8,626 Fda jobs in the United States
Quality Assurance Associate (FDA Regulatory)
23326 Chesapeake, Virginia
Family Dollar
Posted 15 days ago
Job Viewed
Job Description
**Family Dollar**
**Quality Assurance Associate**
_About Us_
Based in Chesapeake, VA, Family Dollar operates more than 7,000 stores across the 48 contiguous states, supported by a coast-to-coast logistics network and more than 80,000 Associates. Family Dollar is a leading value retailer serving large and small communities across the country. Come help us grow!
*Please note this role is not eligible for H1-B / Sponsorship*
_The Opportunity_
In this role, you will assist in completing the day-to-day responsibilities of the Quality Assurance Manager for product quality, safety, efficacy, development, and compliance to cGMP requirements. You will be trained and qualified to perform the job responsibilities for your assigned area(s), i.e., OTC drugs, medical devices, dietary supplements, and/or cosmetics, and may be cross-trained, as needed. Responsibilities include, but are not limited to, review of applicable documentation to approve or reject product lots, review of significant deviations, qualification and oversight of contracted facilities, the external audit program, quality agreements, review and maintenance of product and/or purchasing specifications, review and maintenance of product labels/labeling control, verification of appropriate warehousing and distribution practices, and other GMP quality functions such as preparing or revising standard operating procedures, training materials, and change controls, as needed.
_Specific responsibilities include but are not limited to:_
+ Review Certificates of Analysis, Certificates of Compliance, product specifications, and other documentation for completeness and correctness as per applicable procedures to approve or reject product lots. Complete and maintain appropriate documentation to support the disposition of product lots.
+ Complete a review of significant Deviation Investigations received from contract facilities, as defined in the Quality Agreement, to confirm that they meet the minimum requirements defined in Company SOPs.
+ Communicate with contract facility management as necessary to ensure the timely completion of required activities.
+ Review finished product and/or purchasing specifications against applicable standards to confirm conformance with regulatory requirements.
+ Assist in the vendor/supplier qualification program, including but not limited to performing audits or overseeing audits performed by third parties, developing an external audit schedule, assisting in the development of quality agreements, tracking the status of quality agreements, and maintaining an Approved Supplier List.
+ Assure that appropriate process validation and stability studies are conducted and retain samples are maintained to support Company private-label products.
+ Verify that transportation companies are following appropriate procedures, including but not limited to appropriate chain-of-custody and transportation conditions.
+ Verify that warehouse facilities are following appropriate procedures, including but not limited to appropriate storage conditions, pest control, handling of returns, and waste disposal.
+ Write, review, and revise standard operating procedures and forms, as necessary.
+ Write, review, and revise technical and quality system documents such as Change Controls and Deviation Reports, as needed.
+ Notify management of significant quality or compliance issues.
+ Assist the Quality Systems group with data collection for, and preparation of, metrics, Quality Council meeting materials, and Annual Product Reviews, as needed.
+ Assist in other functions, as needed.
**Minimum Requirements/Qualifications:**
+ Ability to work independently guided by documented procedures, with appropriate support.
+ Able to work effectively as part of a team.
+ Strong attention to detail.
+ Excellent verbal and written communication skills with the ability to interact across function, departments, seniority levels and contract facility management.
+ Ability to explain problems, develop solutions, and make recommendations, and the ability to handle various urgent requests in a professional manner.
+ Effective time management and interpersonal skills.
+ Ability to deliver within established timelines.
+ Proficient with Microsoft Office applications.
**Preferred Qualifications:**
+ Bachelor of Science degree in a science or engineering discipline.
+ Minimum 3 years of Quality work experience in FDA regulated industries. (pharmaceutical or medical device industry preferred).
+ Working knowledge of FDA Quality Systems (cGMP) and regulatory requirements (e.g., 21 CFR Parts 111, 210, 211, 700 and 820).
+ Thorough understanding of Good Documentation Practices
Full time
510 Volvo Parkway,Chesapeake,Virginia 23320
Compliance
Family Dollar
**Quality Assurance Associate**
_About Us_
Based in Chesapeake, VA, Family Dollar operates more than 7,000 stores across the 48 contiguous states, supported by a coast-to-coast logistics network and more than 80,000 Associates. Family Dollar is a leading value retailer serving large and small communities across the country. Come help us grow!
*Please note this role is not eligible for H1-B / Sponsorship*
_The Opportunity_
In this role, you will assist in completing the day-to-day responsibilities of the Quality Assurance Manager for product quality, safety, efficacy, development, and compliance to cGMP requirements. You will be trained and qualified to perform the job responsibilities for your assigned area(s), i.e., OTC drugs, medical devices, dietary supplements, and/or cosmetics, and may be cross-trained, as needed. Responsibilities include, but are not limited to, review of applicable documentation to approve or reject product lots, review of significant deviations, qualification and oversight of contracted facilities, the external audit program, quality agreements, review and maintenance of product and/or purchasing specifications, review and maintenance of product labels/labeling control, verification of appropriate warehousing and distribution practices, and other GMP quality functions such as preparing or revising standard operating procedures, training materials, and change controls, as needed.
_Specific responsibilities include but are not limited to:_
+ Review Certificates of Analysis, Certificates of Compliance, product specifications, and other documentation for completeness and correctness as per applicable procedures to approve or reject product lots. Complete and maintain appropriate documentation to support the disposition of product lots.
+ Complete a review of significant Deviation Investigations received from contract facilities, as defined in the Quality Agreement, to confirm that they meet the minimum requirements defined in Company SOPs.
+ Communicate with contract facility management as necessary to ensure the timely completion of required activities.
+ Review finished product and/or purchasing specifications against applicable standards to confirm conformance with regulatory requirements.
+ Assist in the vendor/supplier qualification program, including but not limited to performing audits or overseeing audits performed by third parties, developing an external audit schedule, assisting in the development of quality agreements, tracking the status of quality agreements, and maintaining an Approved Supplier List.
+ Assure that appropriate process validation and stability studies are conducted and retain samples are maintained to support Company private-label products.
+ Verify that transportation companies are following appropriate procedures, including but not limited to appropriate chain-of-custody and transportation conditions.
+ Verify that warehouse facilities are following appropriate procedures, including but not limited to appropriate storage conditions, pest control, handling of returns, and waste disposal.
+ Write, review, and revise standard operating procedures and forms, as necessary.
+ Write, review, and revise technical and quality system documents such as Change Controls and Deviation Reports, as needed.
+ Notify management of significant quality or compliance issues.
+ Assist the Quality Systems group with data collection for, and preparation of, metrics, Quality Council meeting materials, and Annual Product Reviews, as needed.
+ Assist in other functions, as needed.
**Minimum Requirements/Qualifications:**
+ Ability to work independently guided by documented procedures, with appropriate support.
+ Able to work effectively as part of a team.
+ Strong attention to detail.
+ Excellent verbal and written communication skills with the ability to interact across function, departments, seniority levels and contract facility management.
+ Ability to explain problems, develop solutions, and make recommendations, and the ability to handle various urgent requests in a professional manner.
+ Effective time management and interpersonal skills.
+ Ability to deliver within established timelines.
+ Proficient with Microsoft Office applications.
**Preferred Qualifications:**
+ Bachelor of Science degree in a science or engineering discipline.
+ Minimum 3 years of Quality work experience in FDA regulated industries. (pharmaceutical or medical device industry preferred).
+ Working knowledge of FDA Quality Systems (cGMP) and regulatory requirements (e.g., 21 CFR Parts 111, 210, 211, 700 and 820).
