OPT Quality Assurance Engineer Jobs
Quality Assurance Engineer roles are among the more OPT-friendly positions in tech, with STEM OPT extension eligibility giving you up to three years of work authorization. Employers hiring QA engineers regularly sponsor H-1B visas, making this a strong long-term path for F-1 students.
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Get Access To All JobsJob Title: Quality Assurance Specialist
- Location: Framingham, MA
About the Job
Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi's Framingham Biologics facilities. QA's main responsibility is to ensure cGMPs are adhered to during manufacturing operations. Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality and efficacy of Sanofi's Products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company's business and global markets.
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.
Main Responsibilities
The Quality Assurance Specialist is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP. The Quality Assurance Specialist is also responsible for mentoring and supporting the junior staff.
Core Responsibilities include:
- Provide Gemba Support
- Perform batch record review
- Perform review of column packing and qualification records
- Function as SME on input related to quality decisions
- Approve Non-conforming material discards
- Perform log book review
- Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps
- Issue action notices and conduct affiliated provisional release
- Conduct log book audits against compliance requirements
- Review Cleaning Verification (CV) related documentation against specification
- Perform media / buffer and intermediate release
- Prepare Bioreactor summary
- Support internal audit preparation activities as well as cross-functional internal audit activities and conduct walkthrough inspections
- Execute containment activities
- Provide off-hour support for batch record and log book issuance
- Partner with manufacturing and support operations to ensure a culture of continuous compliance
- May provide training to new employees
- Revise procedures / SOPs
- Initiate and Investigate and QA review deviations
- Review NRSR (Non-Routine Sample Requests)
- Other activities as assigned
- Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
Leadership Qualifications:
An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services. This includes:
- Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Sanofi a great place to work and a company respected for the quality of its people and products.
- Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.
About You
Basic Qualifications
- Bachelor’s Degree in a scientific field and 4 years of related experience, associate’s degree and 6 years of related experience or High School Diploma and 8 years of related experience in a Quality and/or other CGMP related field.
- Bachelor’s degree in a non-scientific field with 6 years of related experience in a Quality and/or cGMP environment.
- Basic to Intermediate computer proficiency, strong verbal and written communication skills.
- Experience with quality systems and cGMP data review
Preferred Qualifications:
- Bachelor’s degree in a scientific field with 4 years of experience in a Quality and/or cGMP environment.
- Experience in bio-pharmaceutical industry.
- Strong technical writing skills
- Effective time management, attention to detail, organizational skills, teamwork and collaborations.
- Demonstrated competence in problem solving methodology.
- Experience participating and/or leading cross-functional project team collaborations.
Special Working Conditions:
- Ability to gown and gain entry to manufacturing areas
- Ability to work a 10-hour shift with rotating weekend coverage, including some holidays
- Ability to lift 10 lbs
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Job Title: Quality Assurance Specialist
- Location: Framingham, MA
About the Job
Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi's Framingham Biologics facilities. QA's main responsibility is to ensure cGMPs are adhered to during manufacturing operations. Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality and efficacy of Sanofi's Products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company's business and global markets.
Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.
Main Responsibilities
The Quality Assurance Specialist is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP. The Quality Assurance Specialist is also responsible for mentoring and supporting the junior staff.
Core Responsibilities include:
- Provide Gemba Support
- Perform batch record review
- Perform review of column packing and qualification records
- Function as SME on input related to quality decisions
- Approve Non-conforming material discards
- Perform log book review
- Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps
- Issue action notices and conduct affiliated provisional release
- Conduct log book audits against compliance requirements
- Review Cleaning Verification (CV) related documentation against specification
- Perform media / buffer and intermediate release
- Prepare Bioreactor summary
- Support internal audit preparation activities as well as cross-functional internal audit activities and conduct walkthrough inspections
- Execute containment activities
- Provide off-hour support for batch record and log book issuance
- Partner with manufacturing and support operations to ensure a culture of continuous compliance
- May provide training to new employees
- Revise procedures / SOPs
- Initiate and Investigate and QA review deviations
- Review NRSR (Non-Routine Sample Requests)
- Other activities as assigned
- Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
Leadership Qualifications:
An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services. This includes:
- Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Sanofi a great place to work and a company respected for the quality of its people and products.
- Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.
