Food and Drug Administration Consumer Safety Officer, GS-0696-12/13 in Silver Spring, Maryland
Food and Drug Administration
Many vacancies in the following location:
- Silver Spring, MD
Work Schedule is Full Time - Permanent
Opened Tuesday 7/26/2016 (90 day(s) ago)
** Closes Friday 12/30/2016 (67 day(s) away)
Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.
Who May Apply:Open to all United States Citizens
This is an Open Continuous Announcement with a closing date of December 30, 2016. The initial cut-off date for referral is August 6, 2016 or receipt of the 100th application (whichever comes first). After this date, additional referral lists will be created as vacancies are available.
This announcement covers multiple positions with the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation Research (CDER), including the following CDER offices:
The Office of Surveillance provide quality oversight for global manufacturing facilities and drug products using analytic tools and assessment approaches.
The Office of Process and Facilities assures that quality pharmaceuticals are consistently manufactured over the product life cycle through assessing design, technical adequacy and quality of manufacturing processes, controls and facilities described in drug application and manage the pre-approval inspections (PAI) program activities.
The Office of Manufacturing Quality plans, develops, and direct compliance and enforcement strategies and actions that are patient-focused and risk-based to secure the safety and quality of the nation's drug supply.
The Office of Unapproved Drugs and Labeling Compliance develops and implements policies, programs, and compliance strategies for protecting the public health by assuring compliance with the new drug and misbranding requirements of the Federal Food, Drug and Cosmetic Act.
The Office of Drug Security, Integrity and Response promotes and protects the integrity of the global supply chain throughout the drug lifecycle to minimize exposure to unsafe, ineffective and poor quality drugs.
The Office of Scientific Investigationsensures CDER-regulated products are safe and effective for the life of the product, through oversight and enforcement activities involving the reliability of safety and efficacy data submitted to FDA, the application of human subject protections in clinical trails, and the implementation of Risk Evaluation and Mitigation Strategies.
This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-16-MP-1752953JS *under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. *NOTE: Applicants must apply separately for each announcement in order to be considered.
Additional selections may be made within the same geographical area FDA-wide.
- Provides a focal point with the Food Drug Administration (FDA) to whom all levels of FDA personnel may turn for authoritative guidance and consultation regarding inspection and investigating methods and procedures necessary to accomplish compliance, enforcement, and regulatory objectives.
- Participates as a subject matter specialist in the onsite evaluation of field activities.
- Identifies areas which warrant study or improvement and prepares reports to ensure optimum efficiency and resource utilization.
- Reviews special and unusual problems submitted by various Center/Offices and provide authoritative guidance to the resolve the issues causing the problems.
- Conducts research into legal precedents and legislative history of the Acts enforced by FDA.
- Prepares position papers for top FDA managers based on such research.
- Drafts responses to correspondence from within and outside the agency concerning FDA regulated products.
- Provides support to agency task forces establishing new or receiving regulations procedures and programs having nation or international impact.
- Not Required
- U.S. Citizenship is required.
- Only experience gained by closing date.
- One year probationary period may be required.
Degree: that included at least 30 semester hours in one or combination of the following: biological science, chemistry, pharmacy, physical science, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours can include up to 8 hours in statistics or course work that included the principles, theory, or practical application f computers or computer programming,
Combination of education and experience-course consisting of at least 30 semester hours in the fields of study described in A above, plus appropriate experience or additional education.
In addition to the basic requirement:
GS-12:Have one year of specialized experience equivalent to the GS-11 grade level in the Federal service that include experience applying Current Good Manufacturing Practices (cGMPs) to drug manufacturing; drug quality assurance activities; designing, operations, testing or evaluating drug products, manufacturing processes, equipment, or facilities; experience in implementing or evaluating pharmaceutical quality system.
GS-13: Have one year of specialized experience equivalent to the GS-12 grade level in the Federal service that include complex decision making related to drug quality assurance, facility design, or processes controls related to drug manufacturing, validation or testing procedures; evaluating and making authoritative recommendations with respect to quality systems or compliance with Current Good Manufacturing Practices (cGMPs) regulations and other applicable requirements and policies; decision making and oversight of complex pharmaceutical issues such as quality assurance, manufacturing technology. infomatics, and automated related to drug production equipment, processes, facilities and computer systems.
If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. 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. For further information, click on foreign education.
Conditions of Employment: 1. Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. If hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action. 2. E-Verify: If you are selected for this position, the 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. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant. 3. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing. 4. Pre-employment physical required: No5. Drug testing required: No6. License required: No7. Mobility agreement required: No*8. Immunization required: No 9. 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. 10. Bargaining Unit Position: Yes *11. All qualification requirements must be met by the closing of the announcement. 12. Financial disclosure statement required: **No
Q - Nonsensitive
What To Expect Next
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We expect to make a selection within 45 days of the closing date of this announcement. Once this process is completed, you will be notified of your status via e-mail.
The Federal Government offers a comprehensive benefits package. Explore the major benefits offered to most Federal employees at http://www.usajobs.gov/ResourceCenter/Index/Interactive/Benefits#icc.
If you are a veteran with preference eligibility and you are claiming 5-points veterans' preference, you must submit a copy of your DD-214 (Member 4 copy) or other proof of eligibility. If you are claiming 10-point veterans' preference, you must also submit an SF-15, "Application for 10-Point Veterans' Preference" plus the proof required by that form. For more information on veterans preference see http://www.usajobs.gov/Veterans.
Males born after December 31, 1959 must be registered or exempt from Selective Service (see http://www.sss.gov).
For information on "People with Disabilities" please visit http://opm.gov/disability/PeopleWithDisabilities.asp
Career Transition Program: This program applies to Federal workers whose positions have been deemed surplus or no longer needed, or an employee who has been involuntarily separated from a Federal service position within the competitive service. To receive selection priority for this position, you must be rated well-qualified. Well-qualified means eligible applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements of the position. For information on how to apply and what documents to submit as an ICTAP eligible, see: http://www.opm.gov/rif/employeeguides/careertransition.asp
Salary Range: $77,490.00 to $119,794.00 / Per Year
Series & Grade: GS-0696-12/13
Promotion Potential: 13
Supervisory Status: No
Who May Apply: United States Citizens
Control Number: 444913600
Job Announcement Number: FDA-CDER-16-DE-1754016JS