OPT Software Quality Assurance Jobs
Software Quality Assurance jobs are a strong fit for F-1 OPT students, with STEM OPT extension eligibility common across QA roles in tech and software companies. Your 12-month OPT window, extendable to 36 months, gives employers enough runway to justify H-1B visa sponsorship for qualified engineers.
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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 Software Quality Assurance Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Software Quality Assurance Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship in Software Quality Assurance
Target companies with active H-1B filing history
Companies that have sponsored H-1B visas for QA engineers in the past are far more likely to do it again. Search OFLC disclosure data to verify which employers have filed LCAs for Software Quality Assurance or QA Engineer job titles.
Emphasize automation skills over manual testing
Employers are significantly more likely to sponsor OPT students who can write test automation frameworks in Python, Java, or JavaScript. Automation-focused QA roles are harder to fill and easier to justify as specialty occupations for H-1B purposes.
Get your STEM OPT extension filed early
Apply for your 24-month STEM OPT extension at least 90 days before your initial OPT expires. Your employer must be enrolled in E-Verify. Delays in filing can create work authorization gaps that disqualify you mid-employment.
Frame your degree as a specialty occupation match
QA engineering roles require a qualifying degree in computer science, information systems, or a related technical field to meet H-1B specialty occupation standards. Ensure your resume connects your degree to your QA responsibilities directly and explicitly.
Pursue certifications that signal long-term value
Certifications like ISTQB, AWS Certified Developer, or Selenium training demonstrate commitment to the field and make sponsorship conversations easier. Employers weigh long-term investment potential heavily when deciding whether to initiate an H-1B petition.
Negotiate your start date around OPT activation
OPT only activates on the date listed on your EAD card. Communicate your authorized start date clearly during offer negotiations. Most tech employers with OPT experience will accommodate a two-to-four week buffer without rescinding an offer.
Software Quality Assurance OPT: Frequently Asked Questions
Do Software Quality Assurance jobs qualify for the STEM OPT extension?
Yes, most Software Quality Assurance roles qualify for the 24-month STEM OPT extension because they typically fall under CIP codes related to computer science or information technology. Your degree must be in a STEM-designated field and your employer must be enrolled in E-Verify. Confirm your specific CIP code with your DSO before applying.
How do I find Software Quality Assurance jobs that sponsor OPT and H-1B visas?
Migrate Mate lists Software Quality Assurance jobs from employers who are open to sponsoring OPT and H-1B visas, so you can filter out roles where authorization is a barrier from the start. Beyond that, cross-reference any employer on your list against OFLC public disclosure data to confirm they have actually filed LCAs for QA roles before.
Can I work as a QA contractor or on a third-party placement while on OPT?
Yes, but it requires care. OPT permits employment at a third-party worksite if the work is directly related to your degree. You must have a formal offer letter from the staffing agency or primary employer, not just a verbal arrangement. Self-employment or working without a clear employer-employee relationship can jeopardize your OPT status.
What happens to my OPT status if my QA job is eliminated or I'm laid off?
You have a cumulative 90-day unemployment allowance during your initial 12-month OPT period, and an additional 60 days during the STEM extension. Unemployment days count from the moment your employment ends. Report any job change or termination to your DSO immediately and document your job search activity in case your status is ever questioned.
Do remote Software Quality Assurance jobs count as valid OPT employment?
Yes, remote QA work is valid OPT employment as long as the company is a legitimate U.S. employer and the role is directly related to your degree field. Your employer address on record with your school should reflect where the company is based. Fully remote roles with U.S.-incorporated companies are generally treated the same as on-site positions for OPT compliance purposes.