+ Thorough understanding of Good Documentation Practices
Full time
510 Volvo Parkway,Chesapeake,Virginia 23320
Compliance
Family Dollar
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0
Senior FDA Auditor
Caguas, Puerto Rico
LEGAL PROJECT MANAGEMENT PARTNERS LLC
Posted today
Job Viewed
Job Description
Job Description
Job Description
LOCATION: Caguas
Please submit a resume that includes a list of all relevant regulations you have audited under and the types of sites you have audited (e.g., manufacturers, CMOs, 3PLs, labs, sterilization processes, etc.).
We are looking for an FDA Auditor responsible with leading compliance audits within the pharmaceutical industry and its global supply chain. This role is critical in ensuring adherence to FDA regulations, cGMP standards, ICH guidelines, and international regulatory requirements . You will independently assess compliance, influence continuous improvement, and contribute to supplier quality strategies that safeguard patient safety and product integrity. This is a contract based opportunity for an independent professional willing to work on a hybrid environment (50% remote, 50% visiting client sites).
Main Responsibilities:
- Audit Leadership : Plan, conduct, and report external audits of pharmaceutical and medical device manufacturers, suppliers (API, raw materials, packaging, laboratories, 3PLs, CMOs), and distributors to assess compliance with FDA, cGMP, and global regulatory requirements (EMA, MHRA, WHO, Health Canada, ANVISA, INVIMA, PMDA, others).
- System & Process Evaluation : Evaluate quality systems, manufacturing operations, documentation, data integrity, and regulatory controls across diverse operations.
- Audit Reporting : Identify compliance gaps, issue comprehensive audit reports with risk ratings, and recommend actionable CAPAs.
- Collaboration & Mentorship : Partner with internal stakeholders on internal QA and supplier performance, provide regulatory guidance, and train/mentor junior auditors or cross-functional staff.
- Regulatory Preparedness : Support regulatory inspections, due diligence, and corporate supplier quality initiatives.
- Continuous Learning : Stay current with FDA guidance, ICH Q10/Q7, and evolving international regulations and industry best practices.
- Risk-Based Planning : Develop audit plans and schedules based on risk assessment, supplier criticality, and business needs.
- Follow-Up & Verification : May be required to monitor corrective and preventive actions, verify remediation effectiveness, and perform trend analysis to detect systemic issues.
General Requirements:
- Fluent in Spanish and English (spoken and written); additional languages a plus.
- Auditor certification is a plus
- Excellent verbal and written communication skills.
- Strong analytical, report-writing, and critical-thinking skills with attention to detail.
- Apply excellent problem-solving skills with a logical approach to resolutions.
- Excellent communication, influencing, and relationship-building skills—able to maintain independence while fostering constructive dialogue with suppliers.
- Ability to prioritize multiple audits and projects simultaneously, often under tight deadlines.
- Proficiency in Microsoft Office 365 (Teams, SharePoint, Excel, Word, PowerPoint, Outlook) and project management tools.
Education Requirements:
- Bachelor’s Degree in Life Sciences, Engineering or other related field.
- A combination of education and relevant experience may be considered.
Experience Requirements:
- Minimum 7+ years of FDA auditing or regulatory compliance experience within pharmaceuticals, biotech, or medical devices.
- Demonstrated expertise in FDA regulations, cGMP, GDP, ICH guidelines, and international quality systems.
- Experience auditing across manufacturing, packaging, labeling, laboratories, and distribution/3PLs.
- Familiarity with audit management systems (e.g., TrackWise, Veeva Vault, MasterControl) and quality data trending is a plus.
- ASQ Certified Quality Auditor (CQA)
- ISO 13485 or ISO 9001 Lead Auditor Certification
- Certified GMP Professional
- Training in GCP/GDP auditing is a plus
Physical Requirements:
- Ability to sit for long periods.
- Light physical activity may be required occasionally.
- Must be able to visit field locations as needed.
- Must be able to use personal protective equipment (PPE) when required.
- Ability to perform in a variety of industrial environments.
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1
Scrum Master Principal - FDA
20915 North Kensington, Maryland
General Dynamics Information Technology
Posted 2 days ago
Job Viewed
Job Description
**Req ID:** RQ
**Type of Requisition:** Regular
**Clearance Level Must Be Able to Obtain:** None
**Public Trust/Other Required:** MBI (T2)
**Job Family:** Software Engineering
**Skills:**
Agile Methodology,Atlassian JIRA,Scrum
**Experience:**
10 + years of related experience
**Job Description:**
General Dynamics Information Technology seeking a **Scrum Master Advisor** to support the **Food and Drug Administration (FDA)** and their critical mission needs.
As a Scrum Master Advisor, you will be an integral part of a scaling agile delivery team focused on delivering new customer-facing web-based applications with an emphasis on providing high value features to our customers and internal teams.
***This role is hybrid requiring 3 days onsite at GDIT's Gaithersburg, MD office and Silver Spring, MD client location.**
**Responsibilities:**
+ Organize and facilitate SCRUM ceremonies: daily standups, Sprint Planning/Grooming, Sprint Reviews/Demos, and Retrospectives
+ Maintain JIRA and other information radiators for the teams
+ Mentor and coach team members on core Agile values, principles, practices, and processes
+ Effectively highlight and share the team's successes through demos and reporting
+ Enable team to become self-organizing and self-managing to achieve its goals
+ Work with the functional team to develop release plans and ensure product backlogs are well-groomed, prioritized and visible to all stakeholders
+ Motivate teams to perform and ensure team members are collectively responsible for all aspects of the committed work (analysis, development, testing, documentation, etc.)
+ Identify, address, and communicate project risks, dependencies, and team impediments
+ Ensure the team's "definition of done" is well defined on the story, sprint, and release levels
+ Facilitate productivity through discussion, decision making, and conflict resolution
+ Shield the team from external interferences
+ Assist with internal and external communication, and improving transparency
+ Build a trusting and safe environment where problems can be raised with an emphasis on problem solving
+ Assess the Scrum maturity of the team and coach the team to higher levels of maturity at a pace that is sustainable and comfortable for the team
+ Coach a continuous improvement mindset and recommend adjustments to established delivery practices
+ Participate in Scrum of Scrum meetings to ensure cross-team collaboration and coordination of release plans and integration of testing activities
+ Establish and maintain strong working relationships with all stakeholders, including customers
**Required Skills and Experience:**
+ Bachelor's degree and 10+ of experience in Agile development environment (or Masters and 8+ years of experience).
+ Experience with using and implementing the Scaled Agile Framework (SAFe).
+ Experience with software development or working in software development organization.
+ Certified Scrum Master (CSM) or Agile Certified Scrum Master (PMI-ACP).
+ Experience using JIRA and Confluence.
+ Must be able to obtain and maintain a Public Trust with residency in the US 3 out of the last 5 years required.
**Preferred Skills and Experience:**
+ FDA experience strongly preferred.
+ Ability to manage multiple projects and work rapidly in a high tempo environment that often requires multitasking.
+ Ability to create, sustain, and enhance fostering of team dynamics and collaboration.
+ Energetic, goal oriented, proactive, innovative, hardworking, and patient.
#GDITFedHealthJobs
The likely salary range for this position is $102,000 - $138,000. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.
Join our Talent Community to stay up to date on our career opportunities and events at Opportunity Employer / Individuals with Disabilities / Protected Veterans
**Type of Requisition:** Regular
**Clearance Level Must Be Able to Obtain:** None
**Public Trust/Other Required:** MBI (T2)
**Job Family:** Software Engineering
**Skills:**
Agile Methodology,Atlassian JIRA,Scrum
**Experience:**
10 + years of related experience
**Job Description:**
General Dynamics Information Technology seeking a **Scrum Master Advisor** to support the **Food and Drug Administration (FDA)** and their critical mission needs.
As a Scrum Master Advisor, you will be an integral part of a scaling agile delivery team focused on delivering new customer-facing web-based applications with an emphasis on providing high value features to our customers and internal teams.
