H-1B Visa Quality Control Coordinator Jobs
H-1B visa jobs for Quality Control Coordinators are available at manufacturers, pharmaceutical companies, and food processing firms that file Labor Condition Applications for degree-holding QC professionals. Employers sponsor H-1B status for up to three years, with extensions available, when the role requires a bachelor's degree in a directly related field such as chemistry, engineering, or life sciences.
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Get Access To All JobsINTRODUCTION
Georgetown University comprises two unique campuses in the nation’s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.
ABOUT THE JOB
The Lombardi Clinical Trials Office (CTO) is a shared institutional resource of the Lombardi Comprehensive Cancer Center (LCCC) at Georgetown University. It provides administrative and clinical operations support for cancer clinical trials conducted by Lombardi investigators.
Reporting directly to the Lombardi CTO Training, Education, and Quality Control (TEQC) Manager, the Quality Control Coordinator 1 interfaces with clinical research faculty and staff in the execution and maintenance of a comprehensive cancer clinical research quality control program across LCCC’s NCI Cancer Center Support Grant (CCSG) consortium sites. This position works in close coordination with LCCC consortium clinical research teams as well as the leadership and staff within the Georgetown University Medical Center (GUMC) Office of Research Quality Assurance (ORQA).
The Quality Control Coordinator 1 performs study- and staff-level quality assessments to verify adherence to Lombardi CTO Guidance Documents, joint GUMC and MedStar Health Standard Operating Procedures (SOPs), and applicable federal, state, and institutional regulatory standards. Through proactive quality monitoring and audit support activities, the Quality Control Coordinator 1 plays an essential role in evaluating protocol compliance, supporting staff competency, and promoting audit readiness across all LCCC cancer clinical research studies.
Responsibilities
Key responsibilities include, but are not limited to:
- Performing quality control assessments and risk-based centralized eligibility reviews for select cancer clinical trials (e.g., NCTN).
- Conducting regular quality reviews within the Clinical Trials Management System (CTMS; OnCore) to assure data integrity and SOP compliance.
- Assisting in the coordination, preparation, conduct, and follow-up for internal quality monitoring and external audits across LCCC consortium sites.
- Collaborating with ORQA and the TEQC Manager to review audit findings and identify systemic trends to inform future training and educational initiatives.
- Assisting with the maintenance of Lombardi CTO Standard Operating Procedures and Guidance Documents to support uniform research practices.
The Quality Control Coordinator 1 is expected to perform all duties in accordance with applicable laws and regulations and adhere to Georgetown University Medical Center’s philosophies, policies, and SOPs, as well as work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and Good Clinical Practice (GCP) guidelines.
BASIC QUALIFICATIONS
Required Knowledge, Skills, and Abilities
- Regulatory & Quality Compliance: Working knowledge of regulations governing clinical research conduct (FDA, Human Subject Protection, Good Clinical Practice [GCP], and International Council for Harmonisation [ICH] guidelines).
- Oncology Research Operations: Foundational understanding of medical and clinical research terminology, protocol visit structures, and clinical trial workflows, preferably within oncology therapeutic research.
- Quality Assurance Principles: Understanding of quality control reviews, source document verification, centralized eligibility screening, and audit preparation processes.
- Attention to Detail & Analytical Skills: Proven ability to review clinical research records accurately, identify protocol discrepancies or compliance gaps, and document findings clearly.
- Organization & Time Management: Strong organizational and problem-solving skills, with the ability to prioritize competing tasks and deliver high-quality results within defined timelines.
- Communication & Interpersonal Skills: Strong verbal, written, and presentation skills to effectively communicate compliance feedback, collaborate with study teams, and maintain effective working relationships with supervisors, peers, and internal stakeholders.
- Technical Proficiency: Proficiency with technology applications, including Microsoft Office (Word, Excel, PowerPoint), Google Workspace, and Clinical Trial Management Systems (CTMS; OnCore).
WORK INTERACTIONS
This position reports directly to the Lombardi CTO Training, Education, and Quality Control Manager. The Quality Control Coordinator 1 interacts regularly with:
- Lombardi CTO Leadership & Management: Administrative Director, TEQC Manager, and Lombardi CTO Functional Area Managers.
