H-1B Visa QA Specialist Jobs
QA Specialist roles qualify for H-1B visa sponsorship when the position requires a bachelor's degree or higher in computer science, engineering, or a related technical field. Employers file a Labor Condition Application with DOL before petitioning USCIS, certifying the role meets specialty occupation standards and prevailing wage requirements.
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Get Access To All JobsINTRODUCTION
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic individual to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities
- Perform on-the-floor Plant Quality Assurance (PQA) review and approval of cGMP manufacturing processes, procedures, testing methods, documents, and production records.
- Review and approve batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise documentation, including deviations, CAPAs, and validations.
- Ensure deviations and quality events are properly triaged, investigated, documented, and resolved in accordance with procedures and cGMP requirements.
- Review and assess changes for potential impact to product quality and compliance.
- Support and oversee CAPA, change control, validation, and other Quality System activities.
- Partner cross-functionally with Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Facilities, Environmental, and Contractors to ensure compliance with established procedures.
- Provide Quality support for New Product Introduction (NPI) and complex projects.
- Support internal and external audits and regulatory inspections, serving as a Quality representative when required.
- Support commissioning and qualification activities and GxP application validation, including risk assessments and IQ/OQ/PQ documentation.
- Analyze quality data and trends, evaluate compliance issues, and provide recommendations to address quality and operational risks.
- Participate in and lead continuous improvement initiatives and quality projects.
- Communicate quality, compliance, supply, and safety risks to appropriate levels of management.
- Work independently while effectively leading, influencing, and collaborating with cross-functional teams.
BASIC QUALIFICATIONS
- Bachelor's degree in Science or Engineering
- Experience in Quality Assurance within a pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environment.
- Strong working knowledge of cGMP, Quality Systems, deviations, CAPA, change control, and validation.
- Experience with batch record review and manufacturing documentation.
- Experience supporting NPI, audits/inspections, commissioning, qualification, or GxP validation.
- Knowledge of computer systems validation / computer systems quality assurance is highly desirable.
- Strong analytical, problem-solving, organizational, and project management skills.
- Ability to lead cross-functional teams and effectively influence and negotiate with stakeholders.
- Strong English and Spanish written and verbal communication skills.
- Proficiency with word processing, presentation, database, and spreadsheet applications.
- Ability to evaluate compliance issues and interpret quality data/trends.
- Ability to work independently and interact effectively with employees and leadership at all organizational levels.
- Non-Standard Shift
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
INTRODUCTION
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic individual to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities
- Perform on-the-floor Plant Quality Assurance (PQA) review and approval of cGMP manufacturing processes, procedures, testing methods, documents, and production records.
- Review and approve batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise documentation, including deviations, CAPAs, and validations.
- Ensure deviations and quality events are properly triaged, investigated, documented, and resolved in accordance with procedures and cGMP requirements.
- Review and assess changes for potential impact to product quality and compliance.
- Support and oversee CAPA, change control, validation, and other Quality System activities.
- Partner cross-functionally with Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Facilities, Environmental, and Contractors to ensure compliance with established procedures.
- Provide Quality support for New Product Introduction (NPI) and complex projects.
- Support internal and external audits and regulatory inspections, serving as a Quality representative when required.
- Support commissioning and qualification activities and GxP application validation, including risk assessments and IQ/OQ/PQ documentation.
- Analyze quality data and trends, evaluate compliance issues, and provide recommendations to address quality and operational risks.
- Participate in and lead continuous improvement initiatives and quality projects.
- Communicate quality, compliance, supply, and safety risks to appropriate levels of management.
- Work independently while effectively leading, influencing, and collaborating with cross-functional teams.
BASIC QUALIFICATIONS
- Bachelor's degree in Science or Engineering
- Experience in Quality Assurance within a pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environment.
- Strong working knowledge of cGMP, Quality Systems, deviations, CAPA, change control, and validation.
- Experience with batch record review and manufacturing documentation.