***This role is hybrid requiring 3 days onsite at GDIT's Gaithersburg, MD office and Silver Spring, MD client location.**
**Responsibilities:**
+ Organize and facilitate SCRUM ceremonies: daily standups, Sprint Planning/Grooming, Sprint Reviews/Demos, and Retrospectives
+ Maintain JIRA and other information radiators for the teams
+ Mentor and coach team members on core Agile values, principles, practices, and processes
+ Effectively highlight and share the team's successes through demos and reporting
+ Enable team to become self-organizing and self-managing to achieve its goals
+ Work with the functional team to develop release plans and ensure product backlogs are well-groomed, prioritized and visible to all stakeholders
+ Motivate teams to perform and ensure team members are collectively responsible for all aspects of the committed work (analysis, development, testing, documentation, etc.)
+ Identify, address, and communicate project risks, dependencies, and team impediments
+ Ensure the team's "definition of done" is well defined on the story, sprint, and release levels
+ Facilitate productivity through discussion, decision making, and conflict resolution
+ Shield the team from external interferences
+ Assist with internal and external communication, and improving transparency
+ Build a trusting and safe environment where problems can be raised with an emphasis on problem solving
+ Assess the Scrum maturity of the team and coach the team to higher levels of maturity at a pace that is sustainable and comfortable for the team
+ Coach a continuous improvement mindset and recommend adjustments to established delivery practices
+ Participate in Scrum of Scrum meetings to ensure cross-team collaboration and coordination of release plans and integration of testing activities
+ Establish and maintain strong working relationships with all stakeholders, including customers
**Required Skills and Experience:**
+ Bachelor's degree and 10+ of experience in Agile development environment (or Masters and 8+ years of experience).
+ Experience with using and implementing the Scaled Agile Framework (SAFe).
+ Experience with software development or working in software development organization.
+ Certified Scrum Master (CSM) or Agile Certified Scrum Master (PMI-ACP).
+ Experience using JIRA and Confluence.
+ Must be able to obtain and maintain a Public Trust with residency in the US 3 out of the last 5 years required.
**Preferred Skills and Experience:**
+ FDA experience strongly preferred.
+ Ability to manage multiple projects and work rapidly in a high tempo environment that often requires multitasking.
+ Ability to create, sustain, and enhance fostering of team dynamics and collaboration.
+ Energetic, goal oriented, proactive, innovative, hardworking, and patient.
#GDITFedHealthJobs
The likely salary range for this position is $102,000 - $138,000. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.
Join our Talent Community to stay up to date on our career opportunities and events at Opportunity Employer / Individuals with Disabilities / Protected Veterans
View Now
2
Scrum Master Principal - FDA
20898 Gaithersburg, Maryland
General Dynamics Information Technology
Posted 2 days ago
Job Viewed
Job Description
**Req ID:** RQ
**Type of Requisition:** Regular
**Clearance Level Must Be Able to Obtain:** None
**Public Trust/Other Required:** MBI (T2)
**Job Family:** Software Engineering
**Skills:**
Agile Methodology,Atlassian JIRA,Scrum
**Experience:**
10 + years of related experience
**Job Description:**
General Dynamics Information Technology seeking a **Scrum Master Advisor** to support the **Food and Drug Administration (FDA)** and their critical mission needs.
As a Scrum Master Advisor, you will be an integral part of a scaling agile delivery team focused on delivering new customer-facing web-based applications with an emphasis on providing high value features to our customers and internal teams.
***This role is hybrid requiring 3 days onsite at GDIT's Gaithersburg, MD office and Silver Spring, MD client location.**
**Responsibilities:**
+ Organize and facilitate SCRUM ceremonies: daily standups, Sprint Planning/Grooming, Sprint Reviews/Demos, and Retrospectives
+ Maintain JIRA and other information radiators for the teams
+ Mentor and coach team members on core Agile values, principles, practices, and processes
+ Effectively highlight and share the team's successes through demos and reporting
+ Enable team to become self-organizing and self-managing to achieve its goals
+ Work with the functional team to develop release plans and ensure product backlogs are well-groomed, prioritized and visible to all stakeholders
+ Motivate teams to perform and ensure team members are collectively responsible for all aspects of the committed work (analysis, development, testing, documentation, etc.)
+ Identify, address, and communicate project risks, dependencies, and team impediments
+ Ensure the team's "definition of done" is well defined on the story, sprint, and release levels
+ Facilitate productivity through discussion, decision making, and conflict resolution
+ Shield the team from external interferences
+ Assist with internal and external communication, and improving transparency
+ Build a trusting and safe environment where problems can be raised with an emphasis on problem solving
+ Assess the Scrum maturity of the team and coach the team to higher levels of maturity at a pace that is sustainable and comfortable for the team
+ Coach a continuous improvement mindset and recommend adjustments to established delivery practices
+ Participate in Scrum of Scrum meetings to ensure cross-team collaboration and coordination of release plans and integration of testing activities
+ Establish and maintain strong working relationships with all stakeholders, including customers
**Required Skills and Experience:**
+ Bachelor's degree and 10+ of experience in Agile development environment (or Masters and 8+ years of experience).
+ Experience with using and implementing the Scaled Agile Framework (SAFe).
+ Experience with software development or working in software development organization.
+ Certified Scrum Master (CSM) or Agile Certified Scrum Master (PMI-ACP).
+ Experience using JIRA and Confluence.
+ Must be able to obtain and maintain a Public Trust with residency in the US 3 out of the last 5 years required.
**Preferred Skills and Experience:**
+ FDA experience strongly preferred.
+ Ability to manage multiple projects and work rapidly in a high tempo environment that often requires multitasking.
+ Ability to create, sustain, and enhance fostering of team dynamics and collaboration.
+ Energetic, goal oriented, proactive, innovative, hardworking, and patient.
#GDITFedHealthJobs
The likely salary range for this position is $102,000 - $138,000. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.
Join our Talent Community to stay up to date on our career opportunities and events at Opportunity Employer / Individuals with Disabilities / Protected Veterans
**Type of Requisition:** Regular
**Clearance Level Must Be Able to Obtain:** None
**Public Trust/Other Required:** MBI (T2)
**Job Family:** Software Engineering
**Skills:**
Agile Methodology,Atlassian JIRA,Scrum
**Experience:**
10 + years of related experience
**Job Description:**
General Dynamics Information Technology seeking a **Scrum Master Advisor** to support the **Food and Drug Administration (FDA)** and their critical mission needs.
As a Scrum Master Advisor, you will be an integral part of a scaling agile delivery team focused on delivering new customer-facing web-based applications with an emphasis on providing high value features to our customers and internal teams.
***This role is hybrid requiring 3 days onsite at GDIT's Gaithersburg, MD office and Silver Spring, MD client location.**
**Responsibilities:**
+ Organize and facilitate SCRUM ceremonies: daily standups, Sprint Planning/Grooming, Sprint Reviews/Demos, and Retrospectives
+ Maintain JIRA and other information radiators for the teams
+ Mentor and coach team members on core Agile values, principles, practices, and processes
+ Effectively highlight and share the team's successes through demos and reporting
+ Enable team to become self-organizing and self-managing to achieve its goals
+ Work with the functional team to develop release plans and ensure product backlogs are well-groomed, prioritized and visible to all stakeholders
+ Motivate teams to perform and ensure team members are collectively responsible for all aspects of the committed work (analysis, development, testing, documentation, etc.)
