H-1B Visa Quality Assurance Auditor Jobs
Quality Assurance Auditor roles qualify for H-1B visa sponsorship as specialty occupations requiring at least a bachelor's degree in quality management, engineering, or a related field. Employers in manufacturing, pharmaceuticals, medical devices, and aerospace regularly file LCAs for these positions, making them a reliable target for H-1B candidates.
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Get Access To All JobsINTRODUCTION
Catalent’s Greenville, North Carolina site is a major oral solid dose development and manufacturing campus, delivering end‑to‑end, turnkey solutions from formulation development through commercial manufacturing and packaging. The site specializes in oral solid dosage forms, supported by integrated formulation expertise, comprehensive analytical services, and scalable manufacturing capabilities designed to support both commercial products and potent or targeted therapies, including orphan drugs. Backed by more than $100 million in recent investments, the Greenville operation features fit‑for‑scale infrastructure, potent handling capabilities, and a strong regulatory track record, making it a critical part of Catalent’s global network for advancing complex oral drug programs from development to market.
Position Summary
This Quality Assurance Auditor – Manufacturing role requires the ability to perform established routine and non-routine Quality Assurance tasks with minimal supervision in support of internal non-commercial clients, external clients and/or commercial processes and projects as assigned.
Shift: Monday- Friday 8:00am-5:00pm
Location: Greenville, NC
100% Onsite
THE ROLE
- Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities
- Provide broad advocacy for the continued improvement of quality standards and the development and maintenance of a quality culture across the organization
- Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout the facility
- Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards
- Ensure compliance to all compendial, internal and client-specific requirements (i.e. SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable)
- Perform in-process QA checks
- Assure release of raw materials and components prior to manufacturing/packaging
- Provide real-time support activities for manufacturing and packaging operations
- Review batch records
- Ensure all work is performed and documented in accordance with approved standard operating procedures, in compliance with cGMPs
- Other duties as assigned
MINIMUM REQUIREMENTS
- Bachelor’s degree with 3 years of professional experience in the pharmaceutical industry with 1 year in a direct QA role
- Associate degree with 4 years of professional experience in the pharmaceutical industry with 2 years in a direct QA role
- At least 1 year of batch record review and on the floor quality assurance manufacturing support
- Position requires the capacity to handle and manipulate objects using hands and arms
WHY YOU SHOULD JOIN CATALENT
- Positive and fast-paced working environment focusing on continual improvement and innovation.
- Competitive Paid Time Off plus 8 paid holidays.
- Medical, dental, and vision benefits effective day one of employment.
- Tuition Reimbursement to help you finish your degree or earn a new one.
- Engaging site-based activities such as Music Bingo, Puppy Supply Donation Program, and seasonal events.
- Employee Resource Groups promoting Diversity and Inclusion.
- Green initiatives and community engagement programs including highway clean-up.
- Defined career path with annual performance reviews and growth opportunities.
- WellHub program promoting physical and mental wellness, including onsite fitness center.
- Exclusive discounts through Perkspot from over 900 merchants.
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.
Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.
Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.
INTRODUCTION
Catalent’s Greenville, North Carolina site is a major oral solid dose development and manufacturing campus, delivering end‑to‑end, turnkey solutions from formulation development through commercial manufacturing and packaging. The site specializes in oral solid dosage forms, supported by integrated formulation expertise, comprehensive analytical services, and scalable manufacturing capabilities designed to support both commercial products and potent or targeted therapies, including orphan drugs. Backed by more than $100 million in recent investments, the Greenville operation features fit‑for‑scale infrastructure, potent handling capabilities, and a strong regulatory track record, making it a critical part of Catalent’s global network for advancing complex oral drug programs from development to market.
Position Summary
This Quality Assurance Auditor – Manufacturing role requires the ability to perform established routine and non-routine Quality Assurance tasks with minimal supervision in support of internal non-commercial clients, external clients and/or commercial processes and projects as assigned.
Shift: Monday- Friday 8:00am-5:00pm
Location: Greenville, NC
100% Onsite
THE ROLE
- Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities
- Provide broad advocacy for the continued improvement of quality standards and the development and maintenance of a quality culture across the organization
- Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout the facility
- Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards
- Ensure compliance to all compendial, internal and client-specific requirements (i.e. SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable)
- Perform in-process QA checks
- Assure release of raw materials and components prior to manufacturing/packaging
- Provide real-time support activities for manufacturing and packaging operations
- Review batch records
- Ensure all work is performed and documented in accordance with approved standard operating procedures, in compliance with cGMPs
- Other duties as assigned
MINIMUM REQUIREMENTS
- Bachelor’s degree with 3 years of professional experience in the pharmaceutical industry with 1 year in a direct QA role
- Associate degree with 4 years of professional experience in the pharmaceutical industry with 2 years in a direct QA role
- At least 1 year of batch record review and on the floor quality assurance manufacturing support
- Position requires the capacity to handle and manipulate objects using hands and arms
WHY YOU SHOULD JOIN CATALENT
- Positive and fast-paced working environment focusing on continual improvement and innovation.
