Biosero Visa Sponsorship USA
Biosero is a laboratory automation and software company that has sponsored H-1B visas for technical roles in the U.S. For international candidates in life sciences technology, it represents a legitimate sponsorship pathway, particularly for those on F-1 OPT or TN status looking to transition to long-term work authorization.
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Get Access To All JobsAbout the role:
The Quality Assurance (QA) Specialist is responsible for supporting quality planning and ensuring compliance across production and operational processes within a regulated environment. This role works closely with manufacturing, engineering, and cross-functional teams to establish and maintain quality systems that meet applicable regulatory standards such as ISO 9001, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
The QA Specialist oversees quality processes throughout the product lifecycle, including reviewing and approving validation and quality documentation, managing deviations, CAPAs, and change controls, and ensuring that production activities meet defined quality standards. The role also supports internal and external audits, participates in vendor qualification activities, and helps maintain compliance with regulatory and industry requirements.
In addition, the position contributes to continuous improvement initiatives by monitoring quality metrics, supporting LEAN initiatives, and providing guidance and training on quality processes and compliance. The ideal candidate is detail-oriented, collaborative, and experienced in quality assurance within regulated manufacturing or life sciences environments, with a strong ability to ensure quality is built into planning, production, and operational workflows.
Key Responsibilities:
- Ensure compliance with applicable standards and regulations (ISO 9001, GAMP 5, EU GMP Annex 11, 21 CFR Part 11).
- Review and approve validation documentation (e.g., URS, FRS, test protocols, test scripts).
- Conduct and support internal and external audits, including regulatory inspections.
- Develop, implement, and maintain QA policies, procedures, and SOPs.
- Perform risk assessments and support risk-based decision-making.
- Monitor and report on quality metrics and KPIs.
- Provide training and guidance on quality and compliance topics to cross-functional teams.
- Manage deviations, CAPAs, change controls, and other quality records.
- Participate in vendor qualification and software supplier audits.
- Stay current with regulatory developments and industry best practices.
- Support the LEAN work in the company.
Requirements
- Minimum 5 years of experience in QA within a regulated software development environment.
- Experience working with LEAN.
- Strong knowledge of ISO 9001, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
- Experience with validation of computerized systems and software quality assurance.
- Excellent understanding of SDLC and software testing methodologies.
- Strong analytical, problem-solving, and communication skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Fluent in English (written and spoken); additional languages are a plus.
Educational Requirements:
- Bachelor’s or master’s degree in Life Sciences, Computer Science, Engineering, or related field.
- Experience in lieu of degree will be considered, preferably with some knowledge of lab automation and scheduling software.
Training, Skills, Knowledge, and Qualifications:
- Experience with electronic quality management systems (eQMS).
- Familiarity with Agile and DevOps environments.
- Certification in Quality Assurance or Regulatory Affairs (e.g., ASQ, RAPS) is a plus.
- Experience in pharmaceutical, biotech, or medical device industries.
Compensation and Benefits:
The base salary range for this position is $100,000-120,000 for San Diego, CA. Benefits include 401K with company match, Flexible Vacation Policy, Health Benefits, Investment in Professional and Personal Development, and much more.
Biosero provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. In addition, Biosero complies with applicable state and local laws governing nondiscrimination in employment in every location in which it has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Biosero is committed to diversity and inclusion. We seek individuals from all backgrounds and appreciate and celebrate the diversity of our growing team.
About the role:
The Quality Assurance (QA) Specialist is responsible for supporting quality planning and ensuring compliance across production and operational processes within a regulated environment. This role works closely with manufacturing, engineering, and cross-functional teams to establish and maintain quality systems that meet applicable regulatory standards such as ISO 9001, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
The QA Specialist oversees quality processes throughout the product lifecycle, including reviewing and approving validation and quality documentation, managing deviations, CAPAs, and change controls, and ensuring that production activities meet defined quality standards. The role also supports internal and external audits, participates in vendor qualification activities, and helps maintain compliance with regulatory and industry requirements.
In addition, the position contributes to continuous improvement initiatives by monitoring quality metrics, supporting LEAN initiatives, and providing guidance and training on quality processes and compliance. The ideal candidate is detail-oriented, collaborative, and experienced in quality assurance within regulated manufacturing or life sciences environments, with a strong ability to ensure quality is built into planning, production, and operational workflows.
Key Responsibilities:
- Ensure compliance with applicable standards and regulations (ISO 9001, GAMP 5, EU GMP Annex 11, 21 CFR Part 11).
- Review and approve validation documentation (e.g., URS, FRS, test protocols, test scripts).
- Conduct and support internal and external audits, including regulatory inspections.