- Lombardi CTO TEQC Team Members: Quality Control Coordinator(s).
- Lombardi CTO Functional Teams: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians, and IIT Office staff.
- LCCC Consortium Teams: Principal Investigators, physicians, and clinical research personnel across GUMC and consortium sites.
- Institutional Departments & Staff: Georgetown Office of Research Quality Assurance (ORQA), Institutional Review Board (IRB), Clinical Trials Business Office, MedStar Health Research Institute (MHRI), and MedStar hospital staff (e.g., Infusion Nurses, Oncology Pharmacists).
- External Entities: Clinical trial sponsors, external monitors, and regulatory inspectors.
MINIMUM QUALIFICATIONS
Required:
- Bachelor’s degree in a biological science, health science, or related field.
- Ability to perform light travel to consortium sites, as needed.
PREFERRED QUALIFICATIONS
- Up to two (2) years of clinical research experience, preferably in oncology clinical trials.
- Knowledge of or prior experience with NCI Cancer Center Support Grant (CCSG) guidelines and expectations.
- Society of Clinical Research Associates (SOCRA / CCRP) or Association of Clinical Research Professionals (ACRP / CCRC / CCRA) certification.
WORK MODE DESIGNATION
This position has been designated as Hybrid. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position’s mode of work designation. Complete details about Georgetown University’s mode of work designations for staff positions can be found on the Department of Human Resources website.
PAY RANGE
The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:
$44,022.00 - $73,406.80
Compensation is determined by a number of factors including, but not limited to, the candidate’s individual qualifications, experience, education, skills, and certifications, as well as the University’s business needs and external factors.
CURRENT GEORGETOWN EMPLOYEES
If you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.
SUBMISSION GUIDELINES
Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions.
NEED ASSISTANCE
If you are a qualified individual with a disability and need a reasonable accommodations for any part of the application and hiring process, please visit the Office for Equal Opportunity Compliance website for general information about requesting accommodations, as well as information about requesting accommodations specifically for applicants. You also can also contact the Office for Equal Opportunity Compliance at (202) 687-4798 or oeoc@georgetown.edu.
Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website.
GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law.
BENEFITS
Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.
INTRODUCTION
Georgetown University comprises two unique campuses in the nation’s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.
ABOUT THE JOB
The Lombardi Clinical Trials Office (CTO) is a shared institutional resource of the Lombardi Comprehensive Cancer Center (LCCC) at Georgetown University. It provides administrative and clinical operations support for cancer clinical trials conducted by Lombardi investigators.
Reporting directly to the Lombardi CTO Training, Education, and Quality Control (TEQC) Manager, the Quality Control Coordinator 1 interfaces with clinical research faculty and staff in the execution and maintenance of a comprehensive cancer clinical research quality control program across LCCC’s NCI Cancer Center Support Grant (CCSG) consortium sites. This position works in close coordination with LCCC consortium clinical research teams as well as the leadership and staff within the Georgetown University Medical Center (GUMC) Office of Research Quality Assurance (ORQA).
The Quality Control Coordinator 1 performs study- and staff-level quality assessments to verify adherence to Lombardi CTO Guidance Documents, joint GUMC and MedStar Health Standard Operating Procedures (SOPs), and applicable federal, state, and institutional regulatory standards. Through proactive quality monitoring and audit support activities, the Quality Control Coordinator 1 plays an essential role in evaluating protocol compliance, supporting staff competency, and promoting audit readiness across all LCCC cancer clinical research studies.
Responsibilities
Key responsibilities include, but are not limited to:
- Performing quality control assessments and risk-based centralized eligibility reviews for select cancer clinical trials (e.g., NCTN).
- Conducting regular quality reviews within the Clinical Trials Management System (CTMS; OnCore) to assure data integrity and SOP compliance.
- Assisting in the coordination, preparation, conduct, and follow-up for internal quality monitoring and external audits across LCCC consortium sites.
- Collaborating with ORQA and the TEQC Manager to review audit findings and identify systemic trends to inform future training and educational initiatives.