+ Identify, address, and communicate project risks, dependencies, and team impediments
+ Ensure the team's "definition of done" is well defined on the story, sprint, and release levels
+ Facilitate productivity through discussion, decision making, and conflict resolution
+ Shield the team from external interferences
+ Assist with internal and external communication, and improving transparency
+ Build a trusting and safe environment where problems can be raised with an emphasis on problem solving
+ Assess the Scrum maturity of the team and coach the team to higher levels of maturity at a pace that is sustainable and comfortable for the team
+ Coach a continuous improvement mindset and recommend adjustments to established delivery practices
+ Participate in Scrum of Scrum meetings to ensure cross-team collaboration and coordination of release plans and integration of testing activities
+ Establish and maintain strong working relationships with all stakeholders, including customers
**Required Skills and Experience:**
+ Bachelor's degree and 10+ of experience in Agile development environment (or Masters and 8+ years of experience).
+ Experience with using and implementing the Scaled Agile Framework (SAFe).
+ Experience with software development or working in software development organization.
+ Certified Scrum Master (CSM) or Agile Certified Scrum Master (PMI-ACP).
+ Experience using JIRA and Confluence.
+ Must be able to obtain and maintain a Public Trust with residency in the US 3 out of the last 5 years required.
**Preferred Skills and Experience:**
+ FDA experience strongly preferred.
+ Ability to manage multiple projects and work rapidly in a high tempo environment that often requires multitasking.
+ Ability to create, sustain, and enhance fostering of team dynamics and collaboration.
+ Energetic, goal oriented, proactive, innovative, hardworking, and patient.
#GDITFedHealthJobs
The likely salary range for this position is $102,000 - $138,000. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.
Join our Talent Community to stay up to date on our career opportunities and events at Opportunity Employer / Individuals with Disabilities / Protected Veterans
View Now
3
Regulatory Affairs Specialist - FDA Compliance
20001 Washington, District Of Columbia
$110000 Annually
WhatJobs
Posted 2 days ago
Job Viewed
Job Description
Our client is seeking a detail-oriented and experienced Regulatory Affairs Specialist to ensure compliance with all applicable regulations, particularly those set by the U.S. Food and Drug Administration (FDA). This role is crucial for maintaining product safety, efficacy, and market access. The position requires a blend of remote work and in-office presence for key meetings and collaborations.
Key Responsibilities:
Key Responsibilities:
- Develop and implement regulatory strategies for product development and lifecycle management.
- Prepare and submit regulatory submissions (e.g., 510(k), PMA, IND, NDA) to the FDA and other relevant health authorities.
- Interpret and apply complex regulatory requirements to ensure product compliance.
- Review product labeling, marketing materials, and promotional claims for regulatory accuracy.
- Manage post-market surveillance activities, including adverse event reporting and complaint handling.
- Conduct regulatory audits and assessments to identify compliance gaps and recommend corrective actions.
- Stay current with changes in the regulatory landscape and provide updates to relevant teams.
- Collaborate with R&D, Quality Assurance, and Marketing departments to ensure regulatory requirements are met throughout the product lifecycle.
- Maintain regulatory documentation and databases.
- Bachelor's degree in Life Sciences, Chemistry, Pharmacy, or a related field; advanced degree preferred.
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical, medical device, or biotechnology industry.
- Thorough understanding of FDA regulations, guidances, and submission processes.
- Experience with specific regulatory pathways relevant to the company's product portfolio.
- Strong analytical, organizational, and project management skills.
- Excellent written and verbal communication skills, with the ability to communicate effectively with regulatory agencies and internal stakeholders.
- Proficiency in regulatory information management systems.
- Ability to work independently and as part of a team, with strong attention to detail.
Apply Now
4
Chemistry Operations Manager - FDA Detention
32601 Gainesville, Florida
Merieux NutriSciences Corporation
Posted 3 days ago
Job Viewed
Job Description
Chemistry Operations Manager - FDA Detention
Gainesville Analytical Laboratory
Regular
MERIEUX NUTRISCIENCES
As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food, environment and consumer goods. External growth has been a key pillar of our history with more than 40 acquisitions completed in the last 10 years.
If you want to contribute to an inspiring long-term purpose, to be part of a fast growing company on a high-value market with significant build-up opportunities, and to grow in an entrepreneurial and warm environment, join us!
YOUR DAY TO DAY LIFE
We are looking for a Chemistry Operations Manager - FDA Detention in 2183 SE Hawthorne Rd, Gainesville, FL 32641 USA. Your mission will be to:
Position Summary
The Operations Manager - FDA Detention Testing is responsible for leading a multidisciplinary chemistry team and ensuring operational excellence in all laboratory activities. This role is central to managing analytical chemistry services that support FDA detention testing, with a strong emphasis on compliance, accuracy, and timely execution. The Manager is accountable for overseeing laboratory operations, maintaining regulatory alignment, and driving continuous improvement initiatives that enhance both scientific and business performance.
This position requires deep expertise in analytical chemistry, strong leadership in managing high-performing teams, and proven success in balancing regulatory compliance, client expectations, and departmental financial health. The Laboratory Manager will serve as the key liaison to clients, FDA import officers, and internal stakeholders to ensure testing outcomes meet the highest standards of quality, integrity, and reliability.
Essential Functions and Responsibilities
* Provide overall leadership and operational management of analytical chemistry testing for FDA-detained imports.
* Ensure strict compliance with FDA regulatory requirements, GLP, ISO/IEC 17025, and other relevant industry standards.
* Oversee laboratory workflows including sample receipt, testing, data analysis, quality review, reporting, and client communication.
* Lead the development, validation, and implementation of robust analytical methods across diverse product categories (e.g., food, dietary supplements, spices).
* Supervise, mentor, and train laboratory staff to ensure technical excellence, regulatory awareness, and professional growth.
* Review, interpret, and approve analytical results, Certificates of Analysis (COAs), and QA/QC documentation to ensure accuracy and integrity.
* Serve as the primary liaison with FDA import officers, clients, and internal teams, ensuring transparency in testing scope, timelines, and deliverables.
* Prepare for and lead internal audits while ensuring readiness for external inspections by regulatory authorities.
* Drive continuous improvement initiatives, optimizing laboratory workflows, data integrity systems, and cost efficiency without compromising compliance.
* Oversee departmental P&L, ensuring financial accountability and sustainable business performance.
* Represent the company in client meetings, regulatory discussions, and industry forums with professionalism and scientific credibility.
* Ensure that all operations are conducted in alignment with ethical standards and the company's Code of Conduct.
* Other related duties as assigned.
* At any time, the incumbent must behave and operate in an ethical and Code of Conduct compliant manner.
YOUR PROFILE
Qualifications Required
* Bachelor's degree in Chemistry, Analytical Chemistry, or a related scientific discipline.
* Minimum of 5 years of experience in an analytical chemistry or regulatory testing laboratory.
* At least 3 years of proven supervisory or managerial experience in a laboratory environment.
* Demonstrated success in managing laboratory budgets, including cost control for reagents, instrumentation, and staffing.
* Strong knowledge of Good Laboratory Practices (GLP), ISO standards (ISO/IEC 17025 preferred), and regulatory testing environments.
Qualifications Desired
* Advanced degree (Master's or PhD) in Chemistry, Analytical Chemistry, Food Science, or a related field.
* Direct experience with FDA import detention testing protocols and regulatory compliance.
* Proficiency in advanced analytical instrumentation (HPLC, GC, LC-MS/MS, ICP-MS, wet chemistry methods).
* Demonstrated project management expertise and business acumen with a track record of delivering results on time and within scope.
* Strong leadership, strategic thinking, and problem-solving skills, with the ability to influence across departments.
* Excellent verbal and written communication skills, with experience representing laboratory services to clients and regulatory authorities.
Travel
* Occasional travel may be required to attend industry conferences or collaborate with other research facilities.
* Typically involves travel within the country and lasts for short durations (1-3 days).
Compensation Package Overview:
* Compensation Range $85,000-$95,000 annual salary USD
* Potential bonus: Up to 10% based on performance.
Full Time Eligible Benefits Overview:
* Comprehensive medical, dental, and vision insurance plans.
