Quality Assurance Specialist

Company Details

US National Institutes of Health

Duties

As a GS-1910-12 Quality Assurance Specialist your duties may include but are not limited to the following:

  • Assisting with the development and implementation of a Quality Systems approach to manufacturing that is compliant with the FDA’s Drug Manufacturing Inspection Compliance Program which includes the Quality System and 5 manufacturing systems: Production System, Facilities and Equipment System, Laboratory Controls System, Materials System, Packaging and Labeling System and Quality System. Implements and monitors the CCE and DTM quality management program that promotes process excellence and is based on the Quality System Essentials (QSE) approach;
  • Administering the QA/I program in the CCE, including process control, document control, equipment validation, systems monitoring, document management, environmental monitoring, and personnel training and competency.
  • Leading quality improvement processes based on best practices; identifying opportunities for improvement and providing leadership with the initiation and implementation of projects to improve facility processes and meet customer needs;
  • Reviewing FDA cGMP and cGTP guidelines and communications for Cellular and Gene Therapies, Phase I/II Investigational Drugs and Human Cells, Tissues, and Cellular and Tissue Based Products, standards of the AABB, and current NIH -CC and DTM policies and procedures to assure manufacturing and testing of cellular therapy products processes are in compliance;
  • Drafting quality objectives with specific measurable activities and processes and quality assurance plans as needed for services performed;
  • Performing periodic “gap analysis” to identify and report gaps between policy and actual practice;
  • Collecting, tracking, and graphing pre-analytic, analytic, and post-analytic QA performance monitors. Identifying issues and trends and works towards resolution;
  • Ensuring there are mechanisms to monitor processes/systems that are considered to be critical to workplace safety; infection control; and safety and quality of the final products manufactured within a cGMP facility;
  • Drafting and revising CCE standard operating procedures (SOPs) and pertinent sections of the DTM Facility Drug Master File describing technical methods, procedures, forms, records and quality verification tasks supporting protocol-driven manufacture of cell therapy products;

As GS-1910-11 Quality Assurance Specialist, these duties are performed with less complexity and more supervision.

Requirements

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.
  • Males born after December 31, 1959 must be registered with the Selective Service.
  • If selected, you must pass a pre-employment medical examination.
  • This position is designated as an “emergency essential” position and the selected candidate will be considered an “emergency essential” employee.
  • Work environment involves regular and recurring exposure to infectious agents such as hepatitis and HIV and to noxious and flammable liquids such as xylene and formalin. Required to use protective clothing and this is a Bio hazard Level 2 facility.
  • The work requires regular and recurring physical exertion such as long periods of standing and walking, bending over instruments and microscopes, and lifting light to moderately heavy items such as reagents packs and various supplies.

Qualifications

GS-11
You qualify at the GS-11 level if you meet one of the following qualification requirements: One year of specialized experience equivalent to at least the GS-09 grade level in the Federal service obtained in either the private or public sector performing the following types of tasks: Provide support and assistance for a Cellular Therapy Quality Assurance(QA)/Inspection program including process control, document control, equipment validation, systems monitoring, document management, environmental monitoring, and personnel training and competency; reviewing manufacturing and testing of cellular therapy products processes to ensure compliance with FDA cGMP and cGTP guidelines and communications for Cellular and Gene Therapies, Phase I/II Investigational Drugs and Human Cells, Tissues, and Cellular and Tissue Based Products, and standards of the American Association for the Advancement of Blood and Biotherapies; assisting in the drafting and revising of standard operating procedures describing technical methods, procedures, forms, records and quality verification tasks supporting protocol-driven manufacture of cell therapy products; and assisting with the performance of quality audits performed by external and internal reviewers and also assisting in reviewing audit finding, following up with any necessary corrective and preventive actions and preparing responses as needed.


