OPT Quality Assurance Lead Jobs
Quality Assurance Lead roles are well-suited for F-1 OPT students with degrees in computer science, software engineering, or information systems. Most positions fall under STEM OPT extension-eligible SOC codes, giving you up to 36 months of work authorization. Strong QA backgrounds in test automation and team coordination translate directly into roles that actively sponsor visas.
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At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill a QA Microbiology Specialist position within our Advanced Therapies Quality Assurance team. This position provides technical expertise and quality oversight for microbiology, contamination control, and microbial quality programs supporting Advanced Therapies operations. This role supports developing and overseeing microbiological control strategies, supports regulatory and compliance activities, supports driving platform-level microbial testing approaches, and serves as a key quality partner for process development, technology transfer, and external manufacturing operations.
When & Where
Location: East Greenbush, New York, United States
Work schedule: Monday-Friday, 8am-4:30pm
Discover Your Role
Microbiology & Contamination Control Support
Provide technical support and oversight for microbiological quality systems and contamination control programs, including:
- Support the development, implementation, and maintenance of contamination control strategies aligned with regulatory requirements and industry best practices.
- Review and assess environmental monitoring programs and associated data trends.
- Provide oversight and technical assessment of bioburden, endotoxin, and other microbiological testing activities.
- Conduct microbiological risk assessments and support implementation of mitigation actions.
- Technical support for regulatory submissions, inspections, and responses to Regulatory Information Requests.
Microbiology Program Development & Continuous Improvement
Contribute to the advancement of microbiology programs and initiatives by:
- Supporting the development and standardization of microbiological practices across Advanced Therapies programs.
- Participating in cross-functional discussions to align microbiological requirements and contamination control expectations.
- Identifying opportunities for process improvements and enhancements to microbial quality programs.
- Monitoring industry and regulatory trends to recommend enhancements to microbiological programs.
Technology Transfer, Sampling Plans & Process Support
Provide microbiology expertise to support manufacturing and product lifecycle activities, including:
- Review and approve microbiology-related sampling plans.
- Review Process Transmittal Requirement documents and technical transfer documentation.
- Support development and optimization of in-process, raw material, buffer, and product testing strategies.
- Partner with Manufacturing, Process Development, and Quality teams during technology transfer activities.
- Evaluate microbiological considerations associated with process changes and new product introductions.
Quality Event Review & Investigation Support
Support Microbiology-related Quality Systems And Issue Resolution Activities, Including:
- Review batch, release, and in-process testing deviations for microbiological impact.
- Assess microbiology-related deviations, nonconformances, and quality events.
- Participate in investigations, root cause analyses, and development of corrective and preventive actions (CAPAs).
- Support Quality Council discussions and other quality governance activities as needed.
- Assess microbiological impact of supplier changes, material changes, and manufacturing modifications.
- Provide technical recommendations to support product disposition and quality decisions.
Cross-Functional Partnership & Technical Expertise
- Serve as a microbiology subject matter expert within Quality and Manufacturing organizations.
- Provide technical guidance on microbiological testing, contamination control, and microbial risk management.
- Collaborate with internal and external stakeholders to support microbiological compliance and quality objectives.
- Share knowledge and mentor colleagues on microbiology-related processes and best practices.
- Promote a culture of quality, compliance, and continuous improvement.
This Role Requires
- Bachelor’s degree in Microbiology, Biological Sciences, Biotechnology, Pharmacy, or a related scientific discipline, or equivalent combination of education and experience, and the following amount of relevant work experience for each level:
+ Associate Specialist – 0-2 years
+ Specialist – 2+ years
+ Senior Specialist – 5+ years
+ Level will be determined based on experience
- Experience in pharmaceutical, biotechnology, cell and gene therapy, or advanced therapies manufacturing environments.
- Strong knowledge of Environmental monitoring programs, Contamination control strategies, Bioburden and endotoxin testing, Aseptic processing principles, Microbiological quality systems.
- Experience supporting investigations, deviations, CAPAs, and risk assessments.
- Familiarity with regulatory expectations and inspection readiness activities.