* Generous paid time off (PTO) package to support work-life balance following state and local ordinances.
* Optional 401(k) plan with employer matching contributions.
The information above provides a general overview and may vary based on specific job responsibilities, location, or other factors. Details will be clarified during the hiring process.
#LI-KC1
WHY JOIN US?
* Because you would contribute to an inspiring Public Health purpose, supported by long-term and visionary shareholders.
* Because you would have an impact on our strategic pillars that build on 50 years of experience and expertise.
* Because you would be part of a community of an enthusiastic and skilled group of people who love co-building together and serving a purpose bigger than them.
* Because you would be welcome as you are, in a diverse and open-minded environment that is rich in our singularities and differences.
* Because you would grow in an international group of more than 8200 fantastic team members, with plenty of opportunities to learn and share.
Ready for the journey?
To apply please click on 'Apply now' button
Gainesville Analytical Laboratory
Regular
MERIEUX NUTRISCIENCES
As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food, environment and consumer goods. External growth has been a key pillar of our history with more than 40 acquisitions completed in the last 10 years.
If you want to contribute to an inspiring long-term purpose, to be part of a fast growing company on a high-value market with significant build-up opportunities, and to grow in an entrepreneurial and warm environment, join us!
YOUR DAY TO DAY LIFE
We are looking for a Chemistry Operations Manager - FDA Detention in 2183 SE Hawthorne Rd, Gainesville, FL 32641 USA. Your mission will be to:
Position Summary
The Operations Manager - FDA Detention Testing is responsible for leading a multidisciplinary chemistry team and ensuring operational excellence in all laboratory activities. This role is central to managing analytical chemistry services that support FDA detention testing, with a strong emphasis on compliance, accuracy, and timely execution. The Manager is accountable for overseeing laboratory operations, maintaining regulatory alignment, and driving continuous improvement initiatives that enhance both scientific and business performance.
This position requires deep expertise in analytical chemistry, strong leadership in managing high-performing teams, and proven success in balancing regulatory compliance, client expectations, and departmental financial health. The Laboratory Manager will serve as the key liaison to clients, FDA import officers, and internal stakeholders to ensure testing outcomes meet the highest standards of quality, integrity, and reliability.
Essential Functions and Responsibilities
* Provide overall leadership and operational management of analytical chemistry testing for FDA-detained imports.
* Ensure strict compliance with FDA regulatory requirements, GLP, ISO/IEC 17025, and other relevant industry standards.
* Oversee laboratory workflows including sample receipt, testing, data analysis, quality review, reporting, and client communication.
* Lead the development, validation, and implementation of robust analytical methods across diverse product categories (e.g., food, dietary supplements, spices).
* Supervise, mentor, and train laboratory staff to ensure technical excellence, regulatory awareness, and professional growth.
* Review, interpret, and approve analytical results, Certificates of Analysis (COAs), and QA/QC documentation to ensure accuracy and integrity.
* Serve as the primary liaison with FDA import officers, clients, and internal teams, ensuring transparency in testing scope, timelines, and deliverables.
* Prepare for and lead internal audits while ensuring readiness for external inspections by regulatory authorities.
* Drive continuous improvement initiatives, optimizing laboratory workflows, data integrity systems, and cost efficiency without compromising compliance.
* Oversee departmental P&L, ensuring financial accountability and sustainable business performance.
* Represent the company in client meetings, regulatory discussions, and industry forums with professionalism and scientific credibility.
* Ensure that all operations are conducted in alignment with ethical standards and the company's Code of Conduct.
* Other related duties as assigned.
* At any time, the incumbent must behave and operate in an ethical and Code of Conduct compliant manner.
YOUR PROFILE
Qualifications Required
* Bachelor's degree in Chemistry, Analytical Chemistry, or a related scientific discipline.
* Minimum of 5 years of experience in an analytical chemistry or regulatory testing laboratory.
* At least 3 years of proven supervisory or managerial experience in a laboratory environment.
* Demonstrated success in managing laboratory budgets, including cost control for reagents, instrumentation, and staffing.
* Strong knowledge of Good Laboratory Practices (GLP), ISO standards (ISO/IEC 17025 preferred), and regulatory testing environments.
Qualifications Desired
* Advanced degree (Master's or PhD) in Chemistry, Analytical Chemistry, Food Science, or a related field.
* Direct experience with FDA import detention testing protocols and regulatory compliance.
* Proficiency in advanced analytical instrumentation (HPLC, GC, LC-MS/MS, ICP-MS, wet chemistry methods).
* Demonstrated project management expertise and business acumen with a track record of delivering results on time and within scope.
* Strong leadership, strategic thinking, and problem-solving skills, with the ability to influence across departments.
* Excellent verbal and written communication skills, with experience representing laboratory services to clients and regulatory authorities.
Travel
* Occasional travel may be required to attend industry conferences or collaborate with other research facilities.
* Typically involves travel within the country and lasts for short durations (1-3 days).
Compensation Package Overview:
* Compensation Range $85,000-$95,000 annual salary USD
* Potential bonus: Up to 10% based on performance.
Full Time Eligible Benefits Overview:
* Comprehensive medical, dental, and vision insurance plans.
* Generous paid time off (PTO) package to support work-life balance following state and local ordinances.
* Optional 401(k) plan with employer matching contributions.
The information above provides a general overview and may vary based on specific job responsibilities, location, or other factors. Details will be clarified during the hiring process.
#LI-KC1
WHY JOIN US?
* Because you would contribute to an inspiring Public Health purpose, supported by long-term and visionary shareholders.
* Because you would have an impact on our strategic pillars that build on 50 years of experience and expertise.
* Because you would be part of a community of an enthusiastic and skilled group of people who love co-building together and serving a purpose bigger than them.
* Because you would be welcome as you are, in a diverse and open-minded environment that is rich in our singularities and differences.
* Because you would grow in an international group of more than 8200 fantastic team members, with plenty of opportunities to learn and share.
Ready for the journey?
To apply please click on 'Apply now' button
View Now
5
Chemistry Operations Manager - FDA Detention
32635 Gainesville, Florida
Merieux NutriSciences
Posted today
Job Viewed
Job Description
Chemistry Operations Manager - FDA Detention
Gainesville Analytical Laboratory
Regular
MERIEUX NUTRISCIENCES
As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food, environment and consumer goods. External growth has been a key pillar of our history with more than 40 acquisitions completed in the last 10 years.
If you want to contribute to an inspiring long-term purpose, to be part of a fast growing company on a high-value market with significant build-up opportunities, and to grow in an entrepreneurial and warm environment, join us!
YOUR DAY TO DAY LIFE
We are looking for a Chemistry Operations Manager - FDA Detention in 2183 SE Hawthorne Rd, Gainesville, FL 32641 USA. Your mission will be to:
Position Summary
The Operations Manager - FDA Detention Testing is responsible for leading a multidisciplinary chemistry team and ensuring operational excellence in all laboratory activities. This role is central to managing analytical chemistry services that support FDA detention testing, with a strong emphasis on compliance, accuracy, and timely execution. The Manager is accountable for overseeing laboratory operations, maintaining regulatory alignment, and driving continuous improvement initiatives that enhance both scientific and business performance.
This position requires deep expertise in analytical chemistry, strong leadership in managing high-performing teams, and proven success in balancing regulatory compliance, client expectations, and departmental financial health. The Laboratory Manager will serve as the key liaison to clients, FDA import officers, and internal stakeholders to ensure testing outcomes meet the highest standards of quality, integrity, and reliability.
Essential Functions and Responsibilities
Qualifications Required
#LI-KC1
WHY JOIN US?
Ready for the journey?
