows dates of service and discharge under honorable conditions. If currently on active duty you must submit a certification of expected discharge or release from active duty service under honorable conditions not later than 120 days after the date the certification is submitted. Veteran's preference must be verified prior to appointment. Without this documentation, you will not receive veteran's preference and your application will be evaluated based on the material(s) submitted.
If claiming 10-point veteran's preference you must provide the DD214 or certification requirements (see above bullet), plus the proof of entitlement of this preference as listed on the SF-15 Application for 10-point Veterans' Preference. The SF-15 should be included but is not required. Failure to submit these documents could result in the determination that there is insufficient documentation to support your claim for 10-point preference. For more information on veterans' preference visit FEDSHIREVETS
Surplus or displaced employees eligible for CTAP, RPL, or ICTAP priority must provide: proof of eligibility (RIF separation notice, notice of proposed removal for declining a transfer of function or directed reassignment to another commuting area, notice of disability annuity termination), SF-50 documenting separation (as applicable), and your most recent SF-50 noting position, grade level, and duty location with your application per 5 CFR 330.
If you are relying on your education to meet qualification requirements:
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
Please read the entire announcement and all instructions before you begin. You must complete this application process and submit all required documents electronically by 11:59p.m. Eastern Time (ET) on the closing date of this announcement.
Applying online is highly encouraged. We are available to assist you during business hours (normally 8:00a.m. - 4:00p.m., Monday - Friday). If applying online poses a hardship, contact the Agency Contact listed below well before the closing date for an alternate method. All hardship application packages must be complete and submitted no later than noon ET on the closing date of the announcement to be entered into the system prior to its closing. Resumes must not exceed two pages.
This agency provides reasonable accommodation to applicants with disabilities on a case-by-case basis; contact the Agency Contact to request this.
To begin, click "Apply" and follow the instructions to complete the Assessment Questionnaire and attach your resume and all required documents.
Please verify that documents you are uploading from USAJOBs transfer into the Agency's staffing system as there is a limitation to the number of documents that can be transferred. However, once in the Agency's staffing system, you will have the opportunity to upload additional documents. Uploaded documents must be less than 5MB and in one of the following document formats: GIF, JPG, JPEG, PNG, RTF, PDF, TXT or Word (DOC or DOCX). Do not upload Adobe Portfolio documents because they are not viewable. Please ensure your resume does not exceed two pages. Applicants who submit a resume that exceeds two pages will be removed from consideration.
Agricultural Research Service
2150 Centre Avenue
Building D, Suite 300
Fort Collins, CO 80526
US
Next steps
As a condition of employment for accepting this position, you will be required to serve a 1-year probationary period during which we will evaluate your fitness and whether your continued employment advances the public interest. In determining if your employment advances the public interest, we may consider: your performance and conduct; the needs and interests of the agency; whether your continued employment would advance organizational goals of the agency or the Government; and whether your continued employment would advance the efficiency of the Federal service. Upon completion of your probationary period your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest.
Your application will be reviewed to verify that you meet the eligibility and qualification requirements for the position prior to issuing referral lists to the selecting official. If further evaluation or interviews are required, you will be contacted. Log in to your USAJOBS account to check your application status.
You must choose to turn on email notifications in your USAJOBS profile if you want to receive important email notifications that may impact your applicant experience (e.g. If you start an application and do not submit it prior to the closing date, USAJOBS will send an email reminder that the closing date is approaching and your application is in an incomplete status).
Multiple positions may be filled from this announcement.
Under the Fair Chance Act, agencies are not allowed to request information about an applicant's criminal history until a conditional offer of employment has been made, except as allowed for access to classified information; assignment to national security duties or positions; acceptance or retention in the armed forces; or recruitment of a Federal law enforcement officer. An applicant may submit a complaint or any other information related to an organization's alleged noncompliance with the Fair Chance Act. The complaint must be submitted within 30 calendar days of the date of the alleged noncompliance. To make a Fair Chance Act inquiry or complaint, send an email with the appropriate information to Rachel.Amroliwalla@usda.gov, subject line: Fair Chance Act.
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
The following documents are required for your applicant package to be complete. Our office cannot be responsible for incompatible software, your system failure, etc. Encrypted documents will not be accepted. Failure to submit required, legible documents may result in loss of consideration.
Resume that includes:Personal Information: name, address, contact information; Education; WorkExperience related to this position as described in the major duties including work schedule, hours worked per week, dates of employment; title, series, grade (if applicable); other qualifications. Resume cannot exceed 2 pages.
