H-1B Visa Quality Specialist Jobs
Quality Specialist roles qualify for H-1B visa sponsorship when the position requires a bachelor's degree or higher in a directly related field such as engineering, chemistry, or quality management. Employers file an LCA with DOL before petitioning USCIS, certifying the role meets prevailing wage standards for your work location.
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Get Access To All JobsINTRODUCTION
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
ROLE AND RESPONSIBILITIES
The QC Specialist is responsible for coordinating and completing assigned QC reviews, ensuring that clinical and regulatory documents undergo review, copyediting, data verification, and proofreading in a manner that conforms to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Clinical and regulatory documents include study reports, clinical study protocols or amendments, investigator’s brochures, and the clinical sections of INDs, NDAs, MAAs, and other regulatory submission documents. Other documents may include manuscripts, abstracts, posters, briefing documents, responses to health authorities, narratives, and any other documents authored or supported by Global Medical Writing that require a QC review.
This work can be done remotely or from any of BeOne’s global offices.
Essential Functions of the Job:
Document Review and Editing:
- Works effectively within the Global Medical Writing department to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents.
- Responsible for performing a quality check of clinical and regulatory documents before approval.
- Performs cross-referencing, fact-checking, and general quality assessments of documents.
- Proofreads documents for grammatical and formatting errors, hyperlink functionality, data source verification, and proper translation of data.
- Ensures compliance with Global Medical Writing conventions, processes, templates and applicable regulatory guidelines.
- Maintains strong attention to detail (ie, to consistency, grammar, syntax, and scientific accuracy) while performing technical edits.
Project and Process Management:
- Ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality QC reviews according to tight timelines and shifting priorities/demands.
- Adheres to QC timelines and communicates with Medical Writers to maintain awareness of expectations, milestones, and deliverables.
- Contributes to team direction and strategy discussions, with guidance from managers and mentors.
Influence and Training:
- Builds effective partnerships with all intradepartmental teams when collaborating on QC reviews and projects.
- Engages in trainings that will increase knowledge of medical writing, the types of documents in the scope of the Global Medical Writing team, medical terminology, and the development of drugs and biologics.
BASIC QUALIFICATIONS
- Demonstrated ability to communicate in clear, concise, and effective English (both written and verbal).
- Experience in conducting medical writing QC reviews of pharmaceutical industry regulatory documents (such as clinical study reports, protocols, and protocol amendments) or experience in technical editing in a related or similar industry; experience in reviewing clinical sections of INDs, MAAs, and NDAs is a plus.
- Familiarity with the general process of drug/biologics development as well as the key requirements for regulatory submissions as defined in FDA regulations and ICH guidelines is preferred.
SUPERVISORY RESPONSIBILITIES
Not applicable for this role.
OTHER QUALIFICATIONS
- Effective Communication: Explains own work clearly. Able to escalate questions/issues to appropriate stakeholders at an early stage, with guidance from manager/mentor. Takes part in discussions with different viewpoints, and be able to provide value-added inputs with guidance from manager/mentor.
- Embracing Change: Always seeking and open to new opportunities and changes. Copes well with change and new challenges with guidance from manager/mentor. Contributes to specific change activities.
- Creating Innovation: Demonstrates openness to innovation and applies new ways of working (eg, skills or techniques) in own work to improve time management, timeliness, and accuracy.
- Thinking Strategically: Understands key concepts (eg, strategic review, lean writing) related to own work with guidance from manager/mentor. Demonstrates awareness of company strategies and general events happening in the industry (eg, regulations, guidelines, and trends).
- Mentoring: Provides specific feedback to others within own team as requested. Solicits feedback and accepts and integrates changes from constructive criticism. Willingly shares own knowledge and experience to support others’ learning.
COMPUTER SKILLS:
- Technical expertise in Microsoft Word, Microsoft Outlook, Excel, PowerPoint, and Adobe Acrobat.
- Proficiency in navigating Microsoft Windows.
