STEM OPT QA Specialist Jobs
QA Specialist roles in software testing, manufacturing quality control, and process validation directly align with STEM degrees in computer science, engineering, and applied sciences. Your 24-month STEM OPT extension applies here, giving you up to 36 months total, provided your employer is enrolled in E-Verify and your training plan ties quality assurance duties to your degree field.
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Get Access To All JobsSr. Quality Assurance Specialist
The Sr. QA Specialist is responsible for managing and documenting events / discrepancies associated with either product or process as well as managing / writing any investigations that may be a result of those events; processing and investigating customer/ consumer product complaints; preparing annual product reviews; tracking, trending and follow-up of the CAPA programs.
Position Summary
This position is 100% on-site at the St. Petersburg site.
St. Petersburg is our primary Softgel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.
This position will participate in the internal audit program, customer audits and may assist with Supplier Audits/Certification Programs.
The Role
- Assist in organizing and prioritizing the activities and schedule for the QA Specialists.
- Provides feedback to QA Supervisor and Manager on performance of QA Specialists.
- Responsible for actively identifying compliance enhancements/improvements and leading project to deliver solutions.
- Collaborates with management and supervisory personnel from operations, quality control and quality assurance to resolve problems affecting product quality; collaboration includes rating, investigating and following up with operators for non-conformance issues and working jointly towards resolution.
- Provide guidance and plan of action to the manufacturing floor when production events occur as defined by SOP and lead cross functional team to classify events and deviations of non-compliant issues according to procedures as defined by SOPs.
- Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
- Prepare annual product reports and ensure on time closure. Author/compile monthly, quarterly and annual summaries and metrics, including DRB (Deviation Review Board) presentation.
- Other duties as assigned.
The Candidate
- Bachelor’s Degree in science or Engineering required (Chemistry, Microbiology or Biology preferred) and a minimum of 3 years of related experience in QA pharmaceutical manufacturing and/or manufacturing pharmaceutical operation.
- Prior experience working with investigation writing, including root cause analysis and report writing a must.
- Prior experience with preparing annual product reviews preferred.
- Proficient to advance skills in Microsoft Office applications (Word, Excel, PowerPoint and Access). Working knowledge of cGMPs and/or OSHA regulations.
- Ability to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance. Be accessible to manufacturing floor and office staff and to use required office equipment. Vision requirements include to have 20/30 vision with or without corrective lenses, read written documents and frequent use of a computer monitor.
Why You Should Work At Catalent
- Spearhead exciting and innovative projects
- Fast-paced, dynamic environment
- High visibility to members at all levels of the organization
- 152 hours of PTO + 8 paid holidays
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.
Sr. Quality Assurance Specialist
The Sr. QA Specialist is responsible for managing and documenting events / discrepancies associated with either product or process as well as managing / writing any investigations that may be a result of those events; processing and investigating customer/ consumer product complaints; preparing annual product reviews; tracking, trending and follow-up of the CAPA programs.
Position Summary
This position is 100% on-site at the St. Petersburg site.
St. Petersburg is our primary Softgel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.
This position will participate in the internal audit program, customer audits and may assist with Supplier Audits/Certification Programs.
The Role
- Assist in organizing and prioritizing the activities and schedule for the QA Specialists.
- Provides feedback to QA Supervisor and Manager on performance of QA Specialists.
- Responsible for actively identifying compliance enhancements/improvements and leading project to deliver solutions.
- Collaborates with management and supervisory personnel from operations, quality control and quality assurance to resolve problems affecting product quality; collaboration includes rating, investigating and following up with operators for non-conformance issues and working jointly towards resolution.
- Provide guidance and plan of action to the manufacturing floor when production events occur as defined by SOP and lead cross functional team to classify events and deviations of non-compliant issues according to procedures as defined by SOPs.
- Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
- Prepare annual product reports and ensure on time closure. Author/compile monthly, quarterly and annual summaries and metrics, including DRB (Deviation Review Board) presentation.
- Other duties as assigned.
The Candidate
- Bachelor’s Degree in science or Engineering required (Chemistry, Microbiology or Biology preferred) and a minimum of 3 years of related experience in QA pharmaceutical manufacturing and/or manufacturing pharmaceutical operation.
- Prior experience working with investigation writing, including root cause analysis and report writing a must.
- Prior experience with preparing annual product reviews preferred.