- Strong technical writing, communication, and cross-functional collaboration skills.
- Ability to independently assess microbiological risks and provide scientifically sound recommendations.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way!
We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.
Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.
For additional information about Regeneron benefits in the U.S., please visit the careers page. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
Salary Range (annually)
$62,355.00 - $128,700.00
Build Our Future Together
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill a QA Microbiology Specialist position within our Advanced Therapies Quality Assurance team. This position provides technical expertise and quality oversight for microbiology, contamination control, and microbial quality programs supporting Advanced Therapies operations. This role supports developing and overseeing microbiological control strategies, supports regulatory and compliance activities, supports driving platform-level microbial testing approaches, and serves as a key quality partner for process development, technology transfer, and external manufacturing operations.
When & Where
Location: East Greenbush, New York, United States
Work schedule: Monday-Friday, 8am-4:30pm
Discover Your Role
Microbiology & Contamination Control Support
Provide technical support and oversight for microbiological quality systems and contamination control programs, including:
- Support the development, implementation, and maintenance of contamination control strategies aligned with regulatory requirements and industry best practices.
- Review and assess environmental monitoring programs and associated data trends.
- Provide oversight and technical assessment of bioburden, endotoxin, and other microbiological testing activities.
- Conduct microbiological risk assessments and support implementation of mitigation actions.
- Technical support for regulatory submissions, inspections, and responses to Regulatory Information Requests.
Microbiology Program Development & Continuous Improvement
Contribute to the advancement of microbiology programs and initiatives by:
- Supporting the development and standardization of microbiological practices across Advanced Therapies programs.
- Participating in cross-functional discussions to align microbiological requirements and contamination control expectations.
- Identifying opportunities for process improvements and enhancements to microbial quality programs.
- Monitoring industry and regulatory trends to recommend enhancements to microbiological programs.
Technology Transfer, Sampling Plans & Process Support
Provide microbiology expertise to support manufacturing and product lifecycle activities, including:
- Review and approve microbiology-related sampling plans.
- Review Process Transmittal Requirement documents and technical transfer documentation.
- Support development and optimization of in-process, raw material, buffer, and product testing strategies.
- Partner with Manufacturing, Process Development, and Quality teams during technology transfer activities.
- Evaluate microbiological considerations associated with process changes and new product introductions.
Quality Event Review & Investigation Support
Support Microbiology-related Quality Systems And Issue Resolution Activities, Including:
- Review batch, release, and in-process testing deviations for microbiological impact.
- Assess microbiology-related deviations, nonconformances, and quality events.
- Participate in investigations, root cause analyses, and development of corrective and preventive actions (CAPAs).
- Support Quality Council discussions and other quality governance activities as needed.
- Assess microbiological impact of supplier changes, material changes, and manufacturing modifications.
- Provide technical recommendations to support product disposition and quality decisions.
Cross-Functional Partnership & Technical Expertise
- Serve as a microbiology subject matter expert within Quality and Manufacturing organizations.
- Provide technical guidance on microbiological testing, contamination control, and microbial risk management.
- Collaborate with internal and external stakeholders to support microbiological compliance and quality objectives.
- Share knowledge and mentor colleagues on microbiology-related processes and best practices.
- Promote a culture of quality, compliance, and continuous improvement.
This Role Requires
- Bachelor’s degree in Microbiology, Biological Sciences, Biotechnology, Pharmacy, or a related scientific discipline, or equivalent combination of education and experience, and the following amount of relevant work experience for each level:
+ Associate Specialist – 0-2 years
+ Specialist – 2+ years
+ Senior Specialist – 5+ years
+ Level will be determined based on experience
- Experience in pharmaceutical, biotechnology, cell and gene therapy, or advanced therapies manufacturing environments.
- Strong knowledge of Environmental monitoring programs, Contamination control strategies, Bioburden and endotoxin testing, Aseptic processing principles, Microbiological quality systems.
- Experience supporting investigations, deviations, CAPAs, and risk assessments.
- Familiarity with regulatory expectations and inspection readiness activities.
- Strong technical writing, communication, and cross-functional collaboration skills.
