H-1B Visa Quality Control Specialist Jobs
Quality Control Specialist roles qualify for H-1B sponsorship when the position requires a bachelor's degree in a relevant field such as engineering, chemistry, or materials science. Employers in manufacturing, pharmaceuticals, and medical devices regularly file LCAs for these roles, making them a reliable category for H-1B job seekers.
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CTSI CLINICAL RESEARCH SERVICE (IN-PCIR-IUINA)
Job Summary
The Clinical Quality Assurance Specialist is responsible for the functions of the Indiana Clinical and Translational Science Institute (CTSI) Clinical Research Centers (CRCs) and other CTSI cores as time allows. This position ensures the planning, coordination, control, and continuous improvement of processes and methods established to control the quality of clinical research studies conducted at the Indiana CTSI; furthermore, the Clinical Quality Assurance Specialist ensures adherence to agency regulations (FDA), Good Clinical Practices (GCP) industry guidelines, local regulations and Indiana University (IU) policies and procedures for the conduct of clinical research studies. This position works closely with Clinical Operations, Clinical Translation Science Laboratory (CTSL), Information Technology, and other supporting areas (e.g., Indiana University Health University Hospital including Investigational Drug Pharmacy-IDS, Riley Hospital and Goodman Hall) to help ensure active participation in continuous quality improvement activities.
General Responsibilities
- Develops and implements moderately complex project plans consistent with the requirements of current and new federal, state, and local regulations and statutes as well as the compliance policies of the university.
- Manages implemented project plans including maintenance of program documentation, performance of training, monitoring and auditing.
- Collaborates with key research and operational stakeholders at IU to identify research compliance gaps, find solutions to mitigate risks and implement project plans.
- Continuously monitors regulatory changes and determine impact on research community.
- Collaborates with the research community to disseminate information and develop solutions to address regulatory requirements and contribute to compliance decision making.
- Expands knowledge by managing and participating in various committee meetings and attending workshops and conferences.
Qualifications
Required
- Bachelor's degree (preferably in business, health services, or a related field).
Work Experience
Required
- 3 years of relevant work experience in a sponsored research, compliance, healthcare, or clinical setting.
Skills
Required
- Demonstrates ability to maintain confidential information.
- Demonstrates analytical skills.
- Excellent organizational skills.
- Proficient written and verbal communication skills.
- Demonstrates excellent judgment and decision making skills.
- Experience in a regulated environment.
- Excellent collaboration and team building skills.
- Maintains composure under pressure.
- Ability to work within tight time frames and meet strict deadlines.
Working Conditions / Demands
This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment and the campus. The person in this role must be able to perform the essential functions with or without an accommodation.
Work Location
Indianapolis, Indiana
Benefits Overview
For full-time staff employees, Indiana University offers a wide array of benefits including:
- Comprehensive medical and dental insurance
- Health savings account with generous IU contributions
- Healthcare and dependent care flexible spending accounts
- Basic group life insurance paid by IU
- Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death and dismemberment insurance
- Base retirement plan with generous IU contributions, subject to vesting
- Voluntary supplemental retirement plan options
- Tuition subsidy for employees and family members taking IU courses
- 10 paid holidays plus a paid winter break each year
- Generous paid time off plans
- Paid leave for new parents and IU-sponsored volunteer events
- Employee assistance program (EAP)
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.
Job Classification
Career Level: Career
FLSA: Exempt
Job Function: Research
Job Family: Research Compliance
Click here to learn more about Indiana University's Job Framework.
Posting Disclaimer
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
Equal Employment Opportunity
Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.
Campus Safety and Security
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.
Contact Us
Request Support
Telephone: 812-856-1234
Department
CTSI CLINICAL RESEARCH SERVICE (IN-PCIR-IUINA)
Job Summary
The Clinical Quality Assurance Specialist is responsible for the functions of the Indiana Clinical and Translational Science Institute (CTSI) Clinical Research Centers (CRCs) and other CTSI cores as time allows. This position ensures the planning, coordination, control, and continuous improvement of processes and methods established to control the quality of clinical research studies conducted at the Indiana CTSI; furthermore, the Clinical Quality Assurance Specialist ensures adherence to agency regulations (FDA), Good Clinical Practices (GCP) industry guidelines, local regulations and Indiana University (IU) policies and procedures for the conduct of clinical research studies. This position works closely with Clinical Operations, Clinical Translation Science Laboratory (CTSL), Information Technology, and other supporting areas (e.g., Indiana University Health University Hospital including Investigational Drug Pharmacy-IDS, Riley Hospital and Goodman Hall) to help ensure active participation in continuous quality improvement activities.
General Responsibilities
- Develops and implements moderately complex project plans consistent with the requirements of current and new federal, state, and local regulations and statutes as well as the compliance policies of the university.
- Manages implemented project plans including maintenance of program documentation, performance of training, monitoring and auditing.
- Collaborates with key research and operational stakeholders at IU to identify research compliance gaps, find solutions to mitigate risks and implement project plans.
- Continuously monitors regulatory changes and determine impact on research community.
- Collaborates with the research community to disseminate information and develop solutions to address regulatory requirements and contribute to compliance decision making.
- Expands knowledge by managing and participating in various committee meetings and attending workshops and conferences.
Qualifications
Required
- Bachelor's degree (preferably in business, health services, or a related field).
Work Experience
Required
- 3 years of relevant work experience in a sponsored research, compliance, healthcare, or clinical setting.
Skills
Required
- Demonstrates ability to maintain confidential information.
