OPT Quality Assurance Associate Jobs
Quality Assurance Associate roles are a strong fit for F-1 OPT students with degrees in computer science, engineering, or information systems. Most positions qualify as STEM OPT extensions, giving you up to 36 months of work authorization. Employers in software, manufacturing, and healthcare regularly hire QA associates without requiring prior H-1B visa sponsorship commitments.
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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 Quality Assurance Associate Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Quality Assurance Associate Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Quality Assurance Associate
Target STEM-designated employers first
QA Associate roles at software and tech companies almost always qualify for the 24-month STEM OPT extension. Prioritize employers with an active E-Verify enrollment, which is required for STEM OPT and signals they have a process for international students.
Frame your degree as a direct qualifier
Hiring managers often assume QA is purely experience-based. Connect your computer science, engineering, or information systems degree directly to the role by mentioning coursework in software testing, systems analysis, or quality methods in your cover letter and resume.
Highlight testing tools and methodologies upfront
QA hiring decisions move fast. Put tools like Selenium, JIRA, TestRail, or Postman in your resume summary, not buried in a skills section. Employers scanning for technical fit need to see your toolkit before deciding whether to sponsor your continued authorization.
Ask about OPT early, but frame it correctly
Raise your work authorization status before the offer stage, not after. Say you are currently authorized on OPT and eligible for a STEM extension, which requires E-Verify enrollment. This gives employers a concrete, low-cost action rather than an open-ended sponsorship commitment.
Use your training plan to demonstrate structure
STEM OPT requires a formal training plan with your employer. Present this proactively as a benefit. Employers see it as a structured onboarding framework, not a burden. QA roles map naturally to measurable learning objectives, making the plan easy to complete.
Focus on industries with high QA hiring volume
Software, medical devices, pharmaceuticals, and aerospace all have compliance-driven QA needs and are accustomed to sponsoring international employees. These industries hire QA associates in volume and are more likely to have established immigration processes already in place.
Quality Assurance Associate OPT: Frequently Asked Questions
Does a Quality Assurance Associate role qualify for the STEM OPT extension?
Most QA Associate positions qualify for the 24-month STEM OPT extension if your degree is in a STEM-designated field such as computer science, engineering, or information systems. The role must be directly related to your degree, and your employer must be enrolled in E-Verify. Review your job offer against your degree field before assuming automatic eligibility.
Where can I find Quality Assurance Associate jobs that are open to OPT students?
Migrate Mate is built specifically for F-1 OPT students and filters jobs by visa sponsorship willingness, so you are not wasting applications on employers who will not consider international candidates. Browsing QA roles on Migrate Mate lets you focus on companies already familiar with OPT work authorization requirements.
Do Quality Assurance Associate employers typically sponsor H-1B visas after OPT?
It varies by employer size and industry. Large software companies, medical device manufacturers, and aerospace firms with established HR and legal teams are more likely to sponsor H-1B visa petitions for QA associates they have invested in training. Smaller companies may not have the infrastructure. Asking about long-term visa support during the offer stage is reasonable and expected.
What degree fields count as STEM-eligible for a QA Associate role?
Computer science, electrical engineering, mechanical engineering, industrial engineering, information systems, and applied mathematics are all commonly STEM-designated fields that support a QA Associate STEM OPT extension. Your specific degree program must appear on the DHS STEM Designated Degree Program List, which your Designated School Official can confirm before you accept an offer.
How much time does it take to get STEM OPT approved for a QA Associate job?
You must file your STEM OPT extension application with USCIS at least 90 days before your initial OPT expires. USCIS standard processing takes two to five months, so starting early is essential. If approved on time, you receive a 180-day automatic cap-gap period that keeps you work-authorized while the application is pending. Premium processing is not available for OPT extensions.