- Develop, implement, and maintain QA policies, procedures, and SOPs.
- Perform risk assessments and support risk-based decision-making.
- Monitor and report on quality metrics and KPIs.
- Provide training and guidance on quality and compliance topics to cross-functional teams.
- Manage deviations, CAPAs, change controls, and other quality records.
- Participate in vendor qualification and software supplier audits.
- Stay current with regulatory developments and industry best practices.
- Support the LEAN work in the company.
Requirements
- Minimum 5 years of experience in QA within a regulated software development environment.
- Experience working with LEAN.
- Strong knowledge of ISO 9001, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
- Experience with validation of computerized systems and software quality assurance.
- Excellent understanding of SDLC and software testing methodologies.
- Strong analytical, problem-solving, and communication skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Fluent in English (written and spoken); additional languages are a plus.
Educational Requirements:
- Bachelor’s or master’s degree in Life Sciences, Computer Science, Engineering, or related field.
- Experience in lieu of degree will be considered, preferably with some knowledge of lab automation and scheduling software.
Training, Skills, Knowledge, and Qualifications:
- Experience with electronic quality management systems (eQMS).
- Familiarity with Agile and DevOps environments.
- Certification in Quality Assurance or Regulatory Affairs (e.g., ASQ, RAPS) is a plus.
- Experience in pharmaceutical, biotech, or medical device industries.
Compensation and Benefits:
The base salary range for this position is $100,000-120,000 for San Diego, CA. Benefits include 401K with company match, Flexible Vacation Policy, Health Benefits, Investment in Professional and Personal Development, and much more.
Biosero provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws. In addition, Biosero complies with applicable state and local laws governing nondiscrimination in employment in every location in which it has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Biosero is committed to diversity and inclusion. We seek individuals from all backgrounds and appreciate and celebrate the diversity of our growing team.
Job Roles at Biosero Companies
How to Get Visa Sponsorship in Biosero Visa Sponsorship USA
Target technical and engineering roles first
Biosero's sponsorship activity centers on its core technology and software functions. Focus your application on roles in software development, automation engineering, or systems integration, where the specialty occupation requirement for H-1B sponsorship is most straightforward to satisfy.
Understand Biosero's niche before applying
Biosero operates in laboratory automation software, a specialized intersection of biotech and tech. Candidates who can articulate how their skills directly support that niche, rather than applying generically, are better positioned for sponsorship consideration at a focused company like this.
Apply early relative to the H-1B lottery deadline
For roles targeting H-1B sponsorship, timing matters. Biosero needs time to evaluate candidates and prepare petitions before the March registration window. Reaching out or applying in the fall or early winter gives the hiring team adequate runway to move forward.
Use Migrate Mate to identify open roles with verified sponsorship history
Biosero has an active sponsorship track record across multiple visa types. Migrate Mate surfaces verified sponsors so you can filter by real sponsorship history and find Biosero openings that match your background without wading through companies that don't sponsor.
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Get Access To All JobsFrequently Asked Questions
Does Biosero sponsor H-1B visas?
Yes, Biosero sponsors H-1B visas. The company has an established track record of supporting work visa sponsorship for skilled professionals in its technology and software operations. Sponsorship is most common for technical roles that clearly meet the specialty occupation standard, such as software engineering and automation development positions.
Which visa types does Biosero sponsor?
Biosero sponsors H-1B, F-1 OPT, F-1 CPT, and TN visas. This range makes it accessible to a broad group of international candidates, including recent graduates on OPT, Canadian and Mexican nationals eligible for TN status, and experienced professionals seeking H-1B sponsorship for long-term U.S. employment.
Which departments or roles at Biosero are most likely to receive visa sponsorship?
Sponsorship at Biosero is concentrated in technical functions aligned with its core business in laboratory automation software. Roles in software development, systems engineering, and automation integration are the most likely candidates. These positions typically satisfy the specialty occupation criteria that H-1B sponsorship requires, making them the strongest targets for international applicants.
What is the typical application and sponsorship timeline at Biosero?
If you're targeting H-1B sponsorship, the process is tied to the annual USCIS registration window in March. Biosero would need to register your petition, have it selected in the lottery, and then file the full petition before the October 1 start date. Practically, this means initiating conversations with the hiring team several months before the March deadline to allow enough preparation time.
How do I find and apply to visa-sponsoring roles at Biosero?
The most efficient approach is to search for Biosero on Migrate Mate, which aggregates job listings from verified sponsoring employers and lets you filter by visa type and company. This removes the guesswork of identifying whether an employer will sponsor and puts Biosero's open roles alongside their actual sponsorship history in one place.
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