About You
Basic Qualifications
- Bachelor’s Degree in a scientific field and 4 years of related experience, associate’s degree and 6 years of related experience or High School Diploma and 8 years of related experience in a Quality and/or other CGMP related field.
- Bachelor’s degree in a non-scientific field with 6 years of related experience in a Quality and/or cGMP environment.
- Basic to Intermediate computer proficiency, strong verbal and written communication skills.
- Experience with quality systems and cGMP data review
Preferred Qualifications:
- Bachelor’s degree in a scientific field with 4 years of experience in a Quality and/or cGMP environment.
- Experience in bio-pharmaceutical industry.
- Strong technical writing skills
- Effective time management, attention to detail, organizational skills, teamwork and collaborations.
- Demonstrated competence in problem solving methodology.
- Experience participating and/or leading cross-functional project team collaborations.
Special Working Conditions:
- Ability to gown and gain entry to manufacturing areas
- Ability to work a 10-hour shift with rotating weekend coverage, including some holidays
- Ability to lift 10 lbs
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
GD-SG
LI-GZ
vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
See all 413+ OPT Quality Assurance Engineer Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Quality Assurance Engineer Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Quality Assurance Engineer
Target companies with active QA engineering teams
Large software companies and SaaS businesses maintain dedicated QA teams and sponsor visas regularly. Focus your search on employers with established engineering organizations, where QA is a core function rather than an afterthought shared across roles.
Emphasize your STEM degree when applying
QA Engineer roles typically qualify for the 24-month STEM OPT extension if your degree is in computer science, software engineering, or a related field. Confirm your degree appears on the STEM designated degree program list before applying.
Highlight automation skills over manual testing
Employers sponsoring visas want to justify the cost. Automation-focused QA engineers who can write test scripts in Python, Java, or Selenium are harder to replace and make a stronger case for sponsorship than manual testers alone.
Ask about sponsorship before the final interview round
Bring up OPT and future H-1B sponsorship during the second or third interview stage, not the first. Framing it as planning ahead rather than an immediate demand gives hiring managers room to confirm their policy without feeling pressured.
Use your OPT period to build a testing portfolio
Document QA projects, test frameworks you've built, and bugs you've caught that prevented production incidents. Concrete outcomes tied to business impact strengthen your case for sponsorship by showing measurable value to the employer.
Search for OPT-friendly QA roles on Migrate Mate
Migrate Mate filters jobs by sponsorship willingness, saving you from applying to roles that won't consider OPT candidates. Browsing QA engineer listings there gives you a faster path to employers already open to international hires.
Quality Assurance Engineer OPT: Frequently Asked Questions
Do Quality Assurance Engineer jobs qualify for the STEM OPT extension?
Yes, if your degree is in a STEM field such as computer science, information technology, or software engineering. The STEM OPT extension adds 24 months to your standard 12-month OPT period, giving you up to three years of work authorization. Confirm your specific degree program appears on the official STEM designated degree program list maintained by ICE before relying on this.
How do I find Quality Assurance Engineer employers who sponsor OPT?
Migrate Mate is built specifically for F-1 OPT and visa-seeking candidates, so QA engineer listings there are already filtered for sponsorship openness. Beyond that, target mid-to-large software companies and SaaS employers with dedicated engineering teams, since QA is a core function for them and visa sponsorship is a normal part of their hiring process.
Can I work as a QA Engineer on OPT if my degree is not in computer science?
It depends on your degree field and how the employer classifies the role. If your degree is in a STEM-adjacent field like electrical engineering or mathematics, many QA roles will still qualify. If your degree is outside STEM entirely, you can still work on standard 12-month OPT, but you won't be eligible for the 24-month STEM extension.
Do QA Engineer roles typically lead to H-1B sponsorship?
Quality Assurance Engineer is a recognized specialty occupation under the H-1B visa, and many software companies sponsor QA engineers regularly. Your odds improve significantly if you work in test automation rather than purely manual QA, since automation skills are specialized, harder to source locally, and easier for employers to justify in an H-1B petition.
What should I do if a QA Engineer job posting doesn't mention visa sponsorship?
Silence on sponsorship in a job posting does not mean the employer won't sponsor. Many companies omit it from listings and decide case by case. Apply if the role is a strong match, and raise your OPT status and future sponsorship needs during the offer stage or late in the interview process once mutual interest is established.