Quality Control Specialist Visa Sponsorship Jobs in California
Quality control specialist roles in California span semiconductors and medical devices in Silicon Valley, aerospace manufacturing in Los Angeles and San Diego, and food and beverage production in the Central Valley. Major employers including Thermo Fisher Scientific, Intel, and Genentech have active sponsorship histories, making California one of the more active states for QC sponsorship.
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Get Access To All JobsAbout Codera
Codera is a Tang Capital company that provides in-house end-to-end drug development for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.
Position Summary
The Manager, Records Management (TMF Quality Control Specialist) will provide support for TMF activities by ensuring documents uploaded to the TMF adhere to Standard Operating Procedures, ICH GCP guidelines and other regulatory requirements. The Manager will act as a TMF Subject Matter Expert (SME) and work with the study teams to ensure the TMFs and CTMS for clinical studies are inspection ready at all times.
Primary Responsibilities
- Review study documents received from the study teams for completeness and accuracy and upload to the Trial Master File (TMF)
- Perform quality control of documents submitted to the TMF per SOPs, Work Instructions and Guidance Documents.
- Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed.
- Perform TMF quality reviews to ensure completeness, accuracy and timeliness of study documents to ensure TMFs are inspection ready at all times.
- Provide feedback, support and training to study teams to build knowledge and awareness of good, quality documentation management practices for clinical trials.
- Conduct TMF educational workshops/training, as needed.
- Address TMF questions pertaining to how documents are filed, and user questions related to the TMF system.
- Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis.
- Perform the secondary review of site Essential Document Packages per applicable SOPs to ensure sites meet the requirements for site activation and Investigational Product (IP) release.
- Responsible for Clinical Trial Management System (CTMS) maintenance, including study, country and site level updates and reviewing CTMS entries for accuracy.
- Contribute to TMF QC Tools as needed to match with evolving business processes (incl. QC Tool, QC Manual, Doc Owner Manual, TMF Newsletters).
- Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory considerations as applicable to the job duties.
- Assist with inspection/audit related activities (e.g., preparation, corrective action plans).
- Execute other duties as assigned.
Qualifications
- Minimum 2 years of relevant clinical research and TMF experience required
- Understanding of the clinical trial process, experience in handling clinical trial related documents required
- Previous experience in electronic TMFs, Veeva preferred
- Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management
- Must be self-motivated, well-organized, detail-oriented, and have excellent written and verbal communication skills
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment
- Strong organization skills with outstanding attention to detail and follow-through
- Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities
- Demonstrated proactive approaches to problem-solving with strong decision-making capabilities
- Must be fully proficient in MS Office Suite and internet research
The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice.
The estimated annual base salary for this position is $115,000 - $145,000, commensurate with experience and skills.
Codera provides a comprehensive benefits package designed to support employees’ physical, mental and financial health and includes employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off; retirement plan options and additional wellness and professional development programs.
Codera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Codera participates in E‑Verify. All newly hired employees are required to complete the E‑Verify process as part of their employment eligibility verification.
About Codera
Codera is a Tang Capital company that provides in-house end-to-end drug development for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products.
Position Summary
The Manager, Records Management (TMF Quality Control Specialist) will provide support for TMF activities by ensuring documents uploaded to the TMF adhere to Standard Operating Procedures, ICH GCP guidelines and other regulatory requirements. The Manager will act as a TMF Subject Matter Expert (SME) and work with the study teams to ensure the TMFs and CTMS for clinical studies are inspection ready at all times.
Primary Responsibilities
- Review study documents received from the study teams for completeness and accuracy and upload to the Trial Master File (TMF)
- Perform quality control of documents submitted to the TMF per SOPs, Work Instructions and Guidance Documents.
- Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed.
- Perform TMF quality reviews to ensure completeness, accuracy and timeliness of study documents to ensure TMFs are inspection ready at all times.
- Provide feedback, support and training to study teams to build knowledge and awareness of good, quality documentation management practices for clinical trials.
- Conduct TMF educational workshops/training, as needed.
