Quality Assurance Specialist
The duties of the position include but are not limited to:
Establishing and maintaining a quality control program for all biospecimens received, stored, distributed to researchers. Aiding in the development of policies and procedures to ensure the proper collection, processing, storage, and distribution of biospecimens with appropriate references that are approved by designated personnel. Ensuring that an extensive audit trail is maintained for all specimens from receipt, processing, storage, distribution to destruction. Establishing and deploying roles, responsibilities, policies, and procedures concerning the acquisition, maintenance, dissemination, and disposition of biorepository data. Establishing processes that create or change data, determining authorities with respect to capturing and updating data, develops validation rules, handling rules, and quality constraints. Planning, developing, implementing and administering a wide variety of quality assurance management systems and procedures to support biotechnology projects and clinical trials. Developing, implementing, and assuring effective quality control procedures customized to every study, by identifying, proofing, measuring, and analyzing customer requirements. Serving as a technical expert in FDA regulatory requirements for biotechnology, drugs and medical devices. Communicating with key officials, managers, contractors and other individuals within and outside the agency concerning quality matters or investigations. Work Schedule:
Monday through Friday, 8:
00 am to 4:
30 pm Telework:
Not available Virtual:
This is not a virtual position. Position Description/PD#:
Quality Assurance Specialist/PDPD Relocation/Recruitment Incentives:
Not authorized Financial Disclosure Report:
Not required To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 02/28/2020. Time-In-Grade Requirement:
Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-12 position, you must have served 52 weeks at the GS-11. The grade may have been in any occupation, but must have been held in the Federal service. An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials. If the most recent SF-50 has an effective date within the past year, it may not clearly demonstrate you possess one-year time-in-grade, as required by the announcement. In this instance, you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade. Note:
Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment. You may qualify based on your experience as described below:
Specialized
Experience:
You must have one year of specialized experience (equivalent to at least the GS-11 level or pay band in the Federal service) that includes performing the following duties:
knowledge of quality control and assurance, including statistical analysis, sampling, and reporting techniques; knowledge and experience with Food and Drug Administration (FDA) current Good Manufacturing Practices and Drug Enforcement Agency (DEA) regulations as they apply to food, drug or cosmetics manufacturing, packaging, labeling, storage and distribution; planning, developing, and implementing quality systems; knowledge for evaluating product standards, characteristics, and technical specifications as they apply to quality levels achieved on products or packaging. You will be rated on the following Competencies for this position:
ComplianceData ManagementProject ManagementQuality Assurance 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; religions; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Note:
A full year of work is considered to be 35-40 hours of work per week. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. Physical Requirements:
The work requires climbing on ladders and stairs, the use of pallet jacks and other material handling equipment (MHE), the occasional lifting up to 40 lbs., and other activities related to a warehouse environment. Also requires the observing of manufacturing, packaging and labeling operations in the production of clinical supplies. For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https:
//www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/.
Estimated Salary: $20 to $28 per hour based on qualifications.
Establishing and maintaining a quality control program for all biospecimens received, stored, distributed to researchers. Aiding in the development of policies and procedures to ensure the proper collection, processing, storage, and distribution of biospecimens with appropriate references that are approved by designated personnel. Ensuring that an extensive audit trail is maintained for all specimens from receipt, processing, storage, distribution to destruction. Establishing and deploying roles, responsibilities, policies, and procedures concerning the acquisition, maintenance, dissemination, and disposition of biorepository data. Establishing processes that create or change data, determining authorities with respect to capturing and updating data, develops validation rules, handling rules, and quality constraints. Planning, developing, implementing and administering a wide variety of quality assurance management systems and procedures to support biotechnology projects and clinical trials. Developing, implementing, and assuring effective quality control procedures customized to every study, by identifying, proofing, measuring, and analyzing customer requirements. Serving as a technical expert in FDA regulatory requirements for biotechnology, drugs and medical devices. Communicating with key officials, managers, contractors and other individuals within and outside the agency concerning quality matters or investigations. Work Schedule:
Monday through Friday, 8:
00 am to 4:
30 pm Telework:
Not available Virtual:
This is not a virtual position. Position Description/PD#:
Quality Assurance Specialist/PDPD Relocation/Recruitment Incentives:
Not authorized Financial Disclosure Report:
Not required To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 02/28/2020. Time-In-Grade Requirement:
Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement. For a GS-12 position, you must have served 52 weeks at the GS-11. The grade may have been in any occupation, but must have been held in the Federal service. An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials. If the most recent SF-50 has an effective date within the past year, it may not clearly demonstrate you possess one-year time-in-grade, as required by the announcement. In this instance, you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade. Note:
Time-In-Grade requirements also apply to former Federal employees applying for reinstatement as well as current employees applying for Veterans Employment Opportunities Act of 1998 (VEOA) appointment. You may qualify based on your experience as described below:
Specialized
Experience:
You must have one year of specialized experience (equivalent to at least the GS-11 level or pay band in the Federal service) that includes performing the following duties:
knowledge of quality control and assurance, including statistical analysis, sampling, and reporting techniques; knowledge and experience with Food and Drug Administration (FDA) current Good Manufacturing Practices and Drug Enforcement Agency (DEA) regulations as they apply to food, drug or cosmetics manufacturing, packaging, labeling, storage and distribution; planning, developing, and implementing quality systems; knowledge for evaluating product standards, characteristics, and technical specifications as they apply to quality levels achieved on products or packaging. You will be rated on the following Competencies for this position:
ComplianceData ManagementProject ManagementQuality Assurance 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; religions; spiritual; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience. Note:
A full year of work is considered to be 35-40 hours of work per week. Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment. Physical Requirements:
The work requires climbing on ladders and stairs, the use of pallet jacks and other material handling equipment (MHE), the occasional lifting up to 40 lbs., and other activities related to a warehouse environment. Also requires the observing of manufacturing, packaging and labeling operations in the production of clinical supplies. For more information on these qualification standards, please visit the United States Office of Personnel Management's website at https:
//www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/.
- Department:
1910 Quality Assurance - Salary Range:
$77,204 to $100,369 per year
Estimated Salary: $20 to $28 per hour based on qualifications.
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