STEM OPT Quality Assurance Specialist Jobs
Quality Assurance Specialist roles in testing, process validation, and regulatory compliance qualify for STEM OPT authorization when your degree aligns with an approved CIP code. The 24-month STEM OPT extension gives you up to 36 months total, provided your employer is enrolled in E-Verify and you file a compliant I-983 training plan.
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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 94+ 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 STEM OPT Authorization as a Quality Assurance Specialist
Verify your CIP code covers QA
Check your degree's Classification of Instructional Programs code against STEM OPT's approved CIP code list. Engineering technology, industrial engineering, and computer science codes commonly support Quality Assurance Specialist roles, but applied biology or chemistry degrees also qualify if the job involves process validation or lab quality systems.
Build an I-983 that reflects QA work
Your training plan must map specific QA tasks, such as defect tracking, root cause analysis, or ISO audit participation, to learning objectives tied to your STEM degree. Generic descriptions get flagged by DSOs. Align each objective to a measurable outcome so your DSO can approve the plan without revision.
Filter employers by E-Verify enrollment status
Before applying, confirm the employer is enrolled in E-Verify by searching the E-Verify employer search tool. Many mid-size QA employers in manufacturing and medical devices aren't enrolled, which disqualifies them from hiring STEM OPT students regardless of their willingness to sponsor.
Target QA roles in regulated industries
Pharmaceutical, aerospace, and semiconductor employers file LCAs consistently for Quality Assurance Specialist positions because FDA and FAA compliance requirements create permanent QA headcount. Search DOL's OFLC disclosure data to identify which employers filed for this occupation in your target metro area.
Use Migrate Mate to find verified QA openings
Migrate Mate filters Quality Assurance Specialist jobs by employers with confirmed E-Verify enrollment and LCA filing history, so you're not wasting applications on companies that can't legally hire STEM OPT students. Narrow by industry and location to match your degree's qualifying CIP code to the actual role requirements.
Negotiate your start date around OPT filing windows
USCIS recommends filing your STEM OPT extension application up to 90 days before your initial OPT end date. Confirm with your DSO that your I-20 update and I-765 are submitted before your EAD expires so there's no gap between your initial OPT period and the approved 24-month extension.
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Find Quality Assurance Specialist JobsFrequently Asked Questions
Does a Quality Assurance Specialist role qualify for the STEM OPT extension?
It depends on whether your degree's CIP code appears on the STEM OPT designated degree list and whether the QA role directly applies that field of study. Engineering technology, industrial engineering, chemistry, and computer science degrees commonly support QA positions in manufacturing and software. Review the O*NET profile for Quality Assurance Specialists to confirm the degree alignment before filing your extension request with your DSO.
Does my employer need to be enrolled in E-Verify before I start a QA job on STEM OPT?
Yes. E-Verify enrollment is a hard requirement for STEM OPT employers, not a recommendation. Your employer must be actively enrolled before you begin working, and enrollment must remain current throughout your 24-month extension period. You can verify enrollment status using the E-Verify employer search. If the employer isn't enrolled, they cannot legally employ you under STEM OPT regardless of their intent to sponsor future visas.
What should my I-983 training plan include for a Quality Assurance Specialist position?
Your I-983 must outline specific learning objectives tied to your STEM degree and connect them to the actual QA tasks you'll perform, such as failure mode analysis, statistical process control, audit preparation, or regulatory documentation. Generic descriptions aren't sufficient. Both you and your employer's authorized representative must sign the plan, and your DSO must approve it before USCIS processes your extension. Update the plan if your role or responsibilities change materially.
How do I find Quality Assurance Specialist jobs where the employer can legally hire STEM OPT students?
Search Migrate Mate, which filters job listings by employers with verified E-Verify enrollment and LCA filing history for Quality Assurance Specialist roles. This saves time compared to applying broadly and discovering late in the process that an employer isn't enrolled in E-Verify or has never filed an LCA for this occupation, which would prevent you from starting work on your STEM OPT EAD.
What happens to my STEM OPT authorization if my employer loses E-Verify enrollment mid-extension?
If your employer's E-Verify participation is terminated during your 24-month extension, your authorization to work for that employer under STEM OPT ends. You have a 180-day cap-gap or grace period window to find a new compliant employer, update your training plan, and continue authorized employment. USCIS treats this as a material change to your training conditions, so notify your DSO immediately and document the transition to protect your status.
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