- Familiarity with SharePoint and Veeva Vault is a plus.
TRAVEL
Not applicable.
EDUCATION REQUIRED
BA/BS degree; Masters, PhD/PharmD, or other graduate-level degree is a plus.
At least 1 year of relevant industry experience as a QC editor/specialist, medical writer, or technical copyeditor.
COMPENSATION
- Salary Range: $74,600.00 - $99,600.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
INTRODUCTION
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
ROLE AND RESPONSIBILITIES
The QC Specialist is responsible for coordinating and completing assigned QC reviews, ensuring that clinical and regulatory documents undergo review, copyediting, data verification, and proofreading in a manner that conforms to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Clinical and regulatory documents include study reports, clinical study protocols or amendments, investigator’s brochures, and the clinical sections of INDs, NDAs, MAAs, and other regulatory submission documents. Other documents may include manuscripts, abstracts, posters, briefing documents, responses to health authorities, narratives, and any other documents authored or supported by Global Medical Writing that require a QC review.
This work can be done remotely or from any of BeOne’s global offices.
Essential Functions of the Job:
Document Review and Editing:
- Works effectively within the Global Medical Writing department to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents.
- Responsible for performing a quality check of clinical and regulatory documents before approval.
- Performs cross-referencing, fact-checking, and general quality assessments of documents.
- Proofreads documents for grammatical and formatting errors, hyperlink functionality, data source verification, and proper translation of data.
- Ensures compliance with Global Medical Writing conventions, processes, templates and applicable regulatory guidelines.
- Maintains strong attention to detail (ie, to consistency, grammar, syntax, and scientific accuracy) while performing technical edits.
Project and Process Management:
- Ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality QC reviews according to tight timelines and shifting priorities/demands.
- Adheres to QC timelines and communicates with Medical Writers to maintain awareness of expectations, milestones, and deliverables.
- Contributes to team direction and strategy discussions, with guidance from managers and mentors.
Influence and Training:
- Builds effective partnerships with all intradepartmental teams when collaborating on QC reviews and projects.
- Engages in trainings that will increase knowledge of medical writing, the types of documents in the scope of the Global Medical Writing team, medical terminology, and the development of drugs and biologics.
BASIC QUALIFICATIONS
- Demonstrated ability to communicate in clear, concise, and effective English (both written and verbal).
- Experience in conducting medical writing QC reviews of pharmaceutical industry regulatory documents (such as clinical study reports, protocols, and protocol amendments) or experience in technical editing in a related or similar industry; experience in reviewing clinical sections of INDs, MAAs, and NDAs is a plus.
- Familiarity with the general process of drug/biologics development as well as the key requirements for regulatory submissions as defined in FDA regulations and ICH guidelines is preferred.
SUPERVISORY RESPONSIBILITIES
Not applicable for this role.
OTHER QUALIFICATIONS
- Effective Communication: Explains own work clearly. Able to escalate questions/issues to appropriate stakeholders at an early stage, with guidance from manager/mentor. Takes part in discussions with different viewpoints, and be able to provide value-added inputs with guidance from manager/mentor.
- Embracing Change: Always seeking and open to new opportunities and changes. Copes well with change and new challenges with guidance from manager/mentor. Contributes to specific change activities.
- Creating Innovation: Demonstrates openness to innovation and applies new ways of working (eg, skills or techniques) in own work to improve time management, timeliness, and accuracy.
- Thinking Strategically: Understands key concepts (eg, strategic review, lean writing) related to own work with guidance from manager/mentor. Demonstrates awareness of company strategies and general events happening in the industry (eg, regulations, guidelines, and trends).
- Mentoring: Provides specific feedback to others within own team as requested. Solicits feedback and accepts and integrates changes from constructive criticism. Willingly shares own knowledge and experience to support others’ learning.
COMPUTER SKILLS:
- Technical expertise in Microsoft Word, Microsoft Outlook, Excel, PowerPoint, and Adobe Acrobat.
