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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Work Schedule
12 hr shift/nights
Environmental Conditions
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Standing for full shift
Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
GROUP/DIVISION SUMMARY
The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.
Position Summary
In this position, you’ll drive quality execution across the sterile operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development services products. Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. Typical hours are 6p - 6a, on a 2-2-3 rotation.
Key Responsibilities:
- Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies, assure quality, and compliance per site procedures and cGMPs.
- Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique
- Champions quality culture by aiding personnel in understanding application of policies and controls
- Participates in RAPID event response and provides quality guidance for deviation events
- Advances deviation events to the appropriate area and quality management
- Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity
- Performs quality review and approval of deviation and change control of moderate to high complexity
- Participates as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity
- Performs quality batch record review
- Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives
Qualifications
- A minimum of 4 years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing
- Previous experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred, experience in other regulated environments may be considered (i.e. ISO 9001)
- Ability to capture data, analyze & troubleshooting process issues, equipment problems along with production leadership
- Ability to troubleshoot process and equipment issues
- Hard-working, demonstrated ownership & responsibility.
- Ability to lead, support & empower a team/peers
- Technical Writing experience
- Professional certifications (ex: CQA) and training (Six Sigma) are a plus
- Primary responsibilities require consistent production floor presence which necessitate physical fitness for prolonged standing, walking, and repetitive bending, and aseptic and non-aseptic gowning.
Education:
Bachelor’s degree, preferably in technology, engineering or microbiology related field required. Equivalent combinations of education, training, and relevant work experience may be considered.
Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time. Manipulation (lift, carry, move) of light to medium weights of 10–35-pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.
BENEFITS
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation. Apply today!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/disability access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
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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.