To apply please click on 'Apply now' button
recblid q4oaih3fowym15k4a9czbu6vjiyl9e
Gainesville Analytical Laboratory
Regular
MERIEUX NUTRISCIENCES
As a trusted partner, our Public Health mission is to make food systems safer, healthier and more sustainable. Throughout our global network in 27 countries, we offer to our customers a wide range of testing and innovative solutions dedicated to preventing health risks related to food, environment and consumer goods. External growth has been a key pillar of our history with more than 40 acquisitions completed in the last 10 years.
If you want to contribute to an inspiring long-term purpose, to be part of a fast growing company on a high-value market with significant build-up opportunities, and to grow in an entrepreneurial and warm environment, join us!
YOUR DAY TO DAY LIFE
We are looking for a Chemistry Operations Manager - FDA Detention in 2183 SE Hawthorne Rd, Gainesville, FL 32641 USA. Your mission will be to:
Position Summary
The Operations Manager - FDA Detention Testing is responsible for leading a multidisciplinary chemistry team and ensuring operational excellence in all laboratory activities. This role is central to managing analytical chemistry services that support FDA detention testing, with a strong emphasis on compliance, accuracy, and timely execution. The Manager is accountable for overseeing laboratory operations, maintaining regulatory alignment, and driving continuous improvement initiatives that enhance both scientific and business performance.
This position requires deep expertise in analytical chemistry, strong leadership in managing high-performing teams, and proven success in balancing regulatory compliance, client expectations, and departmental financial health. The Laboratory Manager will serve as the key liaison to clients, FDA import officers, and internal stakeholders to ensure testing outcomes meet the highest standards of quality, integrity, and reliability.
Essential Functions and Responsibilities
- Provide overall leadership and operational management of analytical chemistry testing for FDA-detained imports.
- Ensure strict compliance with FDA regulatory requirements, GLP, ISO/IEC 17025, and other relevant industry standards.
- Oversee laboratory workflows including sample receipt, testing, data analysis, quality review, reporting, and client communication.
- Lead the development, validation, and implementation of robust analytical methods across diverse product categories (e.g., food, dietary supplements, spices).
- Supervise, mentor, and train laboratory staff to ensure technical excellence, regulatory awareness, and professional growth.
- Review, interpret, and approve analytical results, Certificates of Analysis (COAs), and QA/QC documentation to ensure accuracy and integrity.
- Serve as the primary liaison with FDA import officers, clients, and internal teams, ensuring transparency in testing scope, timelines, and deliverables.
- Prepare for and lead internal audits while ensuring readiness for external inspections by regulatory authorities.
- Drive continuous improvement initiatives, optimizing laboratory workflows, data integrity systems, and cost efficiency without compromising compliance.
- Oversee departmental P&L, ensuring financial accountability and sustainable business performance.
- Represent the company in client meetings, regulatory discussions, and industry forums with professionalism and scientific credibility.
- Ensure that all operations are conducted in alignment with ethical standards and the company's Code of Conduct.
- Other related duties as assigned.
- At any time, the incumbent must behave and operate in an ethical and Code of Conduct compliant manner.
Qualifications Required
- Bachelor's degree in Chemistry, Analytical Chemistry, or a related scientific discipline.
- Minimum of 5 years of experience in an analytical chemistry or regulatory testing laboratory.
- At least 3 years of proven supervisory or managerial experience in a laboratory environment.
- Demonstrated success in managing laboratory budgets, including cost control for reagents, instrumentation, and staffing.
- Strong knowledge of Good Laboratory Practices (GLP), ISO standards (ISO/IEC 17025 preferred), and regulatory testing environments.
- Advanced degree (Master's or PhD) in Chemistry, Analytical Chemistry, Food Science, or a related field.
- Direct experience with FDA import detention testing protocols and regulatory compliance.
- Proficiency in advanced analytical instrumentation (HPLC, GC, LC-MS/MS, ICP-MS, wet chemistry methods).
- Demonstrated project management expertise and business acumen with a track record of delivering results on time and within scope.
- Strong leadership, strategic thinking, and problem-solving skills, with the ability to influence across departments.
- Excellent verbal and written communication skills, with experience representing laboratory services to clients and regulatory authorities.
- Occasional travel may be required to attend industry conferences or collaborate with other research facilities.
- Typically involves travel within the country and lasts for short durations (1-3 days).
- Compensation Range $85,000-$95,000 annual salary USD
- Potential bonus: Up to 10% based on performance.
- Comprehensive medical, dental, and vision insurance plans.
- Generous paid time off (PTO) package to support work-life balance following state and local ordinances.
- Optional 401(k) plan with employer matching contributions.
#LI-KC1
WHY JOIN US?
- Because you would contribute to an inspiring Public Health purpose, supported by long-term and visionary shareholders.
- Because you would have an impact on our strategic pillars that build on 50 years of experience and expertise.
- Because you would be part of a community of an enthusiastic and skilled group of people who love co-building together and serving a purpose bigger than them.
- Because you would be welcome as you are , in a diverse and open-minded environment that is rich in our singularities and differences.
- Because you would grow in an international group of more than 8200 fantastic team members , with plenty of opportunities to learn and share.
Ready for the journey?
To apply please click on 'Apply now' button
recblid q4oaih3fowym15k4a9czbu6vjiyl9e
View Now
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About the latest Fda Jobs in United States !
6
Sr. Business Requirements Analyst - FDA
20915 North Kensington, Maryland
General Dynamics Information Technology
Posted 2 days ago
Job Viewed
Job Description
**Req ID:** RQ
**Type of Requisition:** Regular
**Clearance Level Must Be Able to Obtain:** None
**Public Trust/Other Required:** MBI (T2)
**Job Family:** Process and Operational Efficiency
**Skills:**
Business Analysis,Business Requirements,Information Systems,Requirement Documents
**Experience:**
10 + years of related experience
**Job Description:**
General Dynamics Information Technology is a **S** **enior-level Business Requirements Analyst** for new contract to support the **Food and Drug Administration (FDA)** and their critical mission needs.
As a Business Requirements Analyst, you will be part of an agile delivery team focused on delivering new customer-facing web-based applications with an emphasis on providing high value features to our customers. You will serve as a core support member for the team working closely with the Product Owner and high performing development team to help manage the product. The primary responsibility will be to integrate the needs of the projects as well as the needs of several different stakeholders to produce an overall solution.
The ideal candidate is someone with strong requirements analysis skills and UI/UX knowledge combined with the ability to clearly communicate technical concepts. A successful candidate will have the appropriate experience and business understanding to prioritize initiatives and work with both management and our clients.
*** Current or past experience working at the FDA in a similar capacity is required.**
**This is a hybrid position with a 3 day on-site requirement at the GDIT office in Gaithersburg, MD and/or the FDA office in Silver Spring, MD.**
**Responsibilities:**
+ Assists in analyzing and documenting client's business requirements and processes; communicates these requirements to technical personnel by constructing basic conceptual data and process models, including data dictionaries and volume estimates.
+ Assists in planning and designing business processes; assists in formulating recommendations to improve and support business activities.
+ Assists in creating basic test scenarios to be used in testing the business applications to verify that client requirements are incorporated into the system design.
+ Assists in developing and modifying systems requirements documentation to meet client needs and explore potential solutions.
+ Provide detailed user stories and requirements to technical leads in support of sprint planning activities.
+ Executes systems test from existing test plans. Assists in analyzing testing results in all phases.
+ Participates in technical reviews and inspections to verify 'intent of change' is carried through phases of project.
+ Support Product Owners in their management of requirements and product features.
+ Assist with the management of requirements and collaboration sessions using tools like JIRA and Confluence.
+ Assist in the research and assessment of business goals, objectives and needs to align information technology solutions with business initiatives.
+ Conduct testing such as functional testing and user acceptance testing (UAT).
+ Assists Product Owner to define and prioritize the team backlog of work so that solution effectively addresses business and program priorities.
