Quality Assurance Specialist Jobs in USA with Visa Sponsorship
Quality Assurance Specialists qualify for H-1B visa, E-3 visa, and TN visa sponsorship when the role requires a bachelor's degree in computer science, engineering, or related technical field. QA roles involving test automation, compliance frameworks, or specialized industry knowledge (healthcare, finance, aerospace) have stronger visa approval odds than general manual testing positions. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsTHE POSITION
Two Principal QA Specialist positions are available: one will focus on Compounding, Filling, and Inspection, and the other will support Packaging and Labelling.
Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing.
The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.
Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation.
Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine.
The Opportunity
We are looking for a highly impactful Principal QA Specialist with extensive experience, a robust risk-based operational focus, and a strong compliance mindset. This critical role is essential for guaranteeing the delivery of top-quality products, consistently meeting global regulatory requirements and Roche's stringent internal standards.
In this role you will be a member of the QA team providing quality oversight for manufacturing and supporting processes, specifically for Compounding, Filling, and Inspection. You will manage end-to-end quality for these areas, collaborating closely with diverse partners, including MSAT, Operations, Warehouse, Engineering, Quality, QC, and Global teams, to guarantee strict adherence to all quality standards.
This position is a unique opportunity to embed quality into the site's operational design, support a continuous improvement culture, and drive operational excellence in accordance with Good Manufacturing Practices, establishing Holly Springs as a center of excellence for aseptic drug product manufacturing.
What You’ll Do
- Quality by Design: Support the establishment and implementation of operational procedures for Compounding, Filling and Inspection or Assembly and Packaging, ensuring appropriate risk-based controls are in place to embed “Quality by Design” into operational processes.
- Quality Management: Approve procedures and drive continuous improvement by regularly assessing and refining processes and procedures to maximize efficiency and effectiveness.
- Digital Quality: Work closely with the MES and SAP teams to design recipes and Manufacturing Batch Records and ensure master data aligns with validated process parameters.
- Release by Exception: Design the logic for Release by Exception, defining which critical process parameters must be automatically verified to allow for accelerated batch disposition.
- Design & Commissioning Phase: Support equipment and process design reviews, FAT, SAT and commissioning activities to design fit for purpose, lean, operational processes in advance of PQ.
- Investigations: Support or lead complex investigations, determining root causes and ensuring the implementation of effective Corrective and Preventive Actions. Utilize advanced tools to move beyond "human error" and identify true systemic vulnerabilities. Approve Deviations and CAPAs.
- Technical Expert & Problem Solver: Act as a subject matter expert and provide guidance on matters related to Compounding, Filling and Inspection or Assembly and Packaging, monitoring data and trends and identifying areas for improvement.
- Inspection support: Support inspection readiness, participate during regulatory inspections and support review/approval of the dossier sections.
- Compliance and Product Release: Participate in equipment and process risk assessments, approve change controls and perform release of incoming goods and manufactured products.
- Manufacturing Process Oversight (Compounding, Filling and Inspection): Provide direct oversight of dispensing, compounding, filling, visual inspection and process support operations, including oversight of cleanroom processes and behaviors, sterilization cycles and validation activities.
- Manufacturing Process Oversight (Assembly and Packaging): Provide direct oversight of device assembly and packaging and process support operations, including labelling, serialization and validation activities.
- Digital Footprint: Serves as the Quality Assurance Owner and approver for supporting applications that enable the digital transformation of shop-floor processes, replacing traditional paper documentation.
Who You Are
- You possess a Bachelor’s degree in a scientific discipline (a graduate or higher-level degree strongly preferred).
- Minimum of 8–10 years in a GxP environment, with at least 4 years of sterile drug product manufacturing experience or Device assembly and packaging experience in either a manufacturing, QA Operations or MSAT role.
- You are a strategic and systems thinker with a compliance focus, anticipating technology trends and driving excellence in execution, delivering operationally implementable solutions.
- Advanced GMP and quality regulation knowledge with experience participating in global regulatory inspections (FDA, EMA).
- You have expertise in Quality Assurance, demonstrated by your successful oversight of critical quality systems, including deviation management, CAPA, and product release processes.
- You have experience leading complex investigations and have strong technical writing skills.