- Experience supporting NPI, audits/inspections, commissioning, qualification, or GxP validation.
- Knowledge of computer systems validation / computer systems quality assurance is highly desirable.
- Strong analytical, problem-solving, organizational, and project management skills.
- Ability to lead cross-functional teams and effectively influence and negotiate with stakeholders.
- Strong English and Spanish written and verbal communication skills.
- Proficiency with word processing, presentation, database, and spreadsheet applications.
- Ability to evaluate compliance issues and interpret quality data/trends.
- Ability to work independently and interact effectively with employees and leadership at all organizational levels.
- Non-Standard Shift
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
See all 1,088+ H-1B Visa QA Specialist Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a QA Specialist
Align your degree to the role
USCIS requires your degree field to directly relate to QA work. A computer science or engineering degree is a clean fit. If your degree is in a different field, document how your coursework maps to software testing, quality systems, or validation methodologies.
Search LCA filings for QA sponsors
Use OFLC Wage Search to filter Labor Condition Application filings by SOC code 15-1253 or job title. Companies with consistent QA LCA filings have an established sponsorship process and are less likely to withdraw an offer mid-petition.
Find verified sponsors on Migrate Mate
Use Migrate Mate to browse QA Specialist roles filtered by employers with active H-1B filing history. It surfaces DOL LCA data so you can see which companies have sponsored QA positions before, not just which ones say they're open to sponsorship.
Confirm specialty occupation before accepting
Before signing an offer, ask the employer how they documented the QA role as a specialty occupation in prior petitions. Roles framed as general testers without a required degree field draw higher RFE rates than those tied to specific engineering or systems domains.
Time your job search around the cap
H-1B cap petitions are filed in April for an October 1 start. If you're on OPT, count backward from your EAD expiration to confirm you have enough runway. Cap-exempt employers such as universities and nonprofit research institutions can file year-round.
Check E-Verify enrollment for STEM OPT
If you're extending OPT and bridging to H-1B, your employer must be enrolled in E-Verify for STEM OPT approval. Verify enrollment status directly with your employer's HR team before your 90-day application window opens.
H-1B Visa QA Specialist: Frequently Asked Questions
Does a QA Specialist role qualify as a specialty occupation for H-1B purposes?
Yes, if the employer defines the position as requiring at least a bachelor's degree in a specific technical field such as computer science, software engineering, or information systems. Generically titled roles where any degree is accepted can face RFEs. The stronger the connection between the degree requirement and the job duties, the cleaner the specialty occupation argument.
How do I find employers who have sponsored H-1B visas for QA Specialist roles before?
Migrate Mate shows verified H-1B filing history by employer and role, so you can identify companies that have sponsored QA positions rather than relying on employer self-reporting. DOL LCA disclosure data is publicly available and updated regularly, which is what powers these results. Focus on companies with multiple QA filings across different years.
What SOC code does USCIS and DOL use for QA Specialist positions?
Most QA Specialist roles file under SOC code 15-1253, Software Quality Assurance Analysts and Testers, though some employers use 15-1252 or broader software developer codes depending on how the role is structured. The SOC code determines the prevailing wage tier your employer must certify on the LCA. You can look up the occupation details and wage levels using O*NET and OFLC Wage Search.
Can I switch employers after my H-1B is approved for a QA Specialist role?
Yes, H-1B portability under AC21 allows you to change employers after your petition has been pending for 180 days or more, as long as the new role is in the same or a similar occupational classification. Your new employer files an H-1B transfer petition, and you can start working for them as soon as USCIS receives it. USCIS guidance covers the specific same-classification requirements.
Does my employer need to prove they tried to hire U.S. workers before sponsoring my H-1B?
No, H-1B sponsorship does not require a PERM labor market test. PERM applies to employment-based green cards, not H-1B petitions. Your employer files a Labor Condition Application with DOL certifying prevailing wage compliance, but there is no recruitment attestation required. This is a key distinction that makes H-1B sponsorship faster than permanent residence sponsorship.