- Proficiency in navigating Microsoft Windows.
- Familiarity with SharePoint and Veeva Vault is a plus.
TRAVEL
Not applicable.
EDUCATION REQUIRED
BA/BS degree; Masters, PhD/PharmD, or other graduate-level degree is a plus.
At least 1 year of relevant industry experience as a QC editor/specialist, medical writer, or technical copyeditor.
COMPENSATION
- Salary Range: $74,600.00 - $99,600.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
See all 441+ H-1B Visa Quality Specialist Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Quality Specialist
Map your degree to the SOC code
USCIS scrutinizes whether your degree field directly supports a Quality Specialist role. Pull the O*NET profile for your target SOC code and confirm the listed education requirements match your transcript before applying.
Target manufacturers enrolled in E-Verify
Manufacturers and regulated industries like medical devices, aerospace, and pharmaceuticals file H-1B petitions most consistently for quality roles. E-Verify enrollment signals an employer already has infrastructure for work-authorization compliance.
Check prevailing wage before negotiating offers
Your employer's LCA must certify a wage at or above the DOL prevailing wage for your job title and location. Run the OFLC Wage Search for your specific SOC code before any offer conversation so you know the floor.
Use Migrate Mate to filter verified sponsors
Search Quality Specialist roles on Migrate Mate to see which employers have active H-1B LCA filing history for this occupation, so you're targeting companies with a documented record of sponsoring this role type.
Request premium processing before your OPT expires
Standard H-1B processing can run several months. If you're on OPT with a cap-gap window, ask your employer to file Form I-907 for premium processing so USCIS adjudicates within 15 business days and your start date isn't delayed.
Document quality certifications in your petition
ASQ certifications, ISO 9001 auditor credentials, and Six Sigma belts strengthen the specialty occupation argument in your I-129 petition. Compile official certification letters alongside your transcript to support the employer's filing.
H-1B Visa Quality Specialist: Frequently Asked Questions
Does a Quality Specialist role qualify as a specialty occupation for H-1B purposes?
It depends on how the employer defines the position. USCIS requires that the role normally demands at least a bachelor's degree in a specific field, not just any degree. A Quality Specialist tied to a regulated industry like medical devices, pharmaceuticals, or aerospace, with documented degree requirements in engineering or a science discipline, has a stronger specialty occupation argument than a generalist QA role.
Which industries sponsor H-1B visas for Quality Specialist roles most consistently?
Manufacturing sectors with federal regulatory requirements file H-1B petitions for quality roles most frequently. Medical device and pharmaceutical manufacturers must meet FDA quality system regulations, aerospace suppliers face FAA and AS9100 requirements, and automotive Tier 1 suppliers operate under IATF 16949. These compliance frameworks create ongoing demand for degreed quality professionals. You can browse employers with verified filing history on Migrate Mate.
How does the DOL prevailing wage requirement affect a Quality Specialist job offer?
Before your employer files the H-1B petition, they must submit an LCA to DOL certifying that your offered wage meets or exceeds the prevailing wage for your SOC code and work location. USCIS treats the LCA wage floor as a compliance requirement, not a suggestion. Offers that fall below the prevailing wage will cause the LCA to be rejected, blocking the entire petition.
Can my employer sponsor my H-1B if they've never done it before?
Yes. There's no requirement that an employer have prior H-1B sponsorship history. However, first-time sponsors must register for the annual H-1B lottery, file the LCA through DOL, and submit a complete I-129 petition to USCIS. The process is paperwork-intensive, and many first-time sponsors work with an immigration attorney to avoid filing errors that could delay or jeopardize the petition.
What happens to my H-1B status if I change Quality Specialist roles at a new employer?
You can transfer your H-1B to a new employer through portability under AC21, which allows you to start working for the new employer as soon as they file the transfer petition, without waiting for approval. The new employer must file a new LCA and I-129 covering the new role. If the new Quality Specialist position differs substantially in duties or location, USCIS may review whether it still qualifies under the original approval terms.