- You excel at embedding operational excellence in complex, large-scale manufacturing environments.
- You have experience implementing and driving a continuous improvement culture.
- Good understanding of Annex 1 and how to operationally comply with these regulatory requirements.
- Hands-on experience with SAP and MES. You should be able to explain how a "Business Process" translates into a "Digital Recipe."
- You are able to work in a dynamic and fast-paced environment while always ensuring the highest quality and safety standards.
The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina is $114,700 - $212,900. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Link to Benefits
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
JOB FACTS
Job Sub Category Quality
Schedule Full time
Job Type Regular
Posted Date Apr 13th 2026
Job ID 202604-108899
THE POSITION
Two Principal QA Specialist positions are available: one will focus on Compounding, Filling, and Inspection, and the other will support Packaging and Labelling.
Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing.
The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028.
Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation.
Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine.
The Opportunity
We are looking for a highly impactful Principal QA Specialist with extensive experience, a robust risk-based operational focus, and a strong compliance mindset. This critical role is essential for guaranteeing the delivery of top-quality products, consistently meeting global regulatory requirements and Roche's stringent internal standards.
In this role you will be a member of the QA team providing quality oversight for manufacturing and supporting processes, specifically for Compounding, Filling, and Inspection. You will manage end-to-end quality for these areas, collaborating closely with diverse partners, including MSAT, Operations, Warehouse, Engineering, Quality, QC, and Global teams, to guarantee strict adherence to all quality standards.
This position is a unique opportunity to embed quality into the site's operational design, support a continuous improvement culture, and drive operational excellence in accordance with Good Manufacturing Practices, establishing Holly Springs as a center of excellence for aseptic drug product manufacturing.
What You’ll Do
- Quality by Design: Support the establishment and implementation of operational procedures for Compounding, Filling and Inspection or Assembly and Packaging, ensuring appropriate risk-based controls are in place to embed “Quality by Design” into operational processes.
- Quality Management: Approve procedures and drive continuous improvement by regularly assessing and refining processes and procedures to maximize efficiency and effectiveness.
- Digital Quality: Work closely with the MES and SAP teams to design recipes and Manufacturing Batch Records and ensure master data aligns with validated process parameters.
- Release by Exception: Design the logic for Release by Exception, defining which critical process parameters must be automatically verified to allow for accelerated batch disposition.
- Design & Commissioning Phase: Support equipment and process design reviews, FAT, SAT and commissioning activities to design fit for purpose, lean, operational processes in advance of PQ.
- Investigations: Support or lead complex investigations, determining root causes and ensuring the implementation of effective Corrective and Preventive Actions. Utilize advanced tools to move beyond "human error" and identify true systemic vulnerabilities. Approve Deviations and CAPAs.
- Technical Expert & Problem Solver: Act as a subject matter expert and provide guidance on matters related to Compounding, Filling and Inspection or Assembly and Packaging, monitoring data and trends and identifying areas for improvement.
- Inspection support: Support inspection readiness, participate during regulatory inspections and support review/approval of the dossier sections.
- Compliance and Product Release: Participate in equipment and process risk assessments, approve change controls and perform release of incoming goods and manufactured products.
- Manufacturing Process Oversight (Compounding, Filling and Inspection): Provide direct oversight of dispensing, compounding, filling, visual inspection and process support operations, including oversight of cleanroom processes and behaviors, sterilization cycles and validation activities.
- Manufacturing Process Oversight (Assembly and Packaging): Provide direct oversight of device assembly and packaging and process support operations, including labelling, serialization and validation activities.
- Digital Footprint: Serves as the Quality Assurance Owner and approver for supporting applications that enable the digital transformation of shop-floor processes, replacing traditional paper documentation.
Who You Are
- You possess a Bachelor’s degree in a scientific discipline (a graduate or higher-level degree strongly preferred).
- Minimum of 8–10 years in a GxP environment, with at least 4 years of sterile drug product manufacturing experience or Device assembly and packaging experience in either a manufacturing, QA Operations or MSAT role.
- You are a strategic and systems thinker with a compliance focus, anticipating technology trends and driving excellence in execution, delivering operationally implementable solutions.
- Advanced GMP and quality regulation knowledge with experience participating in global regulatory inspections (FDA, EMA).