- Proficient to advance skills in Microsoft Office applications (Word, Excel, PowerPoint and Access). Working knowledge of cGMPs and/or OSHA regulations.
- Ability to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance. Be accessible to manufacturing floor and office staff and to use required office equipment. Vision requirements include to have 20/30 vision with or without corrective lenses, read written documents and frequent use of a computer monitor.
Why You Should Work At Catalent
- Spearhead exciting and innovative projects
- Fast-paced, dynamic environment
- High visibility to members at all levels of the organization
- 152 hours of PTO + 8 paid holidays
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.
See all 110+ STEM OPT QA Specialist Jobs
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Get Access To All JobsTips for Finding STEM OPT Authorization as a QA Specialist
Verify your CIP code covers QA
Check that your degree's Classification of Instructional Programs code maps to a STEM-designated field before applying. Computer science, industrial engineering, and systems engineering CIP codes all support QA Specialist roles, but general business degrees typically don't qualify.
Confirm E-Verify status before applying
Ask every recruiter whether the company is enrolled in E-Verify before your first interview. A QA role at a company that isn't enrolled cannot support your STEM OPT extension, no matter how well the job matches your degree.
Tie your I-983 duties to your STEM field
Your training plan must connect specific QA tasks, such as defect analysis, test automation, or statistical process control, to concepts from your STEM degree. Vague descriptions like 'quality assurance support' are the leading reason DSOs flag I-983 plans for revision.
Target employers with active DOL LCA filings
Use Migrate Mate to filter QA Specialist roles by employers who have filed Labor Condition Applications, which signals active experience hiring workers on visa-based authorization and familiarity with the E-Verify enrollment requirement.
Address cap-gap timing in your offer negotiation
If your OPT expires before October 1 and your employer files an H-1B visa petition on your behalf, cap-gap protection extends your work authorization automatically. Confirm your start date and petition timeline with your employer's HR team before signing.
Use OFLC Wage Search to benchmark your offer
Look up the prevailing wage for QA Specialist roles in your target metro area using OFLC Wage Search before evaluating any offer. Employers filing an LCA must pay at least the prevailing wage, so knowing the Level I and Level II figures tells you whether an offer is compliant.
Frequently Asked Questions
Does my STEM degree qualify me for the 24-month STEM OPT extension as a QA Specialist?
It depends on your specific degree, not the job title. Your degree must appear on the USCIS STEM Designated Degree Program List and carry a qualifying CIP code. Degrees in computer science, industrial engineering, electrical engineering, and statistics commonly support QA Specialist roles. A general management or communications degree won't qualify even if your job involves quality systems work. Confirm your CIP code with your DSO before applying for the extension.
Is E-Verify enrollment required for my QA Specialist employer to support my STEM OPT?
Yes. E-Verify enrollment is a hard requirement for any employer sponsoring a STEM OPT extension, regardless of company size or industry. Before accepting a QA Specialist offer, ask HR to confirm the company's E-Verify Company ID. If the employer isn't enrolled, they must complete enrollment before you can file the extension. You can search for roles at verified employers on Migrate Mate, which filters listings by employers with relevant filing history.
What should my I-983 training plan include for a QA Specialist role?
Your I-983 must describe how the specific QA duties in your role apply knowledge from your STEM degree. Generic job descriptions aren't enough. Include concrete learning objectives tied to your major, such as applying statistical methods to defect rate analysis, using software testing frameworks tied to your computer science coursework, or implementing process controls grounded in industrial engineering principles. Your DSO and employer both sign the plan, and USCIS can audit it, so specificity matters.
Can I switch QA Specialist employers while on STEM OPT?
Yes, but you must follow the correct process. Your new employer must also be enrolled in E-Verify, the role must still relate to your STEM degree, and you must file an updated I-983 training plan with your DSO before your start date. Your DSO will issue a new I-20 reflecting the change. Working for a non-E-Verify employer, even briefly, is a violation that can affect your status and future visa eligibility.
How does cap-gap work if my employer sponsors my H-1B during my QA Specialist STEM OPT?
If your STEM OPT is still valid on April 1 and your employer files a timely H-1B petition on your behalf, cap-gap automatically extends your work authorization through September 30. If your petition is selected in the lottery and approved, your H-1B status begins October 1. If it isn't selected, your authorization ends September 30. You can continue working as a QA Specialist throughout the cap-gap period as long as your employer filed before your EAD expired.