152 Fda jobs in Silver Spring

**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

**Description**
We are seeking an experienced and detail-oriented Quality Assurance (QA) Lead to oversee and drive quality assurance initiatives across products, services, and operational processes. The QA Lead will be responsible for developing and implementing quality standards and procedures to ensure compliance with internal benchmarks, customer expectations, contractual obligations, and applicable regulatory and industry standards. This role is critical in maintaining a culture of quality and continuous improvement throughout the organization.
**Primary Responsibilities** :
+ Develop and implement quality assurance policies, standards, and procedures to support consistent quality across all products and services.
+ Perform audits and inspections to evaluate compliance with established standards, including ISO, CMMI, and other applicable frameworks.
+ Conduct root cause analysis for quality issues and implement corrective and preventive actions (CAPAs).
+ Monitor processes, outputs, and systems to identify areas for improvement and collaborate with teams to develop and implement effective solutions.
+ Maintain quality assurance documentation, including protocols, process flows, and training materials.
+ Lead and support continuous improvement initiatives and drive best practices in quality management.
+ Track, analyze, and report on key quality metrics and present findings to senior management.
+ Provide QA training and mentorship to project teams, helping to foster a proactive quality culture.
+ Participate in project and process reviews to ensure quality considerations are integrated throughout the project lifecycle.
+ Ensure compliance with industry standards, regulations, and contractual requirements.
**Basic Qualifications**
+ TS/SCI w/ Poly Clearance is required
+ Bachelor's degree in Engineering, Computer Science, Quality Assurance, or a related technical field.
+ 4-8 years of experience in quality assurance, quality control, or product testing; or 2-6 years of experience with a Master's degree.
+ Proven experience developing, implementing, and maintaining QA/QC systems for technical products or systems.
+ Strong understanding of inspection, testing, and evaluation methods used to assess product quality and reliability.
+ Experience conducting integration, system, and performance testing.
+ Familiarity with test planning, test execution, and troubleshooting across product lifecycles.
+ Demonstrated ability to analyze failure trends and post-delivery feedback to identify root causes and recommend corrective actions.
+ Effective communication skills for collaboration with internal technical teams and clients.
**Preferred Qualifications**
+ Advanced knowledge of quality management standards (e.g., ISO 9001, Six Sigma, CMMI).
+ Experience with test automation frameworks and tools.
+ Proficiency in data analysis techniques for identifying process or product deviations and performance issues.
+ Familiarity with requirements analysis, software testing, and validation methodologies.
+ Prior experience in leading QA initiatives or managing quality projects.
+ Strong background in technical documentation and process improvement.
+ Ability to influence solution design and testing strategies across cross-functional teams.
+ Relevant professional certifications (e.g., ASQ Certified Quality Engineer, ISTQB, Six Sigma Green/Black Belt).
Come break things (in a good way). Then build them smarter.
We're the tech company everyone calls when things get weird. We don't wear capes (they're a safety hazard), but we do solve high-stakes problems with code, caffeine, and a healthy disregard for "how it's always been done."
**Original Posting:**
June 6, 2025
For U.S. Positions: While subject to change based on business needs, Leidos reasonably anticipates that this job requisition will remain open for at least 3 days with an anticipated close date of no earlier than 3 days after the original posting date as listed above.
**Pay Range:**
Pay Range $72,150.00 - $130,425.00
The Leidos pay range for this job level is a general guideline onlyand not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
REQNUMBER: R-
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.

Description

Provides assessment, evaluation and support for all quality initiatives within PHS Oregon. Provides concurrent and retrospective support managing initiatives to comply and in accordance with Center for Medicare and Medicaid requirements, The Joint Commission (TJC) requirements, administrative and program personnel, and third party payors. Actively works with physician leadership, Directors and Managers in the development and implementation of quality efforts, including preparation, risk monitoring and reduction in clinical and non-clinical systems, and coordination of multidisciplinary quality improvement projects. Acts as a facilitator and mentor for Department teams related to performance improvement. Authorizes and makes decisions on recommendations and innovative solutions. Serves as a resource and consultant for Quality Improvement activities and Professional Staff quality and peer review activities. Assists in development and performance of educational activities as related to Quality Improvement, Accreditation requirements, and Resource Utilization.

