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 JobsINTRODUCTION
Under minimal supervision, this role performs a wide range of Quality Assurance activities to ensure compliance across manufacturing, facilities, utilities, environmental programs, and quality systems. Responsibilities include review and approval of critical GMP documentation, leading investigations, supporting audits, and providing lot disposition for product release.
Responsibilities
- Review and approve product master records (MPs).
- Approve process validation protocols and reports for manufacturing processes.
- Approve Environmental Characterization reports.
- Approve planned incidents and support incident triage activities.
- Review and approve Work Orders and EMS/BMS alarms.
- Approve nonconformance investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
- Own and maintain site quality program procedures.
- Review and assess risk assessments.
- Lead investigations and ensure timely, compliant closure.
- Lead site audits and support internal/external inspections.
- Evaluate compliance issues using advanced data trending and analysis.
- Serve as designee for QA management on local change control review boards (CCRB).
- Support automation, facilities, and environmental programs.
- Represent QA on New Product Introduction (NPI) teams.
- Collaborate with Manufacturing, Process Development, Validation, Quality Control, Engineering, Facilities, Utilities, and Contractors.
- Coordinate with external resources when higher‑level expertise is required.
- Interact effectively with regulatory agencies.
BASIC QUALIFICATIONS
- Doctorate OR
- Master’s + 2 years of directly related experience OR
- Bachelor’s + 4 years of directly related experience OR
- Associate’s + 8 years of directly related experience OR
- High School/GED + 10 years of directly related experience
PREFERRED QUALIFICATIONS
- Experience performing on‑the‑floor Plant Quality Assurance (PQA) activities, including review, approval, and tracking of cGMP processes, procedures, testing methods, batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise.
- Expertise in deviations, CAPAs, change controls, and validation activities.
- Experience with procedural compliance and initiate deviation records during on‑the‑floor triage.
- Experience supporting audits and inspections as part of the audit/inspection management team.
- Experience with computer systems validation or computer systems quality assurance (medical device or consulting background preferred).
- Experience with validation of GxP applications (VMP, IQ, RA/GxP assessment, OQ, PQ, test scripts, summary reports).
- Experience serving as Quality Contact for complex new‑product projects.
- Experience in commissioning and qualification.
- Project management and organizational skills.
BENEFITS
- Non‑Standard Shift
- 6‑month contract with possible extension
INTRODUCTION
Under minimal supervision, this role performs a wide range of Quality Assurance activities to ensure compliance across manufacturing, facilities, utilities, environmental programs, and quality systems. Responsibilities include review and approval of critical GMP documentation, leading investigations, supporting audits, and providing lot disposition for product release.
Responsibilities
- Review and approve product master records (MPs).
- Approve process validation protocols and reports for manufacturing processes.
- Approve Environmental Characterization reports.
- Approve planned incidents and support incident triage activities.
- Review and approve Work Orders and EMS/BMS alarms.
- Approve nonconformance investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
- Own and maintain site quality program procedures.
- Review and assess risk assessments.
- Lead investigations and ensure timely, compliant closure.
- Lead site audits and support internal/external inspections.
- Evaluate compliance issues using advanced data trending and analysis.
- Serve as designee for QA management on local change control review boards (CCRB).
- Support automation, facilities, and environmental programs.
- Represent QA on New Product Introduction (NPI) teams.
- Collaborate with Manufacturing, Process Development, Validation, Quality Control, Engineering, Facilities, Utilities, and Contractors.
- Coordinate with external resources when higher‑level expertise is required.
- Interact effectively with regulatory agencies.
BASIC QUALIFICATIONS
- Doctorate OR
- Master’s + 2 years of directly related experience OR
- Bachelor’s + 4 years of directly related experience OR
- Associate’s + 8 years of directly related experience OR
- High School/GED + 10 years of directly related experience
PREFERRED QUALIFICATIONS
- Experience performing on‑the‑floor Plant Quality Assurance (PQA) activities, including review, approval, and tracking of cGMP processes, procedures, testing methods, batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise.
- Expertise in deviations, CAPAs, change controls, and validation activities.
- Experience with procedural compliance and initiate deviation records during on‑the‑floor triage.
- Experience supporting audits and inspections as part of the audit/inspection management team.
- Experience with computer systems validation or computer systems quality assurance (medical device or consulting background preferred).
- Experience with validation of GxP applications (VMP, IQ, RA/GxP assessment, OQ, PQ, test scripts, summary reports).
- Experience serving as Quality Contact for complex new‑product projects.
- Experience in commissioning and qualification.
- Project management and organizational skills.
BENEFITS
- Non‑Standard Shift
- 6‑month contract with possible extension
See all 183+ STEM OPT Quality Assurance Specialist Jobs
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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.
Frequently 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.