- Assisting with the maintenance of Lombardi CTO Standard Operating Procedures and Guidance Documents to support uniform research practices.
The Quality Control Coordinator 1 is expected to perform all duties in accordance with applicable laws and regulations and adhere to Georgetown University Medical Center’s philosophies, policies, and SOPs, as well as work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and Good Clinical Practice (GCP) guidelines.
BASIC QUALIFICATIONS
Required Knowledge, Skills, and Abilities
- Regulatory & Quality Compliance: Working knowledge of regulations governing clinical research conduct (FDA, Human Subject Protection, Good Clinical Practice [GCP], and International Council for Harmonisation [ICH] guidelines).
- Oncology Research Operations: Foundational understanding of medical and clinical research terminology, protocol visit structures, and clinical trial workflows, preferably within oncology therapeutic research.
- Quality Assurance Principles: Understanding of quality control reviews, source document verification, centralized eligibility screening, and audit preparation processes.
- Attention to Detail & Analytical Skills: Proven ability to review clinical research records accurately, identify protocol discrepancies or compliance gaps, and document findings clearly.
- Organization & Time Management: Strong organizational and problem-solving skills, with the ability to prioritize competing tasks and deliver high-quality results within defined timelines.
- Communication & Interpersonal Skills: Strong verbal, written, and presentation skills to effectively communicate compliance feedback, collaborate with study teams, and maintain effective working relationships with supervisors, peers, and internal stakeholders.
- Technical Proficiency: Proficiency with technology applications, including Microsoft Office (Word, Excel, PowerPoint), Google Workspace, and Clinical Trial Management Systems (CTMS; OnCore).
WORK INTERACTIONS
This position reports directly to the Lombardi CTO Training, Education, and Quality Control Manager. The Quality Control Coordinator 1 interacts regularly with:
- Lombardi CTO Leadership & Management: Administrative Director, TEQC Manager, and Lombardi CTO Functional Area Managers.
- Lombardi CTO TEQC Team Members: Quality Control Coordinator(s).
- Lombardi CTO Functional Teams: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians, and IIT Office staff.
- LCCC Consortium Teams: Principal Investigators, physicians, and clinical research personnel across GUMC and consortium sites.
- Institutional Departments & Staff: Georgetown Office of Research Quality Assurance (ORQA), Institutional Review Board (IRB), Clinical Trials Business Office, MedStar Health Research Institute (MHRI), and MedStar hospital staff (e.g., Infusion Nurses, Oncology Pharmacists).
- External Entities: Clinical trial sponsors, external monitors, and regulatory inspectors.
MINIMUM QUALIFICATIONS
Required:
- Bachelor’s degree in a biological science, health science, or related field.
- Ability to perform light travel to consortium sites, as needed.
PREFERRED QUALIFICATIONS
- Up to two (2) years of clinical research experience, preferably in oncology clinical trials.
- Knowledge of or prior experience with NCI Cancer Center Support Grant (CCSG) guidelines and expectations.
- Society of Clinical Research Associates (SOCRA / CCRP) or Association of Clinical Research Professionals (ACRP / CCRC / CCRA) certification.
WORK MODE DESIGNATION
This position has been designated as Hybrid. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position’s mode of work designation. Complete details about Georgetown University’s mode of work designations for staff positions can be found on the Department of Human Resources website.
PAY RANGE
The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:
$44,022.00 - $73,406.80
Compensation is determined by a number of factors including, but not limited to, the candidate’s individual qualifications, experience, education, skills, and certifications, as well as the University’s business needs and external factors.
CURRENT GEORGETOWN EMPLOYEES
If you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.
SUBMISSION GUIDELINES
Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions.
NEED ASSISTANCE
If you are a qualified individual with a disability and need a reasonable accommodations for any part of the application and hiring process, please visit the Office for Equal Opportunity Compliance website for general information about requesting accommodations, as well as information about requesting accommodations specifically for applicants. You also can also contact the Office for Equal Opportunity Compliance at (202) 687-4798 or oeoc@georgetown.edu.
Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website.
GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law.