- Address TMF questions pertaining to how documents are filed, and user questions related to the TMF system.
- Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis.
- Perform the secondary review of site Essential Document Packages per applicable SOPs to ensure sites meet the requirements for site activation and Investigational Product (IP) release.
- Responsible for Clinical Trial Management System (CTMS) maintenance, including study, country and site level updates and reviewing CTMS entries for accuracy.
- Contribute to TMF QC Tools as needed to match with evolving business processes (incl. QC Tool, QC Manual, Doc Owner Manual, TMF Newsletters).
- Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory considerations as applicable to the job duties.
- Assist with inspection/audit related activities (e.g., preparation, corrective action plans).
- Execute other duties as assigned.
Qualifications
- Minimum 2 years of relevant clinical research and TMF experience required
- Understanding of the clinical trial process, experience in handling clinical trial related documents required
- Previous experience in electronic TMFs, Veeva preferred
- Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management
- Must be self-motivated, well-organized, detail-oriented, and have excellent written and verbal communication skills
- Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment
- Strong organization skills with outstanding attention to detail and follow-through
- Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities
- Demonstrated proactive approaches to problem-solving with strong decision-making capabilities
- Must be fully proficient in MS Office Suite and internet research
The job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required. They may change, or new ones may be assigned at any time with or without notice.
The estimated annual base salary for this position is $115,000 - $145,000, commensurate with experience and skills.
Codera provides a comprehensive benefits package designed to support employees’ physical, mental and financial health and includes employer sponsored insurance plans including medical, dental and vision coverage; generous paid time off; retirement plan options and additional wellness and professional development programs.
Codera provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Codera participates in E‑Verify. All newly hired employees are required to complete the E‑Verify process as part of their employment eligibility verification.
Quality Control Specialist Job Roles in California
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Search Quality Control Specialist Jobs in CaliforniaQuality Control Specialist Jobs in California: Frequently Asked Questions
Which companies sponsor visas for quality control specialists in California?
Companies with documented H-1B visa sponsorship histories for quality control specialists in California include Thermo Fisher Scientific, Genentech, Intel, Applied Materials, and Boston Scientific. Medical device manufacturers concentrated in the Bay Area and San Diego, along with aerospace contractors in Southern California such as Northrop Grumman and Raytheon, regularly file Labor Condition Applications for QC and quality assurance roles.
Which visa types are most common for quality control specialist roles in California?
The H-1B is the most common visa for quality control specialists in California, provided the role requires at least a bachelor's degree in a directly related field such as chemistry, engineering, or materials science. Some life sciences QC positions also see L-1B transfers for candidates moving within a multinational company. TN visa status is available to Canadian and Mexican nationals whose QC role falls under a qualifying USMCA occupation category.
Which cities in California have the most quality control specialist sponsorship jobs?
San Jose and the broader Bay Area lead for semiconductor and biotech QC roles, driven by companies like Intel and Genentech. San Diego is a strong hub for pharmaceutical and medical device quality positions. Los Angeles and Long Beach are active for aerospace and defense QC. Fresno and Modesto also see QC openings in food processing and agricultural supply chains.
How to find quality control specialist visa sponsorship jobs in California?
Migrate Mate aggregates quality control specialist roles in California that are open to visa sponsorship, filtering out positions where sponsorship is not on offer. You can search by city or industry to narrow results to sectors like life sciences, semiconductors, or aerospace. Migrate Mate also surfaces employer sponsorship history, which helps you prioritize companies that have successfully sponsored QC specialists in the past.
Are there state-specific considerations for quality control specialists seeking sponsorship in California?
California's prevailing wage requirements under both state and federal rules mean employers sponsoring H-1B workers for QC roles must meet Department of Labor wage levels, which are benchmarked to California's generally higher cost of living. The state's concentration of FDA-regulated industries means many QC roles require familiarity with GMP and ISO standards, which can strengthen a sponsorship case by demonstrating specialized qualifications beyond a generalist background.
What is the prevailing wage for sponsored quality control specialist jobs in California?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.