H-1B Visa Quality Assurance Specialist Jobs
Quality Assurance Specialist roles qualify for H-1B visa sponsorship when the position requires a bachelor's degree or higher in a directly related field such as engineering, computer science, or quality management. Employers must file a Labor Condition Application with the DOL and submit Form I-129 to USCIS before your start date.
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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 Quality Assurance Specialist Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Quality Assurance Specialist
Verify your degree field matches the role
QA Specialist roles require a degree in a directly related field, such as industrial engineering, computer science, or quality management. A general business degree alone may not satisfy USCIS's specialty occupation standard for this job title.
Check employer LCA filing history by role
Use Migrate Mate to filter employers by verified DOL Labor Condition Application filings for QA Specialist roles. This shows you which companies have a real track record of sponsoring this specific occupation, not just H-1B filings generally.
Target E-Verify enrolled employers early
If you're transitioning from OPT or STEM OPT, your employer must be enrolled in E-Verify. Confirm enrollment before accepting an offer, since unenrolled employers can't legally employ you during cap-gap or OPT periods.
Document your QA methodology credentials
Certifications like ASQ CQE, ISTQB, or Six Sigma are not required by USCIS but strengthen the specialty occupation argument in your I-129 petition. Assemble these before the lottery so your employer's attorney can build the strongest petition.
Understand how prevailing wage affects your offer
Your employer's LCA must certify wages at or above the DOL prevailing wage for your job title and work location. Run your role and zip code through OFLC Wage Search before finalizing an offer to confirm the salary is compliant.
Plan around the 60-day grace period when switching jobs
If you're changing QA roles between H-1B employers, USCIS allows a 60-day grace period after your previous position ends. Your new employer must file an H-1B transfer petition before that window closes or your status lapses.
H-1B Visa Quality Assurance Specialist: Frequently Asked Questions
Does a Quality Assurance Specialist role qualify as a specialty occupation for H-1B purposes?
A QA Specialist role qualifies as a specialty occupation when the position normally requires a bachelor's degree or higher in a specific field such as engineering, computer science, or quality management. If the job description accepts any degree field or frames the degree as preferred rather than required, USCIS may issue a Request for Evidence challenging specialty occupation status. Your employer's petition should document that the role is complex enough to demand that specialized degree.
Which employers are most likely to sponsor H-1B visas for QA Specialist roles?
Employers in software development, medical device manufacturing, aerospace, and semiconductor fabrication regularly sponsor H-1B visas for QA Specialists because those industries require documented compliance processes that demand specialized degree backgrounds. Migrate Mate lets you search specifically for employers with verified LCA filings for QA roles, so you can focus on companies with an actual sponsorship track record rather than guessing from job postings.
Can I transfer my H-1B to a new QA employer without restarting the cap process?
Yes. H-1B portability under AC21 lets you transfer to a new employer in a same or similar occupational classification without re-entering the lottery, as long as your new employer files a transfer petition while your current H-1B is valid. QA Specialist roles generally fall under the same SOC code cluster, but your new employer's attorney should confirm the occupational classification matches before filing to avoid a denial.
What happens to my H-1B status if my QA role is restructured or eliminated?
If your position is eliminated, your H-1B status ends with your employment, and USCIS allows a 60-day grace period to find a new sponsoring employer, change to another valid status, or depart the U.S. Your previous employer is also required to pay for your return transportation to your home country. Acting within the 60-day window is critical because any day beyond it makes you out of status.
Does remote work affect H-1B sponsorship for QA Specialist positions?
Yes. H-1B status is tied to specific worksite locations listed in your employer's LCA. If you work remotely from a location not covered by the original LCA, your employer must file an amended LCA and potentially an amended H-1B petition with USCIS before you begin working at that location. QA roles that shift between client sites or require travel should have a blanket LCA covering those locations, which your employer's immigration counsel should verify.