Biological Scientist

About the role

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,

What you will do

• 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.

Education

Please see above for education qualification requirement information.

How you will be evaluated

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. To view the application form, visit: ***

Documents you must provide

• 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; Work Experience 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.

What to expect next

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 ***, subject line: Fair Chance Act.

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.