- Ability to independently assess microbiological risks and provide scientifically sound recommendations.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way!
We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.
Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.
For additional information about Regeneron benefits in the U.S., please visit the careers page. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
Salary Range (annually)
$62,355.00 - $128,700.00
See all 463+ OPT Quality Assurance Lead Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Quality Assurance Lead Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship in Quality Assurance Lead
Target companies with established QA teams
Large software, fintech, and healthcare technology companies run dedicated QA organizations and have existing H-1B visa sponsorship pipelines. These employers understand the visa process and are far more likely to sponsor than startups hiring their first QA engineer.
Emphasize your automation skills front and center
QA Lead roles requiring Selenium, Cypress, or Playwright are consistently harder to fill than manual testing roles. Employers sponsoring visas want proven ROI. Automation expertise signals that you're solving a skill gap, which makes sponsorship a much easier internal conversation.
Frame leadership experience in your resume clearly
QA Lead implies people management or at minimum cross-functional coordination. Spell out team size, reporting structure, and the scope of your test strategy ownership. Vague leadership claims reduce your competitiveness against candidates with clearly documented lead experience.
Apply during your OPT window, not after
Start your search at least three months before your initial OPT expires. Employers who are willing to sponsor need time to file the H-1B or consider E-3 visa or TN visa options. Waiting until the final weeks dramatically limits which employers can realistically move forward.
Prioritize STEM-eligible roles to maximize your timeline
Confirm the job posting's SOC code aligns with STEM OPT extension eligibility before applying. QA Lead roles under software quality assurance engineering SOC codes typically qualify. The 24-month extension gives employers a longer runway to complete H-1B sponsorship.
Address sponsorship directly and early in conversations
Bring up your OPT status and visa needs in the first recruiter screen, not after an offer. Employers who cannot sponsor will tell you immediately, saving both sides weeks of time. Employers who can sponsor appreciate the transparency and will plan accordingly.
Quality Assurance Lead OPT: Frequently Asked Questions
Do Quality Assurance Lead roles typically qualify for the STEM OPT extension?
Most QA Lead roles qualify for the 24-month STEM OPT extension when the position falls under a STEM-designated SOC code, such as software quality assurance engineers and testers. Your degree field also matters. Degrees in computer science, information systems, or software engineering generally satisfy the STEM OPT extension requirements. Confirm the SOC code with your employer's HR team before applying for the extension.
How common is H-1B sponsorship for Quality Assurance Lead positions?
Sponsorship rates are meaningfully higher for QA Lead roles than for entry-level QA positions because the lead-level skill set, particularly test automation and team oversight, is harder to source domestically. Mid-size and enterprise software companies, especially in fintech, healthtech, and SaaS, are the most consistent sponsors. Migrate Mate lists QA Lead openings filtered by sponsorship availability so you can focus your applications on employers already open to sponsoring.
Can I work as a Quality Assurance Lead on OPT if my degree is in a non-engineering field?
It depends on whether your degree has a direct connection to the role. OPT authorizes work directly related to your major area of study. A degree in information technology, computer science, or a related technical field has a clear connection to QA Lead work. A degree in business or communications would require a stronger case. Your DSO can help you assess whether the role qualifies under your specific degree program.
What visa options are available after OPT expires for a Quality Assurance Lead?
The H-1B is the most common path. QA Lead roles meet the specialty occupation standard because they require a bachelor's degree or higher in a specific technical field. If you're an Australian citizen, the E-3 visa is a faster and lottery-free alternative. Canadian and Mexican nationals may qualify under TN status. Your employer initiates all of these petitions, so identifying a sponsoring employer during your OPT window is the critical first step.
How should I handle the gap between OPT expiration and H-1B approval as a QA Lead?
If your employer files an H-1B cap-subject petition before your OPT expires and you have a valid STEM OPT extension in place, the cap-gap rule allows you to continue working through September 30 of that year. This requires your STEM OPT extension to be timely filed and your employer to submit the H-1B petition before the April 1 filing window opens. Work closely with your employer's immigration attorney to ensure no authorization gap occurs.