**Required Qualifications and Skills:**
+ Bachelors degree and 10+ years of business analyst experience within the Information Technology industry required
+ 6+ years working within the Federal Government or working with Federal Government agencies
+ **Current or past experience working at the FDA in a similar capacity required**
+ Involvement leading sprint planning meetings and client meetings and preparing slide decks and other materials to supplement these meetings
+ Expertise in requirements gathering process from start to finish
+ Experience writing user stories
+ Knowledge of software development life-cycle methodologies
+ Experience working with Agile/SCRUM, writing user stories and following the development process through user story acceptance
+ Experience with Atlassian tools (JIRA, Confluence)
**Desired Qualifications and Skills:**
+ FDA CDER experience strongly preferred
+ Proficiency in UI/UX, building process flows, wireframes, and mockups
+ Professional Agile certification
+ Experience with Appian or similar COTS products.
+ Experience with User Experience and User Interface Design Process and Documentation
+ COTS/Low code (Appian, Pega, SalesForce, etc.) experience
+ Excellent written communication and presentation skills
+ Self-motivated, highly organized individual
#GDITFedHealthJobs
#GDITFedHealthJobs-FDA
The likely salary range for this position is $123,250 - $166,750. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.
Join our Talent Community to stay up to date on our career opportunities and events at Opportunity Employer / Individuals with Disabilities / Protected Veterans
**Type of Requisition:** Regular
**Clearance Level Must Be Able to Obtain:** None
**Public Trust/Other Required:** MBI (T2)
**Job Family:** Process and Operational Efficiency
**Skills:**
Business Analysis,Business Requirements,Information Systems,Requirement Documents
**Experience:**
10 + years of related experience
**Job Description:**
General Dynamics Information Technology is a **S** **enior-level Business Requirements Analyst** for new contract to support the **Food and Drug Administration (FDA)** and their critical mission needs.
As a Business Requirements Analyst, you will be part of an agile delivery team focused on delivering new customer-facing web-based applications with an emphasis on providing high value features to our customers. You will serve as a core support member for the team working closely with the Product Owner and high performing development team to help manage the product. The primary responsibility will be to integrate the needs of the projects as well as the needs of several different stakeholders to produce an overall solution.
The ideal candidate is someone with strong requirements analysis skills and UI/UX knowledge combined with the ability to clearly communicate technical concepts. A successful candidate will have the appropriate experience and business understanding to prioritize initiatives and work with both management and our clients.
*** Current or past experience working at the FDA in a similar capacity is required.**
**This is a hybrid position with a 3 day on-site requirement at the GDIT office in Gaithersburg, MD and/or the FDA office in Silver Spring, MD.**
**Responsibilities:**
+ Assists in analyzing and documenting client's business requirements and processes; communicates these requirements to technical personnel by constructing basic conceptual data and process models, including data dictionaries and volume estimates.
+ Assists in planning and designing business processes; assists in formulating recommendations to improve and support business activities.
+ Assists in creating basic test scenarios to be used in testing the business applications to verify that client requirements are incorporated into the system design.
+ Assists in developing and modifying systems requirements documentation to meet client needs and explore potential solutions.
+ Provide detailed user stories and requirements to technical leads in support of sprint planning activities.
+ Executes systems test from existing test plans. Assists in analyzing testing results in all phases.
+ Participates in technical reviews and inspections to verify 'intent of change' is carried through phases of project.
+ Support Product Owners in their management of requirements and product features.
+ Assist with the management of requirements and collaboration sessions using tools like JIRA and Confluence.
+ Assist in the research and assessment of business goals, objectives and needs to align information technology solutions with business initiatives.
+ Conduct testing such as functional testing and user acceptance testing (UAT).
+ Assists Product Owner to define and prioritize the team backlog of work so that solution effectively addresses business and program priorities.
**Required Qualifications and Skills:**
+ Bachelors degree and 10+ years of business analyst experience within the Information Technology industry required
+ 6+ years working within the Federal Government or working with Federal Government agencies
+ **Current or past experience working at the FDA in a similar capacity required**
+ Involvement leading sprint planning meetings and client meetings and preparing slide decks and other materials to supplement these meetings
+ Expertise in requirements gathering process from start to finish
+ Experience writing user stories
+ Knowledge of software development life-cycle methodologies
+ Experience working with Agile/SCRUM, writing user stories and following the development process through user story acceptance
+ Experience with Atlassian tools (JIRA, Confluence)
**Desired Qualifications and Skills:**
+ FDA CDER experience strongly preferred
+ Proficiency in UI/UX, building process flows, wireframes, and mockups
+ Professional Agile certification
+ Experience with Appian or similar COTS products.
+ Experience with User Experience and User Interface Design Process and Documentation
+ COTS/Low code (Appian, Pega, SalesForce, etc.) experience
+ Excellent written communication and presentation skills
+ Self-motivated, highly organized individual
#GDITFedHealthJobs
#GDITFedHealthJobs-FDA
The likely salary range for this position is $123,250 - $166,750. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.
Join our Talent Community to stay up to date on our career opportunities and events at Opportunity Employer / Individuals with Disabilities / Protected Veterans
View Now
7
Sr. Business Requirements Analyst - FDA
20898 Gaithersburg, Maryland
General Dynamics Information Technology
Posted 2 days ago
Job Viewed
Job Description
**Req ID:** RQ
**Type of Requisition:** Regular
**Clearance Level Must Be Able to Obtain:** None
**Public Trust/Other Required:** MBI (T2)
**Job Family:** Process and Operational Efficiency
**Skills:**
Business Analysis,Business Requirements,Information Systems,Requirement Documents
**Experience:**
10 + years of related experience
**Job Description:**
General Dynamics Information Technology is a **S** **enior-level Business Requirements Analyst** for new contract to support the **Food and Drug Administration (FDA)** and their critical mission needs.
As a Business Requirements Analyst, you will be part of an agile delivery team focused on delivering new customer-facing web-based applications with an emphasis on providing high value features to our customers. You will serve as a core support member for the team working closely with the Product Owner and high performing development team to help manage the product. The primary responsibility will be to integrate the needs of the projects as well as the needs of several different stakeholders to produce an overall solution.
The ideal candidate is someone with strong requirements analysis skills and UI/UX knowledge combined with the ability to clearly communicate technical concepts. A successful candidate will have the appropriate experience and business understanding to prioritize initiatives and work with both management and our clients.
*** Current or past experience working at the FDA in a similar capacity is required.**
**This is a hybrid position with a 3 day on-site requirement at the GDIT office in Gaithersburg, MD and/or the FDA office in Silver Spring, MD.**
**Responsibilities:**
+ Assists in analyzing and documenting client's business requirements and processes; communicates these requirements to technical personnel by constructing basic conceptual data and process models, including data dictionaries and volume estimates.
+ Assists in planning and designing business processes; assists in formulating recommendations to improve and support business activities.
+ Assists in creating basic test scenarios to be used in testing the business applications to verify that client requirements are incorporated into the system design.
+ Assists in developing and modifying systems requirements documentation to meet client needs and explore potential solutions.
+ Provide detailed user stories and requirements to technical leads in support of sprint planning activities.
+ Executes systems test from existing test plans. Assists in analyzing testing results in all phases.
+ Participates in technical reviews and inspections to verify 'intent of change' is carried through phases of project.
+ Support Product Owners in their management of requirements and product features.
+ Assist with the management of requirements and collaboration sessions using tools like JIRA and Confluence.
+ Assist in the research and assessment of business goals, objectives and needs to align information technology solutions with business initiatives.
+ Conduct testing such as functional testing and user acceptance testing (UAT).
+ Assists Product Owner to define and prioritize the team backlog of work so that solution effectively addresses business and program priorities.
