OPT Quality Assurance Analyst Jobs
Quality Assurance Analyst roles are a strong fit for F-1 OPT students with degrees in computer science, information systems, or engineering. Most positions qualify as STEM-designated, giving you up to 36 months of work authorization. Employers in software, finance, and healthcare regularly hire QA talent at the entry level.
Find OPT Quality Assurance Analyst JobsOverview
Showing 5 of 463+ Quality Assurance Analyst jobs
See all 463+ Quality Assurance Analyst Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Quality Assurance Analyst roles.
Get Access To All JobsBuild 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
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 Analyst Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Quality Assurance Analyst Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Quality Assurance Analyst
Target STEM-designated employers first
QA Analyst roles at software and tech companies almost always qualify for STEM OPT extension. Prioritize employers enrolled in E-Verify, since that's a requirement for the 24-month STEM extension that takes your total OPT to 36 months.
Highlight your degree field clearly
STEM OPT eligibility depends on your degree, not just the job title. Make sure your resume explicitly names your major. If it's computer science, information systems, or engineering, spell that out so hiring managers can quickly confirm your extension eligibility.
Lead with automation skills over manual testing
Employers sponsoring OPT students want high technical value. Proficiency in Selenium, Cypress, or Playwright signals specialization that justifies the paperwork. Manual-only QA profiles are harder to sponsor because the role looks more replaceable to hiring managers reviewing OPT candidates.
Understand your OPT end date before applying
Know exactly how much OPT time you have left before starting applications. If you have under six months remaining, prioritize employers with fast hiring cycles or who have sponsored STEM OPT before. Timing mismatches are a common reason OPT hires fall through late in the process.
Frame QA as a technical engineering function
Some employers misclassify QA as a non-technical support role. In your cover letter and interviews, position the work as software quality engineering. This framing helps HR teams understand why it qualifies under your STEM degree and supports the case for STEM OPT extension.
Ask about DSO reporting requirements upfront
On STEM OPT, your employer must evaluate your training every 12 months using Form I-983. Raise this early so the hiring manager and HR team know what's involved. Employers who have sponsored STEM OPT before will recognize the requirement and won't be caught off guard.
Quality Assurance Analyst OPT: Frequently Asked Questions
Do Quality Assurance Analyst jobs qualify for the STEM OPT extension?
Most do, but it depends on your degree. If you graduated with a STEM-designated degree in computer science, information systems, software engineering, or a related field, and the QA role involves software testing or quality engineering, you'll generally qualify for the 24-month STEM OPT extension on top of your initial 12 months. Confirm with your DSO before accepting an offer.
How do I find Quality Assurance Analyst jobs that accept OPT students?
Migrate Mate lists QA Analyst roles from employers who have a track record of hiring international students on OPT. Filtering by OPT-friendly employers saves significant time compared to applying broadly and discovering late in the process that a company won't work with OPT candidates. Search Migrate Mate specifically for QA and software testing roles.
What does a QA Analyst employer need to do to support my STEM OPT?
For the STEM OPT extension, your employer must be enrolled in E-Verify, sign your Form I-983 training plan, and conduct formal evaluations at the 12-month and final marks of the extension period. The I-983 outlines your learning goals and how the role relates to your degree. Most established tech and software employers are already familiar with this process.
Can I work as a QA Analyst contractor on OPT?
Yes, OPT permits contract and staffing agency arrangements, but there are constraints. You must have a formal work relationship with a real employer, not operate as a fully independent contractor. For STEM OPT specifically, the employer signing your I-983 must be the company where you're actually working, not just the staffing agency placing you.
What happens if my OPT expires before I find a QA Analyst job?
If your initial OPT expires without employment, your F-1 status ends and you enter a 60-day grace period. During that window, you can apply to change status, leave the U.S., or transfer to a new school. The STEM OPT extension must be filed while your initial OPT is still valid and you're employed in a qualifying role, so timing matters significantly.