OPT Quality Assurance Specialist Jobs
Quality Assurance Specialist roles are a strong fit for F-1 OPT students in STEM fields like computer science, engineering, and information systems. Most QA positions qualify for the 24-month STEM OPT extension, giving you up to three years of U.S. work authorization to build a career in software testing, quality engineering, or process improvement.
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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 Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Quality Assurance Specialist Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Quality Assurance Specialist
Lead with your STEM OPT eligibility
Mention your STEM OPT authorization upfront in your resume summary and cover letter. Employers in tech and manufacturing are familiar with the 24-month extension, and framing it as three years of runway removes a common objection before the conversation starts.
Target industries with high QA demand
Software, medical devices, automotive, and aerospace companies hire QA Specialists at volume. These industries have established immigration compliance programs and are more likely to support OPT students through the authorization period and into H-1B visa sponsorship down the line.
Get specific about your testing toolkit
Employers screen QA candidates on tools first. Highlight experience with Selenium, JIRA, TestRail, Postman, or SQL on your resume. Specificity signals job readiness and shortens the evaluation process, which matters when hiring managers are weighing OPT timelines.
Frame quality metrics as business impact
QA work is easy to undersell. Quantify your contributions: defect rates reduced, test coverage increased, release cycles shortened. Employers evaluating OPT candidates want evidence that you add measurable value, not just that you can follow a testing protocol.
Address your OPT end date honestly and early
If an employer asks about your work authorization timeline, be straightforward. Explain your current OPT period, your STEM extension eligibility if applicable, and that you're actively building toward long-term sponsorship. Clarity early prevents misaligned expectations later in the process.
Prioritize companies with active I-129 filing histories
Companies that have sponsored H-1B petitions in QA or engineering roles are more likely to do it again. Researching employer sponsorship history before applying lets you focus your effort on realistic opportunities rather than roles that have never supported visa sponsorship.
Quality Assurance Specialist OPT: Frequently Asked Questions
Do Quality Assurance Specialist jobs qualify for the STEM OPT extension?
Most Quality Assurance Specialist positions qualify for the 24-month STEM OPT extension, provided your degree is in an eligible field such as computer science, information systems, engineering, or a related STEM discipline. The role itself must also be directly related to your degree. If both conditions are met, you can work for up to three years total on OPT before needing H-1B or another status.
What do employers need to know about hiring a QA Specialist on OPT?
Employers don't need to file any visa petition to hire you on OPT. Your work authorization comes from your EAD card, which you manage through your university's DSO. The employer's main obligations are to confirm the role relates to your degree field and, if you're on STEM OPT, to register with E-Verify and provide a formal training plan. Most mid-size and large companies already meet these requirements.
Can I work as a QA Specialist contractor or on a contract-to-hire basis on OPT?
Yes, contract and contract-to-hire arrangements are generally permitted on OPT, provided you have a clear employer-employee relationship and the work relates to your degree. Staffing agency placements can work, but you must have a bona fide offer and cannot be self-employed. Confirm the arrangement with your DSO before accepting, since STEM OPT has additional reporting requirements that affect how contract work is documented.
Where can I find Quality Assurance Specialist jobs that are open to OPT candidates?
Migrate Mate is built specifically for F-1 OPT and visa-sponsored job searches. You can filter for Quality Assurance Specialist roles by job title, industry, and visa sponsorship status, so you're only seeing employers who are open to your work authorization situation. General job boards don't filter this way, which means a lot of wasted applications on roles that won't move forward with OPT candidates.
What happens to my QA job if my OPT expires before my H-1B is approved?
If your employer files an H-1B petition before your OPT expires and you're subject to the cap, you may be protected by cap-gap, which automatically extends your OPT status through September 30 of that year. During cap-gap, you can continue working for the same employer in the same role. If you're not selected in the lottery or your employer doesn't file in time, your authorization ends when your OPT expires and you'd need to stop working.