Providence caregivers are not simply valued – they’re invaluable. Join our team at Providence Oregon Regional Shared Services and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and retain the best people, we must empower them.

Required Qualifications:

• Bachelor's Degree Nursing.
• Upon hire: Oregon Registered Nurse License
• 5 years Clinical experience.
• 5 years Hospital experience in a progressively responsible position(s) requiring contact with various departments.
• Demonstrated clinical experience related to a wide variety of patient populations and care delivery models.
• Demonstrated leadership experience.
• Demonstrated experience in communicating effectively, both verbally and in writing, with physicians, nursing, public, and all levels of hospital management.

Preferred Qualifications:

• Master's Degree Nursing, Public Health, Business, Healthcare or Business Administration.
• Adult medical surgical experience.

Why Join Providence?

Our best-in-class benefits are uniquely designed to support you and your family in staying well, growing professionally, and achieving financial security. We take care of you, so you can focus on delivering our Mission of caring for everyone, especially the most vulnerable in our communities.

About Providence

At Providence, our strength lies in Our Promise of “Know me, care for me, ease my way.” Working at our family of organizations means that regardless of your role, we’ll walk alongside you in your career, supporting you so you can support others. We provide best-in-class benefits and we foster an inclusive workplace where diversity is valued, and everyone is essential, heard and respected. Together, our 120,000 caregivers (all employees) serve in over 50 hospitals, over 1,000 clinics and a full range of health and social services across Alaska, California, Montana, New Mexico, Oregon, Texas and Washington. As a comprehensive health care organization, we are serving more people, advancing best practices and continuing our more than 100-year tradition of serving the poor and vulnerable.

The amounts listed are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities.

Providence offers a comprehensive benefits package including a retirement 401(k) Savings Plan with employer matching, health care benefits (medical, dental, vision), life insurance, disability insurance, time off benefits (paid parental leave, vacations, holidays, health issues), voluntary benefits, well-being resources and much more. Learn more at providence.jobs/benefits.

Applicants in the Unincorporated County of Los Angeles: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Unincorporated Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act."

About the Team

Providence has been serving the Pacific Northwest since 1856 when Mother Joseph of the Sacred Heart and four other Sisters of Providence arrived in Vancouver, Washington Territory. As the largest healthcare system and largest private employer in Oregon, Providence is located in areas ranging from the Columbia Gorge to the wine country to sunny southern Oregon to charming coastal communities to the urban setting of Portland.

Our award-winning and comprehensive medical centers are known for outstanding programs in cancer, cardiology, neurosciences, orthopedics, women's services, emergency and trauma care, pediatrics and neonatal intensive care. Our not-for-profit network also provides a full spectrum of care with leading-edge diagnostics and treatment, outpatient health centers, physician groups and clinics, numerous outreach programs, and hospice and home care.

Providence is proud to be an Equal Opportunity Employer. We are committed to the principle that every workforce member has the right to work in surroundings that are free from all forms of unlawful discrimination and harassment on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law. We believe diversity makes us stronger, so we are dedicated to shaping an inclusive workforce, learning from each other, and creating equal opportunities for advancement.

Requsition ID:

Company: Providence Jobs

Job Category: Clinical Quality

Job Function: Quality/Process Improvements

Job Schedule: Full time

Job Shift: Day

Career Track: Nursing

Department: 5016 RS QUAL ASSURANCE

Address: OR Portland 9205 SW Barnes Rd

Work Location: Providence St Vincent Medical Ctr-Portland

Workplace Type: On-site

Pay Range: $49.34 - $76.59

The amounts listed are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities.

PandoLogic. Category:Healthcare, Keywords:Quality Assurance Nurse, Location:Vancouver, WA-98661

Job Details

Job Location
King George, VA

LPN (Quality Assurance)

At Heritage Hall, we regard patients as cherished members of our extended family. We prioritize providing both patients and their families with peace of mind, assuring them through our actions that their loved ones are under the attentive and capable care of our dedicated team.

Each of our centers reflects the culture and essence of the community it serves, and our team is wholeheartedly committed to treating patients and families with the same level of care and compassion we would offer our own loved ones.

Are you a dedicated Nurse leader who takes pride in managing and upholding protocols to guarantee the utmost quality of care for the community of residents? If so, we want to hear from you.