- You have expertise in Quality Assurance, demonstrated by your successful oversight of critical quality systems, including deviation management, CAPA, and product release processes.
- You have experience leading complex investigations and have strong technical writing skills.
- You excel at embedding operational excellence in complex, large-scale manufacturing environments.
- You have experience implementing and driving a continuous improvement culture.
- Good understanding of Annex 1 and how to operationally comply with these regulatory requirements.
- Hands-on experience with SAP and MES. You should be able to explain how a "Business Process" translates into a "Digital Recipe."
- You are able to work in a dynamic and fast-paced environment while always ensuring the highest quality and safety standards.
The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina is $114,700 - $212,900. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Link to Benefits
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
JOB FACTS
Job Sub Category Quality
Schedule Full time
Job Type Regular
Posted Date Apr 13th 2026
Job ID 202604-108899
See all 477+ Quality Assurance Specialist jobs
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Get Access To All JobsTips for Finding Visa Sponsorship as a Quality Assurance Specialist
Emphasize Technical Complexity
Highlight automated testing frameworks, API testing, performance testing tools, and programming languages. Manual-only QA roles face higher scrutiny for specialty occupation requirements under visa regulations.
Target Industry-Specific QA Roles
Healthcare, financial services, and aerospace QA positions requiring regulatory compliance knowledge (FDA, SOX, FAA) demonstrate clear specialty occupation qualifications for visa sponsorship applications.
Focus on Enterprise Software Companies
Large software companies with complex products regularly sponsor QA specialists. They understand the technical expertise required and have established visa sponsorship processes and legal resources.
Highlight Security Testing Experience
Cybersecurity testing, penetration testing, and vulnerability assessment skills strengthen visa applications. These specialized areas require advanced technical knowledge beyond basic functional testing capabilities.
Document Degree-Role Connection
Prepare examples showing how your computer science, engineering, or IT degree directly applies to QA methodologies, testing frameworks, and technical problem-solving in your target role.
Consider QA Lead or Senior Positions
Leadership roles involving team management, process design, or tool selection demonstrate higher-level responsibilities that support specialty occupation arguments in visa petition filings.
Quality Assurance Specialist jobs are hiring across the US. Find yours.
Find Quality Assurance Specialist JobsFrequently Asked Questions
What degree do I need for QA visa sponsorship?
A bachelor's degree in computer science, software engineering, information technology, or a related technical field is typically required. Some employers accept degrees in mathematics, physics, or engineering if combined with relevant QA experience. The degree must directly relate to the technical aspects of quality assurance work.
Do manual testing roles qualify for H-1B sponsorship?
Manual-only QA roles face higher scrutiny and lower approval rates. USCIS expects specialty occupation roles to require technical expertise beyond basic clicking and following test scripts. Focus on positions involving test automation, API testing, performance testing, or industry-specific compliance knowledge to strengthen your case.
Which QA specializations have the best sponsorship prospects?
Test automation engineers, security testers, performance testing specialists, and QA roles in regulated industries (healthcare, finance, aerospace) have stronger sponsorship prospects. These positions require specialized technical knowledge and tools that clearly demonstrate specialty occupation requirements for visa approval.
Can I get sponsored as a QA contractor or consultant?
Yes, but the sponsoring company must be your actual employer, not the end client. Consulting firms that specialize in QA services often sponsor visas for permanent employees they place at client sites. Direct contractor relationships typically don't qualify for traditional employment-based visa sponsorship.
How to find Quality Assurance Specialist jobs with visa sponsorship?
To find Quality Assurance Specialist jobs with visa sponsorship, use Migrate Mate, which specializes in connecting international candidates with sponsoring employers. Focus your search on tech companies, software development firms, and large corporations that frequently sponsor H-1B, TN, and other work visas for QA professionals. These employers value QA specialists' technical skills in testing methodologies, automation tools, and quality processes.
What if my degree isn't in computer science?
You can still qualify through the three-for-one rule where three years of relevant work experience substitutes for one year of education. A two-year degree plus six years of progressive QA experience, or twelve years of experience without a degree, may meet the requirements depending on the role's complexity.
What is the prevailing wage requirement for sponsored Quality Assurance Specialist jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.
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