Quality Specialist Jobs for OPT Students
Quality Specialist roles are a strong fit for F-1 OPT students with backgrounds in engineering, manufacturing, or life sciences. Most positions qualify as STEM OPT extensions, giving you up to three years of work authorization. Employers in regulated industries like medical devices, pharmaceuticals, and aerospace routinely hire OPT candidates for quality assurance and compliance work.
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Get Access To All JobsQuality Specialist I
Position Summary
- Shift: Monday – Friday 8am-4:30pm
- 100% on-site
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
The Quality Assurance Specialist I supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements.
The role:
- Participate in continuous improvement initiatives to enhance process, systems, and procedures related to quality management
- Review QC data for completeness and acceptability
- Approve Release packets with supervision
- Lead Investigator for Deviations and Complaints
- Hosting CAPA review and deviation management meetings
- Reviewing /approve change controls and change actions with supervision
The candidate:
- Bachelor’s degree in a scientific discipline or equivalent knowledge and experience.
- High school degree with 2+ years of Quality Assurance experience in a GMP manufacturing environment.
- Receives instruction, guidance and direction from others
- Uses existing procedures to solve routine problems
- Ability to identify aberrant data and potential quality/compliance concerns escalating to management
- Ability to work effectively under pressure to meet deadlines
- Has sufficient skills and knowledge in the use of computers and associated computer technology.
Why you should join Catalent:
- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Quality Specialist I
Position Summary
- Shift: Monday – Friday 8am-4:30pm
- 100% on-site
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
The Quality Assurance Specialist I supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements.
The role:
- Participate in continuous improvement initiatives to enhance process, systems, and procedures related to quality management
- Review QC data for completeness and acceptability
- Approve Release packets with supervision
- Lead Investigator for Deviations and Complaints
- Hosting CAPA review and deviation management meetings
- Reviewing /approve change controls and change actions with supervision
The candidate:
- Bachelor’s degree in a scientific discipline or equivalent knowledge and experience.
- High school degree with 2+ years of Quality Assurance experience in a GMP manufacturing environment.
- Receives instruction, guidance and direction from others
- Uses existing procedures to solve routine problems
- Ability to identify aberrant data and potential quality/compliance concerns escalating to management
- Ability to work effectively under pressure to meet deadlines
- Has sufficient skills and knowledge in the use of computers and associated computer technology.
Why you should join Catalent:
- Competitive medical benefits and 401K
- 152 hours PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
How to Get Visa Sponsorship as a Quality Specialist
Target STEM-designated programs
Quality Specialist roles in engineering and sciences typically qualify for the 24-month STEM OPT extension. Confirm your degree CIP code is STEM-eligible before applying so you can honestly communicate your full three-year authorization window to employers.
Lead with regulatory knowledge
Employers in FDA-regulated industries prioritize candidates who understand ISO 9001, GMP, or 21 CFR Part 820. Highlight any coursework, lab experience, or internships involving quality management systems, audits, or corrective action processes directly in your resume summary.
Address OPT proactively in applications
Hiring managers often hesitate because they misunderstand OPT. State clearly in your cover letter that OPT requires no employer sponsorship cost or petition during the authorization period, and that STEM extension gives them three years of work authorization.
Pursue quality certifications
A Certified Quality Improvement Associate or Six Sigma Green Belt certification signals serious commitment to the field. These credentials reduce employer hesitation about OPT candidates because they demonstrate measurable professional investment beyond your degree alone.
Focus on industries with high OPT hire rates
Medical devices, automotive, aerospace, and contract manufacturing firms consistently hire OPT students for quality roles. These industries operate under strict compliance requirements and value technically trained candidates, making them more comfortable navigating work authorization paperwork.
Quantify quality impact on your resume
Generic quality descriptions lose hiring managers fast. Cite specific outcomes: defect reduction percentages, audit pass rates, or process improvement results. Concrete metrics make your application competitive against domestic candidates and demonstrate real-world quality systems experience.
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Get Access To All JobsFrequently Asked Questions
Do Quality Specialist employers need to sponsor F-1 OPT students?
No. During your OPT period, you already have work authorization through USCIS. Your employer does not file any petition or pay any sponsorship fee. For STEM OPT extension, your employer must be E-Verify enrolled and sign a training plan, but that is not the same as visa sponsorship. You can browse OPT-friendly Quality Specialist openings directly on Migrate Mate.
Does a Quality Specialist role qualify for the STEM OPT extension?
Most do, provided your underlying degree is in a STEM-designated field such as industrial engineering, mechanical engineering, chemistry, or biology. The job itself does not need to be classified as STEM, but it must be directly related to your degree program. Review your degree's CIP code with your DSO before applying to confirm STEM eligibility.
What degree backgrounds are most relevant for Quality Specialist OPT jobs?
Industrial engineering, mechanical engineering, biomedical engineering, chemistry, biochemistry, and manufacturing technology are the most common degree backgrounds. Life sciences degrees are especially relevant for pharmaceutical and medical device quality roles. Employers in regulated industries expect your coursework to connect directly to quality management, statistics, or process control concepts.
How does the 90-day unemployment rule affect Quality Specialist job searches?
USCIS allows no more than 90 cumulative days of unemployment during standard OPT and an additional 60 days during STEM OPT extension. Quality Specialist roles can take time to secure because many positions require industry-specific experience. Start your search early, track your unemployment days carefully, and target regulated industries where hiring timelines tend to move faster.
Can I work for a staffing agency or contract firm as a Quality Specialist on OPT?
Yes, third-party placement is generally permitted on OPT as long as there is a bona fide employer-employee relationship and the work is related to your degree. For STEM OPT specifically, the end client site must also be E-Verify enrolled. Confirm with your DSO before accepting any contract arrangement to ensure your training plan meets USCIS requirements.
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