H-1B Visa Quality Assurance Specialist Jobs
Quality Assurance Specialist roles qualify for H-1B sponsorship when the position requires a bachelor's degree or higher in a directly related field such as engineering, computer science, or quality management. Employers must file a Labor Condition Application with the DOL and submit Form I-129 to USCIS before your start date.
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Get Access To All JobsWork 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.
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.
See all 359+ Quality Assurance Specialist jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Quality Assurance Specialist roles.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Quality Assurance Specialist
Verify your degree field matches the role
QA Specialist roles require a degree in a directly related field, such as industrial engineering, computer science, or quality management. A general business degree alone may not satisfy USCIS's specialty occupation standard for this job title.
Check employer LCA filing history by role
Use Migrate Mate to filter employers by verified DOL Labor Condition Application filings for QA Specialist roles. This shows you which companies have a real track record of sponsoring this specific occupation, not just H-1B filings generally.
Target E-Verify enrolled employers early
If you're transitioning from OPT or STEM OPT, your employer must be enrolled in E-Verify. Confirm enrollment before accepting an offer, since unenrolled employers can't legally employ you during cap-gap or OPT periods.
Document your QA methodology credentials
Certifications like ASQ CQE, ISTQB, or Six Sigma are not required by USCIS but strengthen the specialty occupation argument in your I-129 petition. Assemble these before the lottery so your employer's attorney can build the strongest petition.
Understand how prevailing wage affects your offer
Your employer's LCA must certify wages at or above the DOL prevailing wage for your job title and work location. Run your role and zip code through OFLC Wage Search before finalizing an offer to confirm the salary is compliant.
Plan around the 60-day grace period when switching jobs
If you're changing QA roles between H-1B employers, USCIS allows a 60-day grace period after your previous position ends. Your new employer must file an H-1B transfer petition before that window closes or your status lapses.
Quality Assurance Specialist jobs are hiring across the US. Find yours.
Find Quality Assurance Specialist JobsQuality Assurance Specialist H-1B Visa: Frequently Asked Questions
Does a Quality Assurance Specialist role qualify as a specialty occupation for H-1B purposes?
A QA Specialist role qualifies as a specialty occupation when the position normally requires a bachelor's degree or higher in a specific field such as engineering, computer science, or quality management. If the job description accepts any degree field or frames the degree as preferred rather than required, USCIS may issue a Request for Evidence challenging specialty occupation status. Your employer's petition should document that the role is complex enough to demand that specialized degree.
Which employers are most likely to sponsor H-1B visas for QA Specialist roles?
Employers in software development, medical device manufacturing, aerospace, and semiconductor fabrication regularly sponsor H-1B visas for QA Specialists because those industries require documented compliance processes that demand specialized degree backgrounds. Migrate Mate lets you search specifically for employers with verified LCA filings for QA roles, so you can focus on companies with an actual sponsorship track record rather than guessing from job postings.
Can I transfer my H-1B to a new QA employer without restarting the cap process?
Yes. H-1B portability under AC21 lets you transfer to a new employer in a same or similar occupational classification without re-entering the lottery, as long as your new employer files a transfer petition while your current H-1B is valid. QA Specialist roles generally fall under the same SOC code cluster, but your new employer's attorney should confirm the occupational classification matches before filing to avoid a denial.
What happens to my H-1B status if my QA role is restructured or eliminated?
If your position is eliminated, your H-1B status ends with your employment, and USCIS allows a 60-day grace period to find a new sponsoring employer, change to another valid status, or depart the U.S. Your previous employer is also required to pay for your return transportation to your home country. Acting within the 60-day window is critical because any day beyond it makes you out of status.
Does remote work affect H-1B sponsorship for QA Specialist positions?
Yes. H-1B status is tied to specific worksite locations listed in your employer's LCA. If you work remotely from a location not covered by the original LCA, your employer must file an amended LCA and potentially an amended H-1B petition with USCIS before you begin working at that location. QA roles that shift between client sites or require travel should have a blanket LCA covering those locations, which your employer's immigration counsel should verify.
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