OPT QA Specialist Jobs
QA Specialist 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 occupations, making you eligible for the 24-month STEM OPT extension. Employers filing H-1B visa petitions regularly sponsor QA Specialists for long-term work authorization.
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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 412+ OPT QA Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT QA Specialist Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a QA Specialist
Verify your degree qualifies for STEM OPT
QA Specialist roles often qualify for the 24-month STEM OPT extension, but your degree field must appear on the STEM Designated Degree Program List. Confirm your CIP code with your DSO before applying to roles requiring extended authorization.
Target employers with a QA H-1B sponsorship track record
Search OFLC disclosure data to identify companies that have filed H-1B visa petitions for QA or software testing roles in the past two years. Past sponsorship behavior is the strongest signal that an employer will support your long-term authorization.
Address your OPT timeline proactively with hiring managers
Mention your OPT authorization dates early in the process, not at the offer stage. QA teams with hiring cycles tied to product release schedules need to plan around your work authorization window to avoid onboarding delays.
Highlight automation skills to strengthen your candidacy
Employers sponsoring QA Specialists for H-1B status need to justify the specialty occupation classification. Demonstrating expertise in test automation frameworks like Selenium or Cypress makes your role easier to classify and your petition stronger.
Apply to mid-size software companies, not just large enterprises
Mid-size software and SaaS companies frequently sponsor QA hires and move faster than large corporations. They often have fewer internal bureaucratic hurdles around OPT and H-1B paperwork, making them practical targets during your OPT window.
Get your EAD card details ready before interviews progress
Have your EAD card number, expiration date, and STEM extension eligibility confirmed before offer negotiations begin. Employers appreciate candidates who can answer work authorization questions clearly and without delay, which signals professionalism and preparation.
QA Specialist OPT: Frequently Asked Questions
Does a QA Specialist role qualify for the STEM OPT extension?
It depends on your degree field, not just the job title. QA Specialist positions commonly qualify when your degree is in computer science, information systems, software engineering, or a related STEM field listed on the designated degree program list. Confirm your CIP code with your DSO before assuming eligibility, since degrees in non-STEM fields will not qualify even if the job itself involves technical work.
Will employers sponsor a QA Specialist on OPT for an H-1B?
Many do, particularly software companies and tech-forward employers who rely on structured QA teams. The key is finding employers with a documented history of H-1B sponsorship for QA or software testing roles. Migrate Mate filters for OPT-friendly employers, so you can focus your search on companies already open to sponsorship rather than guessing from job listings alone.
Can a QA Specialist role be classified as a specialty occupation for H-1B purposes?
Yes, when the position requires a specific bachelor's degree or higher in a relevant technical field. Roles focused on manual testing without a technical degree requirement have faced more scrutiny in H-1B adjudications. Positions requiring expertise in test automation, API testing, or performance engineering, backed by a computer science or engineering degree, have a much clearer path to specialty occupation classification.
What should I do if my OPT expires before the H-1B cap-gap period starts?
If your employer files an H-1B petition by April 1 before your OPT expires, the cap-gap provision automatically extends your work authorization through September 30. If your OPT expires before April 1 and no petition is filed in time, you cannot continue working. Planning your job search and offer timing around the H-1B filing window is critical for QA Specialists relying on this transition.
Are contract or staffing agency QA roles a good option during OPT?
They can be, but they come with tradeoffs. Contract roles through staffing agencies count toward your OPT work requirement, and some agencies do sponsor H-1B petitions. However, agency sponsorship is less predictable than direct employer sponsorship, and third-party placement arrangements can complicate H-1B specialty occupation petitions. Direct-hire QA roles at product companies generally offer a more stable path to long-term sponsorship.