BENEFITS
Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.
See all H-1B Visa Quality Control Coordinator Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Quality Control Coordinator
Align your degree to the role
Quality Control Coordinator positions qualify as specialty occupations when the employer documents that the role requires a bachelor's degree in a specific field like chemistry, industrial engineering, or food science. Pull your credential evaluation early so it matches the SOC code the employer uses on the LCA.
Look up prevailing wages before negotiating
Use the OFLC Wage Search to find the wage level for your exact SOC code and worksite county before you discuss salary. Your employer must pay at least the prevailing wage on the certified LCA, so knowing Level I through Level IV thresholds protects you in the offer conversation.
Find sponsors on Migrate Mate by role
Search Migrate Mate to browse Quality Control Coordinator openings at employers with verified H-1B visa LCA filing history. Focusing on companies that have filed for this occupation before cuts the time you spend educating unfamiliar HR teams on the process.
Confirm each worksite has its own LCA
If your QC role requires rotating between production facilities or client sites, each worksite location needs its own certified LCA before you work there. Flag multi-site arrangements to your employer's immigration counsel during the offer stage, not after you've already started traveling.
Target regulated industries with consistent sponsorship
Pharmaceutical manufacturers, FDA-regulated food producers, and medical device companies file H-1B petitions for QC roles more consistently than general manufacturing because their quality systems require documented degree-level oversight. O*NET lists the analytical and regulatory tasks that support the specialty occupation argument for this occupation code.
Use your 60-day grace period strategically
If your current H-1B employer ends your position, USCIS allows a 60-day grace period to find a new sponsoring employer and file a transfer petition. Start the LCA process with the new employer immediately since DOL certification alone can take several business days before the I-129 can be filed.
H-1B Visa Quality Control Coordinator: Frequently Asked Questions
Does a Quality Control Coordinator role qualify as an H-1B specialty occupation?
It depends on how the employer structures the position. When the job duties center on designing quality systems, interpreting regulatory standards, or applying statistical process control, and the employer requires a bachelor's degree in chemistry, engineering, food science, or a related field, the role typically qualifies. Positions that primarily involve inspection checklists or administrative tracking without degree-level analysis are harder to support. Employers in pharmaceutical, medical device, and FDA-regulated food industries most reliably structure QC Coordinator roles to meet the specialty occupation standard.
Which industries most commonly sponsor H-1B visas for Quality Control Coordinators?
Pharmaceutical manufacturers, biotech firms, medical device companies, and FDA-regulated food and beverage producers file H-1B petitions for QC Coordinators most consistently. These industries require documented compliance with federal quality standards like cGMP and ISO 13485, which creates a clear need for degree-holding professionals. You can browse employers with verified H-1B LCA filing history for this occupation on Migrate Mate.
How does the LCA process work for Quality Control Coordinator positions?
Your employer files a Labor Condition Application with DOL through the FLAG system before submitting your H-1B petition to USCIS. The LCA certifies that the employer will pay at least the prevailing wage for your role and worksite location. Each facility where you perform QC duties requires its own certified LCA. DOL typically certifies LCAs within seven business days, but your employer must also post a public notice at the worksite for ten consecutive business days during that period.
Can a Quality Control Coordinator job support an H-1B transfer to a new employer?
Yes. Under H-1B portability rules, you can begin working for a new sponsoring employer as soon as the transfer petition is filed with USCIS, without waiting for approval, as long as you've maintained valid H-1B status and the new employer files before your current status expires. The new employer must complete a fresh LCA certification for the new worksite before filing the I-129 petition. Any worksite differences between your old and new positions need to be addressed in the new LCA.
What documents should I gather before applying for H-1B sponsored QC Coordinator roles?
Collect your academic transcripts, degree certificates, and a credential evaluation from a NACES-member organization if your degree is from outside the United States. You'll also want an updated resume that maps your experience directly to quality systems, regulatory compliance, or laboratory analysis rather than general coordination tasks. Having the O*NET occupation profile for Quality Control Coordinators on hand helps you discuss how your background aligns with the specialty occupation criteria when talking with employers or immigration counsel.