Title 21 Vacancy Announcement

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Center for Biologics Evaluation and Research (CBER)

Office of Compliance and Biologics Quality (OCBQ)

Division of Manufacturing and Products Quality (DMPQ)

Application Period: 01/22/2024 – 02/11/2024

Area of Consideration: Public

United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal 

permanent residents are not eligible for consideration.

Position: Quality Assurance Specialist*

*Multiple selections can be made from this announcement

Series: 1910

Location(s): White Oak Campus, Silver Spring, MD. 241450031

Work Schedule: Full Time

Salary: Starting at $117,962

Cures Band(s): Band C Telework Eligible: Yes

Full Performance Band Level: Band C

Travel Requirements: Less than 25%

Bargaining Unit: 3591

Note: Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign 

a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an 

incentive will be offered and paid. Incentives include the following: moving expenses, recruitment, or relocation incentive; student loan 

repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed 

military service, etc.

This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures 

Act. The candidate selected for this position will serve under a career or career-conditional appointment and be 

paid under the provisions of this authority. Additional information on 21st Century Cures Act can be found here:

21st Century Cures Act Information

Introduction

The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer 

protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food 

additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and 

effective.

The Center for Biologics Evaluation and Research (CBER) is a Center within FDA that regulates biological products 

for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, 

and Cosmetic Act. CBER’s mission is to protect and enhance the public health through the regulation of biological 

and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. CBER protects 

and advances the public health by ensuring that biological products are safe, effective, and available to those who 
need them. CBER also provides the public with information to promote the safe and appropriate use of biological 

products.

Duties/Responsibilities

The incumbent serves as the Quality Assurance Specialist in the Division of Manufacturing and Products Quality 

(DMPQ) under the Office of Biologics Quality (OCBQ) within CBER. The Quality Assurance Specialist assists in 

facilitating the continual improvement of DMPQ’s role in the CBER managed review process by applying quality 

management tools per FDA SMG 2020 “Quality System Framework for Internal Activities.” 

Specifically, the Quality Assurance Specialist will: 

➢ Serve as an auditor of regulatory submission documentation and review time frames under Prescription 

Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA) regulations, and ensures that 

reviews are consistent with current regulations, guidelines, and CBER SOPPs;

➢ Coordinate and prepare responses and comments on guidance documents, policy statements, and 

procedures;

➢ Support the efficiency and effectiveness of DMPQ’s role within the CBER managed review process;

➢ Develop, implement and manage a training program for the reviewers and inspectors in DMPQ which 

entails a thorough understanding of manufacturing of biologics, manufacturing facility design, 

manufacturing equipment qualification; sterilization validation and aseptic processing as well as 

knowledge of current good manufacturing practices and biologics or drug inspections.

➢ Generate training materials and provide training;

➢ Audit reviews and inspections for technical accuracy and ensure that recommendations are consistent 

with the applicable regulations, guidelines, and CBER procedures;

➢ Support the planning, organizing, implementation and maintenance of a Center-wide quality system for 

review activities that ensures CBER’s production of quality work products and offers clear guidelines and 

quality standards for internal business activities;

➢ Assist with the development of innovative solutions along with implementing instructions for affecting 

changes involving new methodology, policies, or procedures;

➢ Write, revise, audit, manage and archive division procedures;

➢ Review and evaluate the results of analyses conducted under appropriate business standards on topics 

such as management reviews, documentation, managed review activities, reporting, IT and records 

management infrastructure, training, and other applicable quality system management programs;

➢ Provide advice and assistance to each office in implementing necessary programs and preparing 

associated documentation;

➢ Perform other duties as assigned.

Conditions of Employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.

• Employment is subject to the successful completion of a background investigation, verification of 

qualifications, completion of onboarding forms, submission of required documents, and any other job-related 

requirement before or after appointment.

• Applicants must meet all qualification requirements by the closing date of this announcement.

• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank 

account with a financial institution of your choice.

• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed 

through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative 

steps to resolve the matter.

• Males born after December 31, 1959 must be registered with the Selective Service.

• One year probationary period may be required. 

• Financial Disclosure may be required.

• Ethics Clearance may be required. 

• Background Investigation/Security Clearance is required. All employees must pass a security investigation. 

Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject 
to additional investigations at a later time. 

Qualifications

To be placed into a Cures position, candidates must meet the following criteria:

1. Scientific, Technical, and Professional Fields

2. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic 

requirements defined in the OPM Qualification Standards as a baseline for comparing experience 

levels and other candidate attributes for relevant positions.

b. Outstanding candidates can be defined by existing outstanding work experience, outstanding 

performance rating, or both.

In order to qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. 

Please note: Additional education and experience listed that is not indicated as required is preferable and desired. 

Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.

Education Requirement: Candidates must possess the required individual occupational requirements to qualify for 

the appropriate series applicable to the position. Please use the following link to determine the series for which 

you qualify: OPM Occupational Series Qualification Requirements

Desired Professional Experience: Knowledge of biologics or drugs manufacturing, and current good manufacturing 

practices (cGMP). Knowledge on training programs and procedures development.

Education Transcripts

SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific 

educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the 

Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar 

position or are a current FDA employee, you are not exempt from transcript requirements.

FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the 

qualification requirements, you must show that the education credentials have been evaluated by a private 

organization that specializes in interpretation of foreign education programs and such education has been deemed 

equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a 

U.S. accredited college or university. For more information about this requirement, please visit the U.S. 

Department of Education website for Foreign Education Evaluation.

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: Background Investigation/Security Clearance is 

required. All employees must pass a security investigation. Failing to pass the background check may be grounds 

for removal or legal action. If hired, you may be subject to additional investigations at a later time. 

Ethics Clearance Requirements

This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest 

regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek 

additional information on this requirement from the hiring official before accepting any job offers. For more 

information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. 

Equal Employment Opportunity 

The United States Government does not discriminate in employment on the basis of race, color, religion, sex 

(including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, 

disability, genetic information, age, membership in an employee organization, retaliation, parental status, military 

service, or other non-merit factor. Equal Employment Opportunity (EEO) for federal employees & job applicants
Reasonable Accommodation

Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. 

Applicants requiring reasonable accommodation for any part of the application process should follow the 

instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should 

contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a 

case-by-case basis. A reasonable accommodation is any change to a job, the work environment, or the way things 

are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal 

access to job benefits. Under the Rehabilitation Act of 1973, federal agencies must provide reasonable 

accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to 

apply for a job. An employee with a disability needs an accommodation to perform the essential job duties or to 

gain access to the workplace. An employee with a disability needs an accommodation to receive equal access to 

benefits, such as details, training, and office-sponsored events. You can request a reasonable accommodation at 

any time during the application or hiring process or while on the job. Requests are considered on a case-by-case 

basis. Learn more about disability employment and reasonable accommodations or how to contact an agency.

E-Verify

The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility Verification Program 

(E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social 

Security numbers.

How to Apply

Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using 

month and year training completed, in addition to describing duties performed during that time period), a copy of 

your unofficial transcripts, SF50 (if applicable), latest PMAP (if applicable), and letter of interest with “CURES 

CBER/OCBQ/DMPQ/Quality Assurance Specialist” in the subject line to: CBERHumanCapital@fda.hhs.gov. 

Applications will be accepted through 02/11/2024.

Announcement Contact

For questions regarding this Cures position, please contact CBERHumanCapital@fda.hhs.gov.

The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.

FDA is an equal opportunity employer.