OR

Completion of a PhD degree in an accredited college or university; or 3 full years of progressively higher level graduate education leading to such a degree; or possession of a LLM degree, with a major study in quality assurance, statistics, mathematics, production management, industrial management, computer science, engineering, engineering technology, physical sciences, textiles, or other fields if related to the position.

OR

A combination of education and specialized experience that meets the qualification requirements for this position.

GS-12
You qualify at the GS-12 level if you meet the following qualification requirements: One year of specialized experience equivalent to at least the GS-11 grade level in the Federal service obtained in either the private or public sector performing the following types of tasks: Administering a Cellular Therapy Quality Assurance(QA)/Inspection program including process control, document control, equipment validation, systems monitoring, document management, environmental monitoring, and personnel training and competency; Assuring manufacturing and testing of cellular therapy products processes are in compliance with FDA cGMP and cGTP guidelines and communications for Cellular and Gene Therapies, Phase I/II Investigational Drugs and Human Cells, Tissues, and Cellular and Tissue Based Products, standards of the American Association for the Advancement of Blood and Biotherapies; drafting and revising standard operating procedures describing technical methods, procedures, forms, records and quality verification tasks supporting protocol-driven manufacture of cell therapy products; and assisting with the performance of quality audits performed by external and internal reviewers and reviewing audit finding, following up with any necessary corrective and preventive actions and preparing responses as needed.


Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position.

Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/11473677

Education

If you qualify based on education in lieu of specialized experience, you are strongly encouraged to submit a copy of your transcripts or a list of your courses including titles, credit hours completed and grades. Unofficial transcripts will be accepted in the application packages. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education.

Additional information

  • If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application.
  • This position is designated as an:”emergency essential” position and the selected candidate will be considered an “emergency essential” employee and will be required to be available, ready, willing, and able to report for duty under all circumstances (e.g., inclement weather, government closings and holidays, lapses in appropriations, non-emergency and emergency situations) for operation 24 hours a day and 365 days per year coverage.
  • Federal agencies may request information regarding the vaccination status of selected applicants for the purposes of implementing other workplace safety protocols, such as protocols related to masking, physical distancing, testing, travel, and quarantine. Employees providing healthcare or services in support of healthcare (Healthcare Workforce) may be required to receive a COVID-19 vaccine because they are expected to perform duties that put them in contact or potential contact with patients. We may request COVID-19 vaccination, and other vaccination documentation from Healthcare Workforce personnel at any point during the onboarding process or at any time during your employment with NIH.
  • A one-year probationary period may be required upon selection/placement.
  • PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration
  • We may make additional selections for similar positions within the commuting area(s) of the locations listed through this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s). Clearance of CTAP/ICTAP will be applied for similar positions.
  • The National Institutes of Health 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.
  • The NIH maintains a tobacco free work environment and campus.
  • Must be able to perform the essential duties of the position, with or without reasonable accommodation.
  • Visit our Applicant FAQs page for helpful information on the application process.
  • Visit our Total Compensation page for a detailed look into the benefits, awards, leave, retirement and other incentives employees may receive as part of a rewarding work environment.

  • Benefits

    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.

    Review our 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.

If you meet the minimum qualifications for this position, your application and responses to the online questionnaire will be evaluated under Category Rating and selection procedures for placement in one of the following categories:

  • Best Qualified – for those who are superior in the evaluation criteria
  • Well Qualified – for those who excel in the evaluation criteria
  • Qualified – for those who only meet the minimum qualification requirements

The Category Rating Process does not add veterans’ preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Applicants determined to be Best Qualified will be referred for further consideration. Preference eligibles in the Best Qualified category are referred before all other applicants.

To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings by the information you provide in your application. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as having knowledge of your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin prior to receiving an offer.

To be considered well qualified for the purposes of the Career Transition Assistance Program (CTAP) and the Interagency Career Transition Assistance Program (ICTAP), you must be able to satisfactorily perform the duties of the position upon entry and substantively exceed the basic qualifications by scoring at least an 85 on the assessment and meet all eligibility, physical, medical, suitability, and all other requirements.

