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 JobsWhat we offer
Explore a world of opportunities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable. At Evonik, you have the chance to explore, thrive, and grow alongside 33,000 colleagues. Among attractive career paths and high-quality development programs, we not only offer performance-based remuneration and occupational health benefits but also hybrid and flexible working environments with #SmartWork. Bring your fresh perspective, develop your strengths, break out your mold, and find a career that fits your dreams with us.
Click on the link below to learn what our employees have to say about Evonik:
https: //careers.evonik.com/en/about/meet-the-team/
Meet the Team - Evonik Industries
Want to know what it’s like to work at Evonik?
This position is responsible for providing quality and technical support to the production team providing oversight to manufacturing rooms and laboratories by reviewing and approving data and all other Quality management System documentation. This position will be required to review manufacturing batch production records and supporting QC data. This position may be required to review and approve validation documentation, prior to and after execution.
Responsibilities
- Perform room clearance activities before and during manufacturing campaigns to ensure cGMP compliance.
- Review manufacturing documentation and perform final disposition of raw materials, fill/finish components, and batch records.
- Review room cleaning logs and supporting documentation for GMP compliance.
- Review analytical data supporting site utilities, including WFI, clean steam, nitrogen, and other critical systems.
- Review environmental monitoring data to ensure cleanroom compliance and product quality.
- Review and approve change control documentation in accordance with quality system requirements.
- Provide on-the-floor QA support during manufacturing campaigns for PDS Products, PDS Services, and MDS operations.
- Provide on-call quality support to address manufacturing issues and maintain production continuity.
- Lead product quality and quality system improvement initiatives using data-driven analysis.
- Analyze quality metrics, identify improvement opportunities, and support continuous improvement projects while assisting with additional business-critical activities as needed.
REQUIREMENTS
- Bachelor's degree in Chemistry, Biology, Engineering, or another STEM field preferred; equivalent relevant experience may be substituted.
- 2–5 years of experience in pharmaceutical or medical device manufacturing, including at least 1 year in a Quality Assurance role.
- Working knowledge of FDA cGMP and/or Quality System Regulations (QSR), with experience supporting validation activities, including process validation.
- Strong technical, analytical, and problem-solving skills, including experience with applied statistics and quality investigations.
- Proficient in Microsoft Office (Word, Excel, Access) with excellent attention to detail, organizational, communication, and interpersonal skills.
The Evonik Group adopts an Equal Employment Opportunity (EEO) approach. Candidates are assessed based on their educational qualifications, experience, job competencies and potential and shall not be discriminated against on the basis of race, ethnicity, age, gender, religion, nationality, disability or sexual orientation or other classifications protected by local, state, or provincial regulations.
Your Application
To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at www.evonik.com/en/careers.html.
Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations.
Your Talent Acquisition Manager:
Kelvin Seals
Company is
Evonik Corporation
What we offer
Explore a world of opportunities with us. Look ahead with us and help shape innovative solutions to make our world more sustainable and life healthier, more vibrant and more comfortable. At Evonik, you have the chance to explore, thrive, and grow alongside 33,000 colleagues. Among attractive career paths and high-quality development programs, we not only offer performance-based remuneration and occupational health benefits but also hybrid and flexible working environments with #SmartWork. Bring your fresh perspective, develop your strengths, break out your mold, and find a career that fits your dreams with us.
Click on the link below to learn what our employees have to say about Evonik:
https: //careers.evonik.com/en/about/meet-the-team/
Meet the Team - Evonik Industries
Want to know what it’s like to work at Evonik?
This position is responsible for providing quality and technical support to the production team providing oversight to manufacturing rooms and laboratories by reviewing and approving data and all other Quality management System documentation. This position will be required to review manufacturing batch production records and supporting QC data. This position may be required to review and approve validation documentation, prior to and after execution.
Responsibilities
- Perform room clearance activities before and during manufacturing campaigns to ensure cGMP compliance.
- Review manufacturing documentation and perform final disposition of raw materials, fill/finish components, and batch records.
- Review room cleaning logs and supporting documentation for GMP compliance.
- Review analytical data supporting site utilities, including WFI, clean steam, nitrogen, and other critical systems.
- Review environmental monitoring data to ensure cleanroom compliance and product quality.
- Review and approve change control documentation in accordance with quality system requirements.
- Provide on-the-floor QA support during manufacturing campaigns for PDS Products, PDS Services, and MDS operations.
- Provide on-call quality support to address manufacturing issues and maintain production continuity.
- Lead product quality and quality system improvement initiatives using data-driven analysis.
- Analyze quality metrics, identify improvement opportunities, and support continuous improvement projects while assisting with additional business-critical activities as needed.
REQUIREMENTS
- Bachelor's degree in Chemistry, Biology, Engineering, or another STEM field preferred; equivalent relevant experience may be substituted.
- 2–5 years of experience in pharmaceutical or medical device manufacturing, including at least 1 year in a Quality Assurance role.
- Working knowledge of FDA cGMP and/or Quality System Regulations (QSR), with experience supporting validation activities, including process validation.
- Strong technical, analytical, and problem-solving skills, including experience with applied statistics and quality investigations.
- Proficient in Microsoft Office (Word, Excel, Access) with excellent attention to detail, organizational, communication, and interpersonal skills.
The Evonik Group adopts an Equal Employment Opportunity (EEO) approach. Candidates are assessed based on their educational qualifications, experience, job competencies and potential and shall not be discriminated against on the basis of race, ethnicity, age, gender, religion, nationality, disability or sexual orientation or other classifications protected by local, state, or provincial regulations.
Your Application
To ensure that your application is proceeded as quickly as possible and to protect the environment, please apply online via our careers portal. Further information about Evonik as Employer can be found at www.evonik.com/en/careers.html.
Please address your application to the Talent Acquisition Manager, stating your earliest possible starting date and your salary expectations.
Your Talent Acquisition Manager:
Kelvin Seals
Company is
Evonik Corporation
See all 237+ 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.