- Demonstrates analytical skills.
- Excellent organizational skills.
- Proficient written and verbal communication skills.
- Demonstrates excellent judgment and decision making skills.
- Experience in a regulated environment.
- Excellent collaboration and team building skills.
- Maintains composure under pressure.
- Ability to work within tight time frames and meet strict deadlines.
Working Conditions / Demands
This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment and the campus. The person in this role must be able to perform the essential functions with or without an accommodation.
Work Location
Indianapolis, Indiana
Benefits Overview
For full-time staff employees, Indiana University offers a wide array of benefits including:
- Comprehensive medical and dental insurance
- Health savings account with generous IU contributions
- Healthcare and dependent care flexible spending accounts
- Basic group life insurance paid by IU
- Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death and dismemberment insurance
- Base retirement plan with generous IU contributions, subject to vesting
- Voluntary supplemental retirement plan options
- Tuition subsidy for employees and family members taking IU courses
- 10 paid holidays plus a paid winter break each year
- Generous paid time off plans
- Paid leave for new parents and IU-sponsored volunteer events
- Employee assistance program (EAP)
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.
Job Classification
Career Level: Career
FLSA: Exempt
Job Function: Research
Job Family: Research Compliance
Click here to learn more about Indiana University's Job Framework.
Posting Disclaimer
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
Equal Employment Opportunity
Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.
Campus Safety and Security
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.
Contact Us
Request Support
Telephone: 812-856-1234
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Quality Control Specialist
Match your degree to the role
H-1B approval for QC Specialist roles depends on your degree field directly matching the job duties. Engineering, chemistry, biology, and materials science degrees consistently satisfy specialty occupation requirements. A general business degree rarely does, so tailor your applications accordingly.
Target industries with consistent LCA filings
Pharmaceutical manufacturers, medical device companies, and semiconductor fabs file LCAs for QC Specialists at far higher rates than general manufacturing. Use OFLC Wage Search to filter by SOC code 51-9061 and identify which industries file most frequently in your target region.
Verify employer E-Verify enrollment before applying
Your employer must be E-Verify enrolled to petition for your H-1B. QC roles in federal contractor supply chains are often already enrolled, but smaller contract manufacturers may not be. Confirm enrollment status during the interview stage, not after an offer arrives.
Find QC employers sponsoring H-1B visas on Migrate Mate
Search Migrate Mate to surface QC Specialist roles at employers with verified H-1B LCA filing history. Filtering by filing activity removes employers who've never navigated sponsorship, saving you from offers that stall at the petition stage.
Align your start date with the H-1B cap timeline
Cap-subject H-1B petitions have an October 1 employment start date. If you're interviewing in late fall or winter, your actual start date could be 12 to 18 months away. Discuss this timeline with employers early so both sides plan the offer and onboarding around the cap schedule.
Document quality certifications before the I-129 is filed
ASQ certifications, ISO auditor credentials, and Six Sigma belt levels strengthen your specialty occupation argument in the I-129 petition. Gather official certificates and letters of verification before your employer files, since USCIS may request them in an RFE.
Quality Control Specialist jobs are hiring across the US. Find yours.
Find Quality Control Specialist JobsQuality Control Specialist H-1B Visa: Frequently Asked Questions
Does a Quality Control Specialist role qualify as a specialty occupation for H-1B purposes?
It depends on how the employer defines the position. A QC Specialist role qualifies when the employer requires a bachelor's degree or higher in a specific field such as engineering, chemistry, or biology as a normal condition of entry. Roles where any bachelor's degree is acceptable, regardless of field, are harder to defend as specialty occupations. USCIS evaluates the job description and industry norms, so the offer letter and LCA need to reflect the degree requirement precisely.
Which industries hire QC Specialists and sponsor H-1B visas most often?
Pharmaceutical and biotechnology manufacturers, medical device companies, semiconductor fabricators, and aerospace suppliers are the most consistent H-1B sponsors for QC Specialist roles. These industries operate under FDA, ISO, or FAA quality frameworks that require degree-level expertise, which supports the specialty occupation argument. You can browse employers with active H-1B LCA filing history for QC roles on Migrate Mate.
What SOC code applies to Quality Control Specialists, and why does it matter for H-1B?
The DOL typically maps QC Specialist roles to SOC code 51-9061 (Inspectors, Testers, Sorters, Samplers, and Weighers) or 17-2112 (Industrial Engineers), depending on job duties. The SOC code your employer selects on the LCA determines the prevailing wage level USCIS and DOL use to evaluate your offer. You can verify prevailing wage rates for your specific code and location using the OFLC Wage Search before accepting an offer.
Can I use OPT or STEM OPT as a QC Specialist while waiting for H-1B cap selection?
Yes. If your QC role at a STEM-designated employer falls under an eligible CIP code, you can extend your OPT by 24 months after your initial 12-month OPT period. Your employer must be E-Verify enrolled to authorize the STEM OPT extension. The combined 36 months of OPT authorization can bridge you through one or two H-1B lottery cycles while you remain in status and continue building QC experience.
How does the H-1B prevailing wage requirement affect QC Specialist job offers?
The LCA your employer files must certify that your offered wage meets or exceeds the prevailing wage for your SOC code, job level, and work location. DOL sets four wage levels based on experience and complexity. A Level I wage applies to entry-level QC roles; a Level II or III wage applies to roles requiring independent judgment or supervisory responsibility. Accepting a wage below the certified LCA wage violates the terms of your H-1B status.
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