- Competitive Paid Time Off plus 8 paid holidays.
- Medical, dental, and vision benefits effective day one of employment.
- Tuition Reimbursement to help you finish your degree or earn a new one.
- Engaging site-based activities such as Music Bingo, Puppy Supply Donation Program, and seasonal events.
- Employee Resource Groups promoting Diversity and Inclusion.
- Green initiatives and community engagement programs including highway clean-up.
- Defined career path with annual performance reviews and growth opportunities.
- WellHub program promoting physical and mental wellness, including onsite fitness center.
- Exclusive discounts through Perkspot from over 900 merchants.
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.
Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.
Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.
See all H-1B Visa Quality Assurance Auditor Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Quality Assurance Auditor
Verify your degree supports specialty occupation
H-1B approval depends on your degree field matching the QA Auditor role. A degree in industrial engineering, chemistry, or quality systems is a stronger fit than a general business degree. Check O*NET for the occupation's accepted education pathways before applying.
Target regulated industries with audit mandates
Pharmaceutical, medical device, aerospace, and food manufacturing employers file H-1B petitions for QA Auditors consistently because FDA and ISO compliance requires credentialed specialists. Focusing your search on these sectors raises your chances of finding active sponsorship.
Search verified H-1B sponsors on Migrate Mate
Filter your job search on Migrate Mate by employers with confirmed H-1B LCA filing history for QA and quality engineering roles. That data comes from DOL disclosures, so you're targeting companies with a documented record of sponsoring this occupation.
Confirm LCA wage level before accepting an offer
Your employer's LCA must certify a prevailing wage at Level I through IV. Use the OFLC Wage Search to look up the certified wage for your SOC code and work location before signing, so there are no surprises during USCIS adjudication.
Time your offer around the H-1B cap window
USCIS only accepts H-1B cap registrations in March for an October 1 start date. If you receive an offer outside that window, ask your employer whether a cap-exempt entity such as a university or nonprofit research organization is involved in the role.
Document audit certifications for the H-1B petition
Credentials like ASQ Certified Quality Auditor or ISO 9001 Lead Auditor strengthen your employer's specialty occupation argument in the I-129 petition. Gather official certificates and transcripts early, since USCIS may request these in a Request for Evidence.
H-1B Visa Quality Assurance Auditor: Frequently Asked Questions
Does a Quality Assurance Auditor role qualify as a specialty occupation for H-1B purposes?
Yes, provided the employer can show the position normally requires at least a bachelor's degree in a specific related field such as quality engineering, industrial engineering, chemistry, or life sciences. Generalist roles where any degree is accepted can face scrutiny, so the job description should explicitly tie duties to a specialized field of study.
Which industries sponsor H-1B visas most consistently for QA Auditor positions?
Pharmaceutical manufacturers, medical device companies, aerospace contractors, and food and beverage producers are among the most active H-1B sponsors for QA Auditors. These industries operate under strict regulatory frameworks from the FDA, FAA, and ISO bodies that require credentialed audit professionals, making H-1B sponsorship a practical business necessity rather than an exception.
How do I find employers actively sponsoring H-1B visas for Quality Assurance Auditor roles?
Search on Migrate Mate, which surfaces employers with verified LCA filing history for QA and quality engineering occupations using DOL disclosure data. This filters out employers who say they sponsor but have no documented filings, saving you time on applications that are unlikely to lead to a petition.
Can professional certifications like CQA or ISO Lead Auditor help my H-1B petition?
They can, but they don't substitute for a qualifying degree. USCIS evaluates specialty occupation based on the degree requirement, not certifications alone. That said, holding an ASQ Certified Quality Auditor or ISO 9001 Lead Auditor credential reinforces the argument that the role requires specialized knowledge and can help counter a Request for Evidence if your degree field is adjacent rather than directly aligned.
What happens to my H-1B status if my employer loses a major audit contract and my role changes?
A material change in job duties, location, or employer can require an amended H-1B petition. If your core QA Auditor responsibilities shift significantly, USCIS expects your employer to file an amended I-129 before the change takes effect. Failing to do so can create a period of unauthorized employment, so you should flag any substantial role changes to your employer's immigration counsel promptly.