Full time position.

Qualifications

Qualifications:

• Must have ASN or BSN degree from an accredited college
• Must have an active RN or LPN license in the state of Virginia
• Five (5) years of supervisory or nursing administration experience preferred
• Experience in long-term care preferred
• Knowledge of nursing practices and procedures
• Knowledge of the laws, regulations and guidelines governing nursing functions in a long-term care facility
• Ability to plan, organize, develop, and implement programs
• Ability to work well with a variety of individuals
• Ability to communicate effectively both oral and written
• Ability to cope with mental and emotional stress

**JOB SUMMARY**
Responsible for inspecting the product to identify quality issues and assisting with product repacking as needed.
**The work shift for this position is 6:00 PM - 2:30 AM.**
**RESPONSIBILITIES**
+ Provide technical, customer relations, and personnel management for major programs and projects.
+ Conduct daily walk-through of assigned coolers to check the quality of the product and identify any quality issues.
+ Check dates of product for proper product rotation by date.
+ Remove any distressed product, determine what product needs reworking and what product should be discarded.
+ Rework all distressed/damaged products.
+ Communicate quality issues to buyers, management, and associates.
+ Report all lost products or transfers.
+ Assure that all inventory is properly blocked and labeled.
+ Assist in inventory counts.
+ Instructs handlers in the proper method of loading trucks.
+ All product loaded must be transported without damage
**QUALIFICATIONS**
**Education**
Prefer High School or GED
**Experience**
A minimum of two (2) years related experience (knowledge of produce industry preferred).
**Skills**
+ Ability to operate warehouse power equipment.
+ Ability to interact with others in a professional manner.
+ Good verbal and written communication skills.
+ General understanding of the shipping procedures of a high-volume warehouse operation.
+ Solid understanding of produce varieties handled in a wholesale operation.
**Decision Making Authority**
Most important decisions made fully independently:
Identifying quality issues,
Most important decisions made with review and approval of other individuals or supervisors (include the reviews/approvals required):
All work regularly reviewed by the supervisor and manager.
**Other Information**
+ Some stooping and bending required.
+ Ability to manually inspect produce efficiently for periods of up to or exceeding eight (8) hours.
+ They must be able to move around the work area freely.
+ Frequent lifting of the product up to 50 lbs. during the shift, infrequent lifting to 80 lbs.
+ External Job Posting
AFFIRMATIVE ACTION STATEMENT:
Applicants must be currently authorized to work in the United States. We are proud to be an Equal Opportunity and Affirmative Action employer, and consider qualified applicants without regard to race, color, creed, religion, ancestry, national origin, sex, sexual orientation, gender identity, age, disability, veteran status or any other protected factor under federal, state or local law. This opportunity is available through Sysco Corporation, its subsidiaries and affiliates.