**Required Qualifications and Skills:**
+ Bachelors degree and 10+ years of business analyst experience within the Information Technology industry required
+ 6+ years working within the Federal Government or working with Federal Government agencies
+ **Current or past experience working at the FDA in a similar capacity required**
+ Involvement leading sprint planning meetings and client meetings and preparing slide decks and other materials to supplement these meetings
+ Expertise in requirements gathering process from start to finish
+ Experience writing user stories
+ Knowledge of software development life-cycle methodologies
+ Experience working with Agile/SCRUM, writing user stories and following the development process through user story acceptance
+ Experience with Atlassian tools (JIRA, Confluence)
**Desired Qualifications and Skills:**
+ FDA CDER experience strongly preferred
+ Proficiency in UI/UX, building process flows, wireframes, and mockups
+ Professional Agile certification
+ Experience with Appian or similar COTS products.
+ Experience with User Experience and User Interface Design Process and Documentation
+ COTS/Low code (Appian, Pega, SalesForce, etc.) experience
+ Excellent written communication and presentation skills
+ Self-motivated, highly organized individual
#GDITFedHealthJobs
#GDITFedHealthJobs-FDA
The likely salary range for this position is $123,250 - $166,750. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.
Join our Talent Community to stay up to date on our career opportunities and events at Opportunity Employer / Individuals with Disabilities / Protected Veterans
**Type of Requisition:** Regular
**Clearance Level Must Be Able to Obtain:** None
**Public Trust/Other Required:** MBI (T2)
**Job Family:** Process and Operational Efficiency
**Skills:**
Business Analysis,Business Requirements,Information Systems,Requirement Documents
**Experience:**
10 + years of related experience
**Job Description:**
General Dynamics Information Technology is a **S** **enior-level Business Requirements Analyst** for new contract to support the **Food and Drug Administration (FDA)** and their critical mission needs.
As a Business Requirements Analyst, you will be part of an agile delivery team focused on delivering new customer-facing web-based applications with an emphasis on providing high value features to our customers. You will serve as a core support member for the team working closely with the Product Owner and high performing development team to help manage the product. The primary responsibility will be to integrate the needs of the projects as well as the needs of several different stakeholders to produce an overall solution.
The ideal candidate is someone with strong requirements analysis skills and UI/UX knowledge combined with the ability to clearly communicate technical concepts. A successful candidate will have the appropriate experience and business understanding to prioritize initiatives and work with both management and our clients.
*** Current or past experience working at the FDA in a similar capacity is required.**
**This is a hybrid position with a 3 day on-site requirement at the GDIT office in Gaithersburg, MD and/or the FDA office in Silver Spring, MD.**
**Responsibilities:**
+ Assists in analyzing and documenting client's business requirements and processes; communicates these requirements to technical personnel by constructing basic conceptual data and process models, including data dictionaries and volume estimates.
+ Assists in planning and designing business processes; assists in formulating recommendations to improve and support business activities.
+ Assists in creating basic test scenarios to be used in testing the business applications to verify that client requirements are incorporated into the system design.
+ Assists in developing and modifying systems requirements documentation to meet client needs and explore potential solutions.
+ Provide detailed user stories and requirements to technical leads in support of sprint planning activities.
+ Executes systems test from existing test plans. Assists in analyzing testing results in all phases.
+ Participates in technical reviews and inspections to verify 'intent of change' is carried through phases of project.
+ Support Product Owners in their management of requirements and product features.
+ Assist with the management of requirements and collaboration sessions using tools like JIRA and Confluence.
+ Assist in the research and assessment of business goals, objectives and needs to align information technology solutions with business initiatives.
+ Conduct testing such as functional testing and user acceptance testing (UAT).
+ Assists Product Owner to define and prioritize the team backlog of work so that solution effectively addresses business and program priorities.
**Required Qualifications and Skills:**
+ Bachelors degree and 10+ years of business analyst experience within the Information Technology industry required
+ 6+ years working within the Federal Government or working with Federal Government agencies
+ **Current or past experience working at the FDA in a similar capacity required**
+ Involvement leading sprint planning meetings and client meetings and preparing slide decks and other materials to supplement these meetings
+ Expertise in requirements gathering process from start to finish
+ Experience writing user stories
+ Knowledge of software development life-cycle methodologies
+ Experience working with Agile/SCRUM, writing user stories and following the development process through user story acceptance
+ Experience with Atlassian tools (JIRA, Confluence)
**Desired Qualifications and Skills:**
+ FDA CDER experience strongly preferred
+ Proficiency in UI/UX, building process flows, wireframes, and mockups
+ Professional Agile certification
+ Experience with Appian or similar COTS products.
+ Experience with User Experience and User Interface Design Process and Documentation
+ COTS/Low code (Appian, Pega, SalesForce, etc.) experience
+ Excellent written communication and presentation skills
+ Self-motivated, highly organized individual
#GDITFedHealthJobs
#GDITFedHealthJobs-FDA
The likely salary range for this position is $123,250 - $166,750. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.
We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.
Join our Talent Community to stay up to date on our career opportunities and events at Opportunity Employer / Individuals with Disabilities / Protected Veterans
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8
Underage Purchaser - FDA Tobacco Inspection Program
Charlotte, North Carolina
Bizzell Group
Posted today
Job Viewed
Job Description
Job Description
Job Description
Description:
Location: Statewide, North Carolina
Job Type: Part-Time, Temporary
Headquarters: New Carrollton, MD
Overview
The Bizzell Group is seeking Underage Purchasers (ages 18–20) to assist in undercover tobacco compliance inspections at retail locations across North Carolina. This position plays a critical role in supporting federal and state regulatory enforcement by ensuring retailers comply with tobacco sales laws under the Family Smoking Prevention and Tobacco Control Act and the FDA Tobacco Inspection Program.
Age Requirement (Bona Fide Occupational Qualification – BFOQ):
Applicants must be between 18 and 20 years old at the time of application. This age requirement is legally necessary and qualifies as a BFOQ under federal anti-discrimination laws, as the role specifically involves attempting to purchase tobacco as a minor under the legal age of 21. Compliance operations require individuals who are under 21 to assess retailer adherence to federal and state regulations.
Key Responsibilities
Compliance Inspections
- Accompany an FDA-commissioned inspector to designated retail locations to assess compliance with tobacco sales regulations.
- Attempt to purchase tobacco products while strictly adhering to FDA compliance protocols and procedural guidelines.
- Maintain professionalism, confidentiality, and discretion to ensure unbiased compliance assessments.
Documentation & Reporting
- Provide detailed and accurate reports on each inspection, documenting interactions, retailer responses, and any observed violations.
- Ensure compliance with FDA and North Carolina Department of Health and Human Services (NC DHHS) regulations for the tobacco retail inspection program.
Training & Compliance Adherence
- Successfully complete all FDA-required training to ensure proper adherence to inspection protocols and compliance standards.
- Follow chain of custody procedures for any collected evidence.
- Participate in refresher training sessions and program evaluations as required by the FDA Tobacco Inspection Program.
Skills & Competencies
- Strong attention to detail and ability to strictly follow compliance protocols.
- Effective observational and communication skills for documenting inspection results.
- Ability to maintain confidentiality and professionalism in all inspection activities.
- Availability to work flexible hours and travel locally as required.
Why Join Us?
- Gain valuable experience in federal compliance enforcement and regulatory inspections.
- Contribute to public health and safety by ensuring compliance with tobacco control laws.
- Work as part of a highly trained team committed to upholding state and federal regulatory standards.
Interested candidates should submit their resume and application for consideration.
Eligibility Criteria
- Age Requirement (BFOQ Justification): Must be between 18 and 20 years old at the time of application. This is a legally required condition for performing job duties.
- Required to pass the NC state background check.
- Must have a valid driver’s license and reliable transportation for travel to assigned retail locations.
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