Quality Assurance Specialist
Job Location:
Atlanta, GA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
This position is located in the Department of Health and Human Services Administration for Strategic Preparedness and Response headquartered in Washington District of Columbia.
This announcement will close at 11:59 PM on the day that 100 applications have been received or the closing date of the announcement whichever comes first.
As a(n) Quality Assurance Specialist you will:
- Perform duties required to ensure that the SNS maintains a comprehensive quality control program and that cGMP standards and other regulatory guidelines are adhered to by SNS staff and contract partners during the receipt storage handling transport and shipping preparation of pharmaceutical products.
- Conduct regular inspections of SNS facilities to document cGMP compliance and identify deficiencies; reviews facility data and documentation including but not limited to equipment validations document control system temperature monitoring product cold chain deviations corrective and preventive actions (CAPAs) and preventive maintenance.
- Review and recommend modification as necessary of the criteria for testing and validating temperature monitoring equipment computerized systems cold-storage units and other equipment required under cGMP for the maintenance of pharmaceutical products to ensure data is valid and reliable and cannot be manipulated.
- Participate in ongoing analyses and tracking/trending of events in support of the cGMP Quality Systems.
- U.S. Citizenship required
- Males born after December 31 1959 must be registered or exempt from Selective Service -
- Suitable for federal employment
- Meet time in grade restrictions by the closing date of the announcement
- Appointment will be subject to the applicants successful completion of a background security investigation and favorable adjudication. All information concerning qualifications is subject to investigation.
- Documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS E-Verify System.
- All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choice.
- All qualification requirements must be met by the closing date.
- Financial disclosure statement may be required.
- Probationary (or trial) period may be required.
WHAT WE ARE LOOKING FOR
Basic Qualifications:
Undergraduate and Graduate Education: Major study -- quality assurance statistics mathematics production management industrial management computer science engineering engineering technology physical sciences textiles or other fields related to the position.
or
Specialized Experience (for positions above GS-5): Experience that demonstrated a practical knowledge in monitoring controlling or maintaining the quality of products or services in quality assurance procurement inspection production or related areas. Examples include:
- Reviewing production activities and capabilities in light of contract quality requirements.
- Reviewing written quality or inspection procedures for adequacy and evaluating the implementation and effectiveness of quality/inspection systems including sampling plans.
- Analyzing quality data to detect unsatisfactory trends or weaknesses in the quality/inspection system.
- Verifying by test or inspection using sampling inspection or intensive product inspection techniques that products comply with requirements prior to acceptance.
- Identifying inadequacies and requesting corrective action.
- Computing data summarizing results and preparing reports or charts depicting pertinent relationships using statistical methods.
- Investigating customer complaints and deficiency reports and providing identification of causes to appropriate authorities.
- Reading interpreting and applying technical data such as blueprints engineering drawings product specifications or technical manuals.
- Reviewing and evaluating supply systems operations and procedures through periodic audits and surveillance inspections.
Minimum Qualifications: You must have one year specialized experience to perform successfully the duties of the position. To be creditable specialized experience must have been equivalent to at least the GS-11 grade level in the Federal service performing ALL of the following:
- Managing product inspection and compliance for medical countermeasures products such as vaccines therapeutics etc.
- Interpreting and applying Current Good Manufacturing Practice (cGMP) regulations and guidance.
- Implementing tracking system where all documentation records of product inspection and acceptance are stored.
- Conducting manufacturing facility/site product inspection and acceptance for regulatory compliance.
Documenting experience: IN DESCRIBING YOUR EXPERIENCE PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of addition to describing duties performed applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.
Do not copy and paste the duties specialized experience or occupational application questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position.
In accordance with Office of Personnel Management policy federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employees position is creditable however when documented by satisfactory evidence such as a signed memorandum from the employees supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or if part time the percentage of times the other duties were performed. It is expected that this documentation is included in the employees official personnel order to receive credit for experience in your resume that is not within the official series and grade level of your official position you must provide a copy of the appropriate documentation of such experience as indicated above.
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; community; student; social). Volunteer work helps build critical competencies knowledge and skills and can provide valuable training and experience that translates directly to gain employment. You will receive credit for all qualifying experience including volunteer experience. If such experience is on a part-time basis you must provide the average number of hours worked per week as well as the beginning and ending dates of the experience so it can be fully credited.
OPM Qualification General Policies Website
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 further information visit: .
Note: Applications can be accepted from students who expect to complete qualifying education within 9 months from the date of application. Education was completed successfully before the applicant can be appointed.
THINGS YOU NEED TO KNOW
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.
Incentives may be authorized; however this is contingent upon multiple factors including funds availability. If authorized certain incentives may 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 may 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.
Bargaining Unit Position: No
Research position: No
Drug Screening Required: No
Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring.
Special Hiring Authorities for Veterans - Hiring Authorities for Military Spouses - With Disabilities (Schedule A) - Transition Assistance Program/Interagency Career Transition Assistance Program (CTAP/ICTAP): For information on how to apply as an CTAP/ICTAP eligible see To be well-qualified and exercise selection priority for this vacancy displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.
Reemployment Priority List (RPL): To receive selection priority for this position individuals on the RPL must meet the qualification requirements complete all required assessments and be rated as qualified. RPL candidates are ranked using Category Rating procedures.
Beginning January 1 2010 agencies must seek prior approval from OPM before they can appoint a current or recent political appointee to a competitive or non-political excepted service position at any level under the provisions of title 5 United States Code. If you are currently or have been within the last 5 years a political Schedule A Schedule C or Non-career SES employee in the executive branch you MUST disclose that to the Human Resources Office.
For Résumé Tips visit: Application Tips visit: additional information about USAJOBS visit the Help Center: 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
