Quality Assurance Specialist GS-1910-9 T-11
This position involves a multi-grade career ladder. The major duties listed below represent the full performance level of GS-11. At the GS-09 grade level, you will perform assignments of a more limited scope and with less independence. You will progressively acquire the background necessary to perform at the full performance level of GS-11. Promotion is at the discretion of the supervisor and is contingent upon satisfactory performance, availability of higher-level work, and availability of funds. Duties will include but may not be limited to the following:
Plans, develops, when approved implements and administers a wide variety of quality assurance management systems and procedures. Responsible for developing, testing/validating, implementing and managing changes to label designs. Maintain documentation for label generation, expedites, and other items related to the management of finished labels, label stock and materials. Provide Leadership in ensuring all label related inventory is available for new and ongoing projects. Coordinate and execute quality assurance of the design and text of labels in the clinical trials labels program. Interfaces with suppliers, and customers to select, analyze, and audit various processes and identify methodologies for process improvement to enhance customer satisfaction and ensure successful completion of clinical trials. Communicates with key officials, managers, contractors and other individuals within and outside the agency concerning quality requirements, investigations or clarifications to product and process specifications. Mentors and assists in the training of other Quality Assurance Specialists. Performs other duties as assigned. Work Schedule:
Monday - Friday 8:
00 am - 4:
30 pm Recruitment & Relocation Incentives:
Not authorized Financial Disclosure Report:
Not Required One (1) year of specialized experience and education directly related to the position. To be creditable, this experience and education must have been equivalent to at least the next lower grade level, GS-7 in the Federal Service that is directly related to the position. Specialized experience includes:
Providing pharmaceutical, regulatory, and study participant safety monitoring support for clinical research studies; providing quality control, central laboratory, and tissue banking services; managing quality assurance and quality control functions of assigned Studies. This experience must reflect in your resume. OR Possess at least 2 full years of progressively higher-level graduate education or master's or equivalent graduate degree or LL.B. or J.D., if related. This education must have been obtained in an accredited college or university. (COPY OF OFFICIAL OR UNOFFICIAL TRANSCRIPTS REQUIRED) OR An equivalent combination of successfully completed graduate education and experience may be used to meet total qualification requirements. This education must have been obtained in an accredited college or university. (COPY OF OFFICIAL OR UNOFFICIAL TRANSCRIPTS REQUIRED) You will be rated on the following Competencies as part of the assessment questionnaire for this position:
Attention to DetailComplianceCustomer ServiceQuality Assurance IMPORTANT:
A full year of work is considered to be 35-40 hours of work per week. All experience listed on your resume must include the month and year start/end dates. 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. 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; 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. 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.
Plans, develops, when approved implements and administers a wide variety of quality assurance management systems and procedures. Responsible for developing, testing/validating, implementing and managing changes to label designs. Maintain documentation for label generation, expedites, and other items related to the management of finished labels, label stock and materials. Provide Leadership in ensuring all label related inventory is available for new and ongoing projects. Coordinate and execute quality assurance of the design and text of labels in the clinical trials labels program. Interfaces with suppliers, and customers to select, analyze, and audit various processes and identify methodologies for process improvement to enhance customer satisfaction and ensure successful completion of clinical trials. Communicates with key officials, managers, contractors and other individuals within and outside the agency concerning quality requirements, investigations or clarifications to product and process specifications. Mentors and assists in the training of other Quality Assurance Specialists. Performs other duties as assigned. Work Schedule:
Monday - Friday 8:
00 am - 4:
30 pm Recruitment & Relocation Incentives:
Not authorized Financial Disclosure Report:
Not Required One (1) year of specialized experience and education directly related to the position. To be creditable, this experience and education must have been equivalent to at least the next lower grade level, GS-7 in the Federal Service that is directly related to the position. Specialized experience includes:
Providing pharmaceutical, regulatory, and study participant safety monitoring support for clinical research studies; providing quality control, central laboratory, and tissue banking services; managing quality assurance and quality control functions of assigned Studies. This experience must reflect in your resume. OR Possess at least 2 full years of progressively higher-level graduate education or master's or equivalent graduate degree or LL.B. or J.D., if related. This education must have been obtained in an accredited college or university. (COPY OF OFFICIAL OR UNOFFICIAL TRANSCRIPTS REQUIRED) OR An equivalent combination of successfully completed graduate education and experience may be used to meet total qualification requirements. This education must have been obtained in an accredited college or university. (COPY OF OFFICIAL OR UNOFFICIAL TRANSCRIPTS REQUIRED) You will be rated on the following Competencies as part of the assessment questionnaire for this position:
Attention to DetailComplianceCustomer ServiceQuality Assurance IMPORTANT:
A full year of work is considered to be 35-40 hours of work per week. All experience listed on your resume must include the month and year start/end dates. 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. 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; 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. 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:
$53,238 to $83,734 per year
Estimated Salary: $20 to $28 per hour based on qualifications.
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