OPT Quality Control Specialist Jobs
Quality Control Specialist roles are a strong fit for F-1 OPT students with degrees in engineering, chemistry, biology, or manufacturing-related fields. Most positions qualify as STEM OPT extensions, giving you up to 36 months of work authorization. Employers in food, pharma, and manufacturing industries regularly hire OPT candidates for these roles.
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CTSI CLINICAL RESEARCH SERVICE (IN-PCIR-IUINA)
Job Summary
The Clinical Quality Assurance Specialist is responsible for the functions of the Indiana Clinical and Translational Science Institute (CTSI) Clinical Research Centers (CRCs) and other CTSI cores as time allows. This position ensures the planning, coordination, control, and continuous improvement of processes and methods established to control the quality of clinical research studies conducted at the Indiana CTSI; furthermore, the Clinical Quality Assurance Specialist ensures adherence to agency regulations (FDA), Good Clinical Practices (GCP) industry guidelines, local regulations and Indiana University (IU) policies and procedures for the conduct of clinical research studies. This position works closely with Clinical Operations, Clinical Translation Science Laboratory (CTSL), Information Technology, and other supporting areas (e.g., Indiana University Health University Hospital including Investigational Drug Pharmacy-IDS, Riley Hospital and Goodman Hall) to help ensure active participation in continuous quality improvement activities.
General Responsibilities
- Develops and implements moderately complex project plans consistent with the requirements of current and new federal, state, and local regulations and statutes as well as the compliance policies of the university.
- Manages implemented project plans including maintenance of program documentation, performance of training, monitoring and auditing.
- Collaborates with key research and operational stakeholders at IU to identify research compliance gaps, find solutions to mitigate risks and implement project plans.
- Continuously monitors regulatory changes and determine impact on research community.
- Collaborates with the research community to disseminate information and develop solutions to address regulatory requirements and contribute to compliance decision making.
- Expands knowledge by managing and participating in various committee meetings and attending workshops and conferences.
Qualifications
Required
- Bachelor's degree (preferably in business, health services, or a related field).
Work Experience
Required
- 3 years of relevant work experience in a sponsored research, compliance, healthcare, or clinical setting.
Skills
Required
- Demonstrates ability to maintain confidential information.
- Demonstrates analytical skills.
- Excellent organizational skills.
- Proficient written and verbal communication skills.
- Demonstrates excellent judgment and decision making skills.
- Experience in a regulated environment.
- Excellent collaboration and team building skills.
- Maintains composure under pressure.
- Ability to work within tight time frames and meet strict deadlines.
Working Conditions / Demands
This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment and the campus. The person in this role must be able to perform the essential functions with or without an accommodation.
Work Location
Indianapolis, Indiana
Benefits Overview
For full-time staff employees, Indiana University offers a wide array of benefits including:
- Comprehensive medical and dental insurance
- Health savings account with generous IU contributions
- Healthcare and dependent care flexible spending accounts
- Basic group life insurance paid by IU
- Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death and dismemberment insurance
- Base retirement plan with generous IU contributions, subject to vesting
- Voluntary supplemental retirement plan options
- Tuition subsidy for employees and family members taking IU courses
- 10 paid holidays plus a paid winter break each year
- Generous paid time off plans
- Paid leave for new parents and IU-sponsored volunteer events
- Employee assistance program (EAP)
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.
Job Classification
Career Level: Career
FLSA: Exempt
Job Function: Research
Job Family: Research Compliance
Click here to learn more about Indiana University's Job Framework.
Posting Disclaimer
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
Equal Employment Opportunity
Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.
Campus Safety and Security
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.
Contact Us
Request Support
Telephone: 812-856-1234
Department
CTSI CLINICAL RESEARCH SERVICE (IN-PCIR-IUINA)
Job Summary
The Clinical Quality Assurance Specialist is responsible for the functions of the Indiana Clinical and Translational Science Institute (CTSI) Clinical Research Centers (CRCs) and other CTSI cores as time allows. This position ensures the planning, coordination, control, and continuous improvement of processes and methods established to control the quality of clinical research studies conducted at the Indiana CTSI; furthermore, the Clinical Quality Assurance Specialist ensures adherence to agency regulations (FDA), Good Clinical Practices (GCP) industry guidelines, local regulations and Indiana University (IU) policies and procedures for the conduct of clinical research studies. This position works closely with Clinical Operations, Clinical Translation Science Laboratory (CTSL), Information Technology, and other supporting areas (e.g., Indiana University Health University Hospital including Investigational Drug Pharmacy-IDS, Riley Hospital and Goodman Hall) to help ensure active participation in continuous quality improvement activities.
General Responsibilities
- Develops and implements moderately complex project plans consistent with the requirements of current and new federal, state, and local regulations and statutes as well as the compliance policies of the university.
- Manages implemented project plans including maintenance of program documentation, performance of training, monitoring and auditing.
- Collaborates with key research and operational stakeholders at IU to identify research compliance gaps, find solutions to mitigate risks and implement project plans.
- Continuously monitors regulatory changes and determine impact on research community.
- Collaborates with the research community to disseminate information and develop solutions to address regulatory requirements and contribute to compliance decision making.