If education is required or you are using education to qualify, you must submit a copy of your college transcripts. An unofficial copy is sufficient with the application if it includes your name and the necessary course information; however, if you are selected, you will be required to submit official transcripts prior to entering on duty. Education must have been successfully obtained from an accredited school, college or university. If any education was completed at a foreign institute, you must submit with your application evidence that the institute was appropriately accredited by an accrediting body recognized by the U.S. Department of Education as equivalent to U.S. education standards. There are private organizations that specialize in this evaluation and a fee is normally associated with this service. For a list of private organizations that evaluate education, visit the NACES website. All transcripts must be in English or include an English translation.
If claiming veteran's preference, you must submit a DD214, Certificate of Release from Active Duty, which shows dates of service and discharge under honorable conditions. If currently on active duty you must submit a certification of expected discharge or release from active duty service under honorable conditions not later than 120 days after the date the certification is submitted. Veteran's preference must be verified prior to appointment. Without this documentation, you will not receive veteran's preference and your application will be evaluated based on the material(s) submitted.
If claiming 10-point veteran's preference you must provide the DD214 or certification requirements (see above bullet), plus the proof of entitlement of this preference as listed on the SF-15 Application for 10-point Veterans' Preference. The SF-15 should be included but is not required. Failure to submit these documents could result in the determination that there is insufficient documentation to support your claim for 10-point preference. For more information on veterans' preference visit FEDSHIREVETS
Surplus or displaced employees eligible for CTAP, RPL, or ICTAP priority must provide: proof of eligibility (RIF separation notice, notice of proposed removal for declining a transfer of function or directed reassignment to another commuting area, notice of disability annuity termination), SF-50 documenting separation (as applicable), and your most recent SF-50 noting position, grade level, and duty location with your application per 5 CFR 330.
If you are relying on your education to meet qualification requirements:
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
Please read the entire announcement and all instructions before you begin. You must complete this application process and submit all required documents electronically by 11:59p.m. Eastern Time (ET) on the closing date of this announcement.
Applying online is highly encouraged. We are available to assist you during business hours (normally 8:00a.m. - 4:00p.m., Monday - Friday). If applying online poses a hardship, contact the Agency Contact listed below well before the closing date for an alternate method. All hardship application packages must be complete and submitted no later than noon ET on the closing date of the announcement to be entered into the system prior to its closing. Resumes must not exceed two pages.
This agency provides reasonable accommodation to applicants with disabilities on a case-by-case basis; contact the Agency Contact to request this.
To begin, click "Apply" and follow the instructions to complete the Assessment Questionnaire and attach your resume and all required documents.
Please verify that documents you are uploading from USAJOBs transfer into the Agency's staffing system as there is a limitation to the number of documents that can be transferred. However, once in the Agency's staffing system, you will have the opportunity to upload additional documents. Uploaded documents must be less than 5MB and in one of the following document formats: GIF, JPG, JPEG, PNG, RTF, PDF, TXT or Word (DOC or DOCX). Do not upload Adobe Portfolio documents because they are not viewable. Please ensure your resume does not exceed two pages. Applicants who submit a resume that exceeds two pages will be removed from consideration.
Agricultural Research Service
2150 Centre Avenue
Building D, Suite 300
Fort Collins, CO 80526
US
Next steps
As a condition of employment for accepting this position, you will be required to serve a 1-year probationary period during which we will evaluate your fitness and whether your continued employment advances the public interest. In determining if your employment advances the public interest, we may consider: your performance and conduct; the needs and interests of the agency; whether your continued employment would advance organizational goals of the agency or the Government; and whether your continued employment would advance the efficiency of the Federal service. Upon completion of your probationary period your employment will be terminated unless you receive certification, in writing, that your continued employment advances the public interest.
Your application will be reviewed to verify that you meet the eligibility and qualification requirements for the position prior to issuing referral lists to the selecting official. If further evaluation or interviews are required, you will be contacted. Log in to your USAJOBS account to check your application status.
You must choose to turn on email notifications in your USAJOBS profile if you want to receive important email notifications that may impact your applicant experience (e.g. If you start an application and do not submit it prior to the closing date, USAJOBS will send an email reminder that the closing date is approaching and your application is in an incomplete status).
Multiple positions may be filled from this announcement.
Under the Fair Chance Act, agencies are not allowed to request information about an applicant's criminal history until a conditional offer of employment has been made, except as allowed for access to classified information; assignment to national security duties or positions; acceptance or retention in the armed forces; or recruitment of a Federal law enforcement officer. An applicant may submit a complaint or any other information related to an organization's alleged noncompliance with the Fair Chance Act. The complaint must be submitted within 30 calendar days of the date of the alleged noncompliance. To make a Fair Chance Act inquiry or complaint, send an email with the appropriate information to Rachel.Amroliwalla@usda.gov, subject line: Fair Chance Act.
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
