STEM OPT QA Specialist Jobs
QA Specialist roles in software testing, manufacturing quality control, and process validation directly align with STEM degrees in computer science, engineering, and applied sciences. Your 24-month STEM OPT extension applies here, giving you up to 36 months total, provided your employer is enrolled in E-Verify and your training plan ties quality assurance duties to your degree field.
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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 76+ QA Specialist jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new QA Specialist roles.
Get Access To All JobsTips for Finding STEM OPT Authorization as a QA Specialist
Verify your CIP code covers QA
Check that your degree's Classification of Instructional Programs code maps to a STEM-designated field before applying. Computer science, industrial engineering, and systems engineering CIP codes all support QA Specialist roles, but general business degrees typically don't qualify.
Confirm E-Verify status before applying
Ask every recruiter whether the company is enrolled in E-Verify before your first interview. A QA role at a company that isn't enrolled cannot support your STEM OPT extension, no matter how well the job matches your degree.
Tie your I-983 duties to your STEM field
Your training plan must connect specific QA tasks, such as defect analysis, test automation, or statistical process control, to concepts from your STEM degree. Vague descriptions like 'quality assurance support' are the leading reason DSOs flag I-983 plans for revision.
Target employers with active DOL LCA filings
Use Migrate Mate to filter QA Specialist roles by employers who have filed Labor Condition Applications, which signals active experience hiring workers on visa-based authorization and familiarity with the E-Verify enrollment requirement.
Use OFLC Wage Search to benchmark your offer
Look up the prevailing wage for QA Specialist roles in your target metro area using OFLC Wage Search before evaluating any offer. Employers filing an LCA must pay at least the prevailing wage, so knowing the Level I and Level II figures tells you whether an offer is compliant.
QA Specialist jobs are hiring across the US. Find yours.
Find QA Specialist JobsFrequently Asked Questions
Does my STEM degree qualify me for the 24-month STEM OPT extension as a QA Specialist?
It depends on your specific degree, not the job title. Your degree must appear on the USCIS STEM Designated Degree Program List and carry a qualifying CIP code. Degrees in computer science, industrial engineering, electrical engineering, and statistics commonly support QA Specialist roles. A general management or communications degree won't qualify even if your job involves quality systems work. Confirm your CIP code with your DSO before applying for the extension.
Is E-Verify enrollment required for my QA Specialist employer to support my STEM OPT?
Yes. E-Verify enrollment is a hard requirement for any employer sponsoring a STEM OPT extension, regardless of company size or industry. Before accepting a QA Specialist offer, ask HR to confirm the company's E-Verify Company ID. If the employer isn't enrolled, they must complete enrollment before you can file the extension. You can search for roles at verified employers on Migrate Mate, which filters listings by employers with relevant filing history.
What should my I-983 training plan include for a QA Specialist role?
Your I-983 must describe how the specific QA duties in your role apply knowledge from your STEM degree. Generic job descriptions aren't enough. Include concrete learning objectives tied to your major, such as applying statistical methods to defect rate analysis, using software testing frameworks tied to your computer science coursework, or implementing process controls grounded in industrial engineering principles. Your DSO and employer both sign the plan, and USCIS can audit it, so specificity matters.
Can I switch QA Specialist employers while on STEM OPT?
Yes, but you must follow the correct process. Your new employer must also be enrolled in E-Verify, the role must still relate to your STEM degree, and you must file an updated I-983 training plan with your DSO before your start date. Your DSO will issue a new I-20 reflecting the change. Working for a non-E-Verify employer, even briefly, is a violation that can affect your status and future visa eligibility.
How does cap-gap work if my employer sponsors my H-1B during my QA Specialist STEM OPT?
If your STEM OPT is still valid on April 1 and your employer files a timely H-1B petition on your behalf, cap-gap automatically extends your work authorization through September 30. If your petition is selected in the lottery and approved, your H-1B status begins October 1. If it isn't selected, your authorization ends September 30. You can continue working as a QA Specialist throughout the cap-gap period as long as your employer filed before your EAD expired.
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