  • Benefits

    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.

    Review our 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 Documents

    As a new or existing federal employee, you and your family may have access to a range of benefits. Your benefits depend on the type of position you have – whether you’re a permanent, part-time, temporary or an intermittent employee. You may be eligible for the following benefits, however, check with your agency to make sure you’re eligible under their policies.

    REQUIRED FOR ALL APPLICANTS
    RESUME:
    Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the “Qualifications” section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career.

    To ensure all of the essential information is in your resume, we encourage you to use the USAJOBS online Resume Builder. If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:

    • Job title
    • Name of employer
    • Beginning and ending dates of employment (month/day/year format)
    • Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
    • Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
    • Series and grade or equivalent (if a federal position)

    If the position has an education requirement or you are qualifying on the basis of education, you must list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.

    Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter.
    We will not access web pages linked on your resume or cover letter to determine your qualifications.

    For resume writing guidance, please visit the following resources: NIH Jobs website, USAJOBS Resource Center, and the USAJOBS Resume Writing Video Tutorial.

    ASSESSMENT QUESTIONNAIRE:

    You must submit a completed assessment questionnaire.

    Unless otherwise stated, we will only use the information above to determine your qualifications. Not providing the required information may result in a determination that you do not meet minimum requirements for the position (e.g., an ineligible rating) or a lower rating.

    REQUIRED DOCUMENTATION FOR PREFERENCE OR ELIGIBILITY CLAIMS

    To claim veterans’ preference, career transition selection priority, Schedule A or military spouse eligibility, you must provide the documentation listed below
    AND respond accordingly to the associated question on the online questionnaire.

    • Veterans’ preference (DD-214, VA Disability Letter, etc.): Reference Standard Form 15 (SF-15) for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point claims, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
    • Visit our sites on Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP) for more information and required documentation.
    • Visit our site on the Appointment of Certain Military Spouses for more information and required documentation to verify eligibility.
    • Schedule A Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under Schedule A must submit appropriate documentation to verify eligibility. Documentation must be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional’s letterhead and signed. Veterans’ preference takes precedence in these appointments.

    The Schedule A and military spouse hiring authorities do not guarantee employment or give an individual preference in the hiring process.

    If you do not provide the required information, we will assume you are not eligible, or you do not wish to be considered for any preference or eligibility.

    Do not submit documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official or hiring manager.

    If you are relying on your education to meet qualification requirements:

    Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

    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.

  • How to Apply

    To apply for this position, please read and follow all instructions in this announcement, complete the online application, and submit the documentation specified in the “Required Documents” section. Your complete application package must be submitted by 11:59 PM Eastern Time (ET) on 06/20/2022 to receive consideration.

    • To begin, click Apply to access the online application. You will need to be logged into your USAJOBS account to apply.
    • Follow the prompts to select your resume and/or other supporting documents to be included with your application package. See the “Required Documents” section for any additional forms and/or supplemental materials required.
    • Read all Eligibility questions and respond accordingly to any Eligibility you wish to claim. You will only be considered for those Eligibility questions (Status Applicant, Reinstatement, Schedule A, etc.) you respond in the affirmative to, regardless of what documentation you submit. We cannot assume you intended to respond differently to a question based on other information in your application package.
    • Complete the assessment questionnaire. Applicants are asked all questions regardless of their consideration preferences. We will only consider you for the grades, series, locations, specialties, and other considerations that you self-identify as being qualified for or interested in. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/11473677
    • Verify all required documentation is included in your application package, review your responses to the assessment questionnaire for accuracy, and then submit your application.

    In addition to the required documents,
    we encourage you to submit a cover letter, copy of your transcripts, and any applicable certifications or licenses. Even though this information is not required at the time of application, we may request this information later.