In a world of possibilities, pursue one with endless opportunities. Imagine Next!
When it comes to what you want in your career, if you can imagine it, you can do it at Parsons. Imagine a career working with exceptional people sharing a common quest. Imagine a workplace where you can be yourself. Where you can thrive. Where you can find your next, right now. We've got what you're looking for.
**Job Description:**
Parsons is looking for a talented **QA Engineer** to join our growing team!
**What You'll Be Doing** :
+ Ensuring the security, reliability, and performance of our cloud-based solutions, which are integral to our operations and client services.
+ Designing and executing plans, executing rigorous testing protocols, and identifying potential vulnerabilities and performance issues
**What Required Skills You'll Bring** :
+ 3+ years of experience in quality assurance, particularly in large-scale cloud systems.
+ Bachelors degree in a relevant field
+ **Active TS/SCI with CI Poly**
+ Strong background in testing and validating complex systems that handle large quantities of sensitive cyber data
+ Deep understanding of cloud architecture, cybersecurity principles, and data protection regulations
**What Desired Skills You Might Bring** :
+ NC3 Mission Space experience
+ AWS Cloud certifications
**Security Clearance Requirement:**
An active Top Secret SCI w/Polygraph security clearance is required for this position.
This position is part of our Federal Solutions team.
The Federal Solutions segment delivers resources to our US government customers that ensure the success of missions around the globe. Our intelligent employees drive the state of the art as they provide services and solutions in the areas of defense, security, intelligence, infrastructure, and environmental. We promote a culture of excellence and close-knit teams that take pride in delivering, protecting, and sustaining our nation's most critical assets, from Earth to cyberspace. Throughout the company, our people are anticipating what's next to deliver the solutions our customers need now.
Salary Range: $86,700.00 - $151,700.00
We value our employees and want our employees to take care of their overall wellbeing, which is why we offer best-in-class benefits such as medical, dental, vision, paid time off, 401(k), life insurance, flexible work schedules, and holidays to fit your busy lifestyle!
Parsons is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, veteran status or any other protected status.
We truly invest and care about our employee's wellbeing and provide endless growth opportunities as the sky is the limit, so aim for the stars! Imagine next and join the Parsons quest-APPLY TODAY!
Parsons is aware of fraudulent recruitment practices. To learn more about recruitment fraud and how to report it, please refer to .
About Us
Parsons is a digitally enabled solutions provider focused on the defense, security, and infrastructure markets. With nearly 75 years of experience, Parsons is uniquely qualified to deliver cyber/converged security, technology-based intellectual property, and other innovative services to federal, regional, and local government agencies, as well as to private industrial customers worldwide.
Parsons is an equal opportunity, drug-free employer committed to diversity in the workplace. Minority/Female/Disabled/Protected Veteran/LGBTQ+.
For more about Parsons, visit parsons.com and follow us on Facebook, Twitter, LinkedIn, and YouTube.

**Description**
The National Security Sector of Leidos has a career opportunity for a talented **Quality Assurance Manager** to support a program in the Cyber & Analytics Business Area. This position serves as the member of a team with the responsibility to ensure the highest quality service is provided to our customer through the generation and control of program processes, performance of regularly scheduled internal process audits and the consistent facilitation of structured improvement activities. The successful candidate will be an agent for change, possess high energy, have a passion for quality, and be self-motivated. The environment demands the ability to quickly establish working relationships with coworkers/customers in various national capital region locations.
**PRIMARY RESPONSIBILITIES:**
+ Manage program instantiation of the Quality Management System (QMS)
+ Deploy and implement appropriate QMS processes
+ Integrate closely with the program team to implement and execute the QMS
+ Recommend, facilitate, track and report on continuous process improvement activities
+ Implement audit practices for internal processes and products
+ Ensure adherence to all standards, Leidos policies, and best practices
+ Support the development and collection of performance metrics
+ Track, analyze and report to program management on trends found in the performance metrics
+ Provide the program manager with timely metrics and audit outcomes to gauge progress towards quality objectives
+ Report to higher level management on Quality Achievement and act as liaison for enterprise quality initiatives for the program.
+ Review and submit contract deliverables
+ Ensure compliance with PWS, QASP, EENG, ISO (namely 9001:2015) for the program as applicable
+ Create, update, adopt a Tailored Process Baseline (TPB) for the program as applicable
+ Document and work to resolve nonconformities and requirement escapes via root cause analysis and corrective/preventive action
+ Support Leidos reporting, such as Quality Management Reviews, In Process Reviews, Weekly Activity Reports, and Monthly Operational Reviews
+ Other duties as required
**BASIC QUALIFICATIONS:**
+ BA degree and 10 years of relevant experience or Masters with 8 years of prior relevant experience.
+ Experience providing Quality Management with Software Development and IT Service Management Projects
+ Lean Six-Sigma Green Belt
+ Experience auditing to external quality standards such as ISO9001/ISO2000/AS9100/CMMI Dev or Svc
+ Experienced with peer reviews and process auditing
+ Experience collecting and analyzing metrics
+ Ability to multi-task, complete tasks without direct supervision, and function in a dynamic, fast-paced environment
+ Excellent verbal and written skills
+ Proficiency with MS Office Products (Word, Excel, Visio, PowerPoint, & Project)
+ Ability to support limited domestic travel
+ Security Clearance Requirement: Active Top Secret/SCI clearance with polygraph
**PREFERRED QUALIFICATIONS:**
+ Certified Lean Six-Sigma Black Belt
+ Experience with Agile principles
+ Understanding of ITIL principles (ITIL Foundation training or equivalent)
+ Formal auditor training
conmd
**Original Posting:**
February 12, 2025
For U.S. Positions: While subject to change based on business needs, Leidos reasonably anticipates that this job requisition will remain open for at least 3 days with an anticipated close date of no earlier than 3 days after the original posting date as listed above.
**Pay Range:**
Pay Range $89,700.00 - $162,150.00
The Leidos pay range for this job level is a general guideline onlyand not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
REQNUMBER: R-
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Leidos will consider qualified applicants with criminal histories for employment in accordance with relevant Laws. Leidos is an equal opportunity employer/disability/vet.

