What are the responsibilities and job description for the Supervisory Quality Assurance Specialist position at U.S. Department of Veterans Affairs?
Summary
The VA Cooperative Studies Program (CSP) is part of the division of the Office of Research and Development - VA Central Office and is responsible for the planning and conducting of large multicenter controlled clinical trials (MCTs). CSP maintains a diverse portfolio of clinical research studies that seeks to provide definitive answers to important clinical questions on a national scale and on a range of diseases that affect Veterans and the nation.
Qualifications
To qualify for this position - applicants must meet all requirements by the closing date of this announcement - 05/26/2026. 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-13 position you must have served 52 weeks at the GS-12. 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. Note: This occupational series has an Individual Occupational Requirement (IOR). Individual Occupational Requirements (IORs) are requirements e.g. - experience or education - for particular occupational series or positions within a series and are used in conjunction with a group coverage (generic) standard. This position's IOR is:Education: To qualify for the Supervisory Quality Assurance Specialist position - you must possess an Undergraduate or Graduate degree in 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: 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. AND - For the GS-13 you must have the following: Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-12 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include - but are not limited to: Developing standard operation procedures (SOP) and policy creation related to quality control and assurance; Performing internal and external audits on processes and procedures to identify gaps in quality management and improvement opportunities; Overseeing contract development and performance monitoring for pharmaceutical products; and Managing a diverse staff and leading change within an organization through process quality improvement initiatives. 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/.
Duties
The VA Cooperative Studies Program (CSP) is part of the division of the Office of Research and Development - VA Central Office and is responsible for the planning and conducting of large multicenter controlled clinical trials (MCTs). CSP maintains a diverse portfolio of clinical research studies that seeks to provide definitive answers to important clinical questions on a national scale and on a range of diseases that affect Veterans and the nation.
Qualifications
To qualify for this position - applicants must meet all requirements by the closing date of this announcement - 05/26/2026. 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-13 position you must have served 52 weeks at the GS-12. 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. Note: This occupational series has an Individual Occupational Requirement (IOR). Individual Occupational Requirements (IORs) are requirements e.g. - experience or education - for particular occupational series or positions within a series and are used in conjunction with a group coverage (generic) standard. This position's IOR is:Education: To qualify for the Supervisory Quality Assurance Specialist position - you must possess an Undergraduate or Graduate degree in 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: 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. AND - For the GS-13 you must have the following: Specialized Experience: You must have one year of specialized experience equivalent to at least the next lower grade GS-12 in the normal line of progression for the occupation in the organization. Examples of specialized experience would typically include - but are not limited to: Developing standard operation procedures (SOP) and policy creation related to quality control and assurance; Performing internal and external audits on processes and procedures to identify gaps in quality management and improvement opportunities; Overseeing contract development and performance monitoring for pharmaceutical products; and Managing a diverse staff and leading change within an organization through process quality improvement initiatives. 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/.
Duties
- The duties of this position include - but are not limited to: Overseeing the daily operation of the Clinical Materials Manufacturing Section (CMMS) - Division of Technical Operations (DTO) ensuring that VA - CSP - PCC - FDA - DEA - and other regulatory partner regulations - policies and procedures are being followed - adequate resources and tools are available for CMMS staff Assists other Division of Technical Operations (DTO) and Division of Quality Assurance (DQA) Section Chiefs in the development of metrics necessary to determine the numbers and types of positions necessary to meet the current and future demands and complexities of DTO and MCTs Recommending and designing new quality programs to meet national needs with respect to the conduct of clinical trials manufacturing - packaging - labeling - and distribution Analyzing section financial situations and needs - determines and evaluates risk - and employs knowledge management tools and techniques to solve problems in executing studies - including identifying core competencies that create a quality culture and system Responsible for the staff training program in current cGMP - Corrective Action/Preventative Action (CAPA) - Root Cause Analysis (RCA) and is responsible for coordinating inhouse or contract training for PCC staff in cGMP Interpreting FDA regulations under 21 CFR 210 and 211 - Food and Drugs for applicability to specific drugs and medical devices and Federal guidelines governing the collection and use of biosamples associated with clinical trials supported by the PCC Plans - develops - and conducts methodologies to qualify suppliers of critical clinical trial materials (CTM) Conducting investigations and analyses of suspected adverse quality or conditions and when quality problems are detected - involving pharmaceuticals - devices - clinical supplies or biosamples - initiates and documents corrective action (CA) on the contractor producing those products or the collection - processing - storage and inventory of biospecimens Work Schedule: Monday - Friday - 7:30 - 4:00 Telework: This position may be authorized for telework
- Telework eligibility will be discussed during the interview process
- Virtual: This is not a virtual position
- Position Description/PD#: Supervisory Quality Assurance Specialist/PD931870 Relocation/Recruitment Incentives: Not Authorized Critical Skills Incentive (CSI): Not Approved Permanent Change of Station (PCS): Not Authorized
Salary : $107,592 - $139,871