- Expands knowledge by managing and participating in various committee meetings and attending workshops and conferences.
Qualifications
Required
- Bachelor's degree (preferably in business, health services, or a related field).
Work Experience
Required
- 3 years of relevant work experience in a sponsored research, compliance, healthcare, or clinical setting.
Skills
Required
- Demonstrates ability to maintain confidential information.
- Demonstrates analytical skills.
- Excellent organizational skills.
- Proficient written and verbal communication skills.
- Demonstrates excellent judgment and decision making skills.
- Experience in a regulated environment.
- Excellent collaboration and team building skills.
- Maintains composure under pressure.
- Ability to work within tight time frames and meet strict deadlines.
Working Conditions / Demands
This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment and the campus. The person in this role must be able to perform the essential functions with or without an accommodation.
Work Location
Indianapolis, Indiana
Benefits Overview
For full-time staff employees, Indiana University offers a wide array of benefits including:
- Comprehensive medical and dental insurance
- Health savings account with generous IU contributions
- Healthcare and dependent care flexible spending accounts
- Basic group life insurance paid by IU
- Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death and dismemberment insurance
- Base retirement plan with generous IU contributions, subject to vesting
- Voluntary supplemental retirement plan options
- Tuition subsidy for employees and family members taking IU courses
- 10 paid holidays plus a paid winter break each year
- Generous paid time off plans
- Paid leave for new parents and IU-sponsored volunteer events
- Employee assistance program (EAP)
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.
Job Classification
Career Level: Career
FLSA: Exempt
Job Function: Research
Job Family: Research Compliance
Click here to learn more about Indiana University's Job Framework.
Posting Disclaimer
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
Equal Employment Opportunity
Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.
Campus Safety and Security
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.
Contact Us
Request Support
Telephone: 812-856-1234
See all 448+ OPT Quality Control Specialist Jobs
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Get Access To All JobsTips for Finding OPT Sponsorship as a Quality Control Specialist
Verify your role qualifies for STEM OPT
Quality Control Specialist positions typically qualify for the 24-month STEM OPT extension if your degree is in engineering, chemistry, biology, or a related STEM field. Confirm your CIP code with your DSO before accepting an offer.
Target industries with consistent OPT hiring
Pharmaceutical, food manufacturing, medical device, and semiconductor companies hire Quality Control Specialists regularly and have established OPT and H-1B visa sponsorship pipelines. Prioritize employers with existing international hiring infrastructure over small firms.
Highlight relevant certifications on your resume
Certifications like Six Sigma, ASQ Certified Quality Technician, or ISO 9001 internal auditor credentials signal technical credibility to hiring managers and can offset concerns about OPT timelines when employers weigh candidates.
Address OPT early in recruiter conversations
Bring up your OPT status and STEM extension eligibility in the first recruiter call, not after an offer. Framing it proactively, with specifics about your authorization period, prevents late-stage rejections from employers unfamiliar with the process.
Use your practical training period strategically
If you are still completing your degree, CPT in a QC-adjacent internship builds direct experience and makes your OPT application stronger. Documented hands-on lab or inspection work substantially improves your competitiveness for full-time QC roles.
Browse OPT-friendly QC roles on Migrate Mate
Migrate Mate filters Quality Control Specialist jobs by visa sponsorship willingness, so you are not applying blindly to employers who will not hire OPT students. Use it to identify which companies are actively open to your work authorization status.
Quality Control Specialist OPT: Frequently Asked Questions
Do Quality Control Specialist jobs qualify for the STEM OPT extension?
Most Quality Control Specialist roles qualify for the 24-month STEM OPT extension if your degree is in a STEM-designated field such as engineering, chemistry, biology, or materials science. The job itself must also be directly related to your major. Confirm your CIP code and role alignment with your DSO before assuming eligibility, since job titles alone do not determine qualification.
How do I find Quality Control Specialist employers who hire OPT students?
Migrate Mate is built specifically for this. It surfaces Quality Control Specialist jobs at employers who are open to OPT work authorization, saving you from applying to companies that will reject international candidates outright. Pharmaceutical, food safety, and manufacturing companies tend to have the most established OPT hiring processes in this field.
What degree fields are most relevant for OPT Quality Control Specialist roles?
Employers most commonly hire QC Specialists with degrees in chemical engineering, industrial engineering, biology, biochemistry, food science, or materials science. These fields align with STEM OPT extension eligibility and match the technical requirements of QC work in manufacturing, pharma, and medical device environments. A degree in general business or non-STEM fields is less competitive for these positions.
Can I work as a Quality Control Specialist on pre-completion OPT?
Yes, if you have received pre-completion OPT authorization from USCIS, you can work in a Quality Control Specialist role as long as the position is directly related to your degree field. Pre-completion OPT has hour restrictions during the academic year, so confirm with your DSO that a full-time role is permitted given your enrollment status at the time.
What should I tell an employer about my OPT timeline during the hiring process?
Be specific. Tell the employer your OPT start date, end date, and whether you are eligible for the STEM extension. If you qualify for a total of 36 months of OPT, say that clearly. Many hiring managers misunderstand OPT and assume authorization is shorter than it is. Providing a clear written summary after your first recruiter call can prevent misunderstandings that cause delays or rejections later.