**Job Family** **:**
Scientific Research & Analysis (Digital)
**Travel Required** **:**
None
**Clearance Required** **:**
Ability to Obtain Public Trust
We are currently searching for a QA Specialist to provide support to the National Institutes of Health (NIH), Department of Laboratory Medicine (DLM). This is a full-time opportunity based in Bethesda, MD.
**What You Will Do** **:**
+ Review records related to the general operation and upkeep of a GMP Quality Control laboratory, including but not limited to, QC test data, Quality Event (QE) documents, qualification documents, and validations.
+ Receive, log, and release incoming supplies and material to the Quality Control laboratory.
+ Support the maintenance of the document control system, including formatting, numbering, and scanning of records into the Document Management System (DMS).
+ Support the maintenance of the Equipment Control and Service program, including but not limited to, on-boarding of new equipment, maintaining calibration/preventative maintenance records, updating the equipment database, and notifying the laboratory of pending calibration/preventative maintenance activities.
+ Support the maintenance of the CAPA, Deviation, Environmental Excursion, Investigations, and Change Control programs.
+ Support the maintenance of the Internal and External Audit program, with guidance from Management.
+ Track, analyze, and report on Quality Performance Indicators (QPIs).
+ Provides QA support and oversight for the resolution of CAPA, Deviations, Environmental Excursions, and Change Control.
+ Act as QA reviewer for investigations, deviations, and CAPA; with limited approval authority as designated by QA Management.
+ Participates in Internal Audits to ensure continued adherence to internal procedures and industry best practices.
+ Participate in the GMP training of new employees and contractors, as required.
+ Participates in root cause analysis using methods such as Ishikawa diagrams, 5 Whys, comparative analysis, and process flow charting, as required.
+ Identify and drive system improvements, both within Quality Assurance and for laboratory operations, to effectively accomplish the goals or strategies of the Service and to maximize quality and productivity of the Service.
+ Independently develop, write, and lead the implementation of controlled documents (i.e. SOPs, Policies, Protocols) which may entail significant system changes.
+ Stay current with changes to current Good Manufacturing Practices, as they relate to manufacturing of clinical trial material (Phase 1 - Phase 3), Positron Emission Tomography (PET) drugs, and compounding pharmacies.
+ Follow established policies and procedures and apply applicable regulations based on assignment, such as GMP, CFR, and ICH regulations.
**What You Will Need** **:**
+ Bachelor's degree with a minimum of SEVEN (7) years of experience in quality assurance and/or quality control in a clinical laboratory environment.
+ Knowledge of cGMP, aseptic processing, and microbiology is required.
+ Ability to lift 10 - 30 pounds.
+ Excellent hand-eye coordination.
+ Strong communications skills, both oral and written.
+ Excellent analytical, organizational and time management skills.
+ Ability to rapidly adapt to changing environment and circumstances.
+ Ability to work effectively in a team environment.
+ Must be able to OBTAIN and MAINTAIN a Federal or DoD "PUBLIC TRUST"; candidates must obtain approved adjudication of their PUBLIC TRUST prior to onboarding with Guidehouse. Candidates with an ACTIVE PUBLIC TRUST or SUITABILITY are preferred.
**What Would Be Nice To Have** **:**
+ Preferred fields of study: Microbiology, Biological Science, or a related discipline.
+ Prior experience supporting NIH a plus.
The annual salary range for this position is $85,000.00-$141,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.
**What We Offer:**
Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.
Benefits include:
+ Medical, Rx, Dental & Vision Insurance
+ Personal and Family Sick Time & Company Paid Holidays
+ Parental Leave
+ 401(k) Retirement Plan
+ Group Term Life and Travel Assistance
+ Voluntary Life and AD&D Insurance
+ Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts
+ Transit and Parking Commuter Benefits
+ Short-Term & Long-Term Disability
+ Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
+ Employee Referral Program
+ Corporate Sponsored Events & Community Outreach
+ Care.com annual membership
+ Employee Assistance Program
+ Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
+ Position may be eligible for a discretionary variable incentive bonus
**About Guidehouse**
Guidehouse is an Equal Opportunity Employer-Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.
Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.
If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at or via email at . All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.
All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or . Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.
If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse's Ethics Hotline. If you want to check the validity of correspondence you have received, please contact . Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant's dealings with unauthorized third parties.
_Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee._