    We cannot assume responsibility or grant extensions for personal issues (e.g., troubles navigating the application process, loss of internet, not understanding a question) when applying to our announcements. For technical difficulties, contact HR Systems Support between 8:00 AM and 4:30 PM ET Monday through Friday at [email protected]

    If you need any other accommodation or assistance with applying, please contact Archer Mavin at [email protected] Requests for reasonable accommodations must be made before the announcement closing date.

    NIH’s EEO and Diversity and Inclusion Policy Statement

    Visit the NIH’s Office of Equity, Diversity, and Inclusion site for information on NIH’s EEO program, Reasonable accommodation procedures, laws, policy statements, and the operation of the EEO complaint process.

    Agency contact information

    Archer Mavin

    Address

    National Institutes of Health


    6701 Rockledge Dr


    Bethesda, MD 20892


    US

    Next steps

    Once you submit your application package, you will receive an acknowledgement email. You will be notified of the status of your applications via email. In addition, you can track the progress of your application package through your USAJOBS account.

    At the discretion of the agency, you may be contacted via phone or email for an interview or to provide additional information up to several months from the closing date of the announcement. Please ensure you have provided accurate contact information. To remain in consideration, you must respond in a timely manner to our correspondence and requests for documentation or information throughout the hiring process.

  • Fair and Transparent

    The Federal hiring process is setup to be fair and transparent. Please read the following guidance.

    • Equal Employment Opportunity (EEO) Policy
    • Reasonable accommodation policy
    • Financial suitability
    • Selective Service
    • New employee probationary period
    • Signature and false statements
    • Privacy Act
    • Social security number request

Required Documents

REQUIRED FOR ALL APPLICANTS
RESUME:
Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the “Qualifications” section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career.

To ensure all of the essential information is in your resume, we encourage you to use the USAJOBS online Resume Builder. If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:

  • Job title
  • Name of employer
  • Beginning and ending dates of employment (month/day/year format)
  • Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
  • Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
  • Series and grade or equivalent (if a federal position)

If the position has an education requirement or you are qualifying on the basis of education, you must list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.

Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter.
We will not access web pages linked on your resume or cover letter to determine your qualifications.

For resume writing guidance, please visit the following resources: NIH Jobs website, USAJOBS Resource Center, and the USAJOBS Resume Writing Video Tutorial.

ASSESSMENT QUESTIONNAIRE:

You must submit a completed assessment questionnaire.

Unless otherwise stated, we will only use the information above to determine your qualifications. Not providing the required information may result in a determination that you do not meet minimum requirements for the position (e.g., an ineligible rating) or a lower rating.

REQUIRED DOCUMENTATION FOR PREFERENCE OR ELIGIBILITY CLAIMS

To claim veterans’ preference, career transition selection priority, Schedule A or military spouse eligibility, you must provide the documentation listed below
AND respond accordingly to the associated question on the online questionnaire.

  • Veterans’ preference (DD-214, VA Disability Letter, etc.): Reference Standard Form 15 (SF-15) for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point claims, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
  • Visit our sites on Career Transition Assistance Program (CTAP)/Interagency Career Transition Assistance Program (ICTAP) for more information and required documentation.
  • Visit our site on the Appointment of Certain Military Spouses for more information and required documentation to verify eligibility.
  • Schedule A Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under Schedule A must submit appropriate documentation to verify eligibility. Documentation must be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional’s letterhead and signed. Veterans’ preference takes precedence in these appointments.

The Schedule A and military spouse hiring authorities do not guarantee employment or give an individual preference in the hiring process.

If you do not provide the required information, we will assume you are not eligible, or you do not wish to be considered for any preference or eligibility.

Do not submit documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official or hiring manager.

If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

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.

Help

This job is open to

  • Military spouses

  • The public

    U.S. Citizens, Nationals or those who owe allegiance to the U.S.

Clarification from the agency

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.

To apply for this job please visit www.indeed.com.

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