Datavant is a data platform company and the world's leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format.
Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care.
By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare.
**What We're Looking For:**
We are seeking a Quality Assurance Auditor to ensure operational effectiveness, regulatory compliance, and continuous process improvement across medical records workflows. This role is critical to safeguarding patient information, ensuring adherence to HIPAA and regulatory standards, and supporting process enhancements that improve accuracy, efficiency, and compliance.
**What You Will Do:**
Work remotely from anywhere in the United States
+ **Audit & Quality Control:**
+ Review the accuracy of pended requests to confirm medical records in HealthSource are captured correctly.
+ Perform quality checks to ensure compliance with HIPAA, state/federal laws, client-specific requirements, and invoicing standards.
+ Identify workflow issues, error trends, and delays; recommend corrective actions to leadership.
+ Conduct audits of request and fulfillment processes to verify adherence to Standard Operating Procedures (SOPs).
+ Maintain thorough documentation of audit results, findings, and corrective actions.
+ Stay up to date on laws, fee structures, and facility policies governing the release of information.
+ **Process Improvement:**
+ Recommend and assist with process enhancements to increase efficiency and accuracy.
+ Collaborate with training and operations teams to address recurring issues and contribute to updated training materials or job aids.
+ **Compliance Monitoring:**
+ Ensure all requests meet HIPAA, HITECH, and other applicable regulatory standards for handling and releasing Protected Health Information (PHI).
+ Monitor adherence to client-specific service-level agreements (SLAs) and protocols.
+ **Training & Support:**
+ Provide feedback to team members based on audit outcomes.
+ Support onboarding and ongoing QA training for new hires focused on documentation accuracy and compliance.
+ Participate in required training sessions, staff meetings, and professional development activities.
+ Participate in monthly interrater reliability training with the Quality Assurance Audit Manager and team.
**What a Typical Day Looks Like**
In this role, you can expect to:
+ Collaborate with the quality team and cross-functional partners in operations, compliance, training, and data.
+ Conduct audits, capture results, and analyze trends.
+ Report findings to the Quality Assurance Audit Manager and recommend improvements.
+ Provide feedback and support to operational teams to ensure quality and compliance goals are met.
**What You Need to Succeed:**
+ **Experience:** Minimum 5 years in Release of Information (ROI) or health information operations (Datavant experience strongly preferred).
+ **Auditing Skills:** 1+ years in quality assurance or auditing with proven ability to evaluate processes, identify gaps, and recommend solutions.
+ **Education:** High school diploma required; Associate's or Bachelor's degree in Health Information Management, Healthcare Administration, or related field strongly preferred.
+ **Knowledge:** In-depth understanding of HIPAA, PHI handling standards, and medical record confidentiality.
+ **Technical Skills:** Proficiency in electronic health record (EHR) systems, request tracking tools, and Microsoft Office.
+ **Soft Skills:** Strong attention to detail, excellent communication, organizational skills, and the ability to problem-solve in a fast-paced environment.
+ **Professionalism:** Maintains confidentiality, strong rapport with colleagues, and forward-thinking approach to challenges.
**Analytical Skills:** Ability to analyze data and deliver actionable insights.
Pay ranges for this job title may differ based on location, responsibilities, skills, experience, and other requirements of the role.
The estimated base pay range per hour for this role is:
$21-$25 USD
To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion.
This job is not eligible for employment sponsorship.
Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here ( . Know Your Rights ( , explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay.
At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way.
Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, ( by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here ( . Requests for reasonable accommodations will be reviewed on a case-by-case basis.
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