This role is fully remote in the United States. At Johnson & Johnson, we believe health is ... FDA, ISO 14155, MDR Independent thinking and planning ability Medical Device experience is ...
This role is fully remote in the United States. At Johnson & Johnson, we believe health is ... FDA, ISO 14155, MDR Independent thinking and planning ability Medical Device experience is ...
This role is fully remote in the United States. At Johnson & Johnson, we believe health is ... FDA, ISO 14155, MDR Independent thinking and planning ability Medical Device experience is ...
This role is fully remote in the United States. At Johnson & Johnson, we believe health is ... FDA, ISO 14155, MDR Independent thinking and planning ability Medical Device experience is ...
... and auditors, facilitating remote review of study records and electronic source documentation. * Ensure adherence to FDA regulations, ICH-GCP guidelines, institutional policies, and sponsor ...
... and auditors, facilitating remote review of study records and electronic source documentation. * Ensure adherence to FDA regulations, ICH-GCP guidelines, institutional policies, and sponsor ...
... and auditors, facilitating remote review of study records and electronic source documentation. * Ensure adherence to FDA regulations, ICH-GCP guidelines, institutional policies, and sponsor ...
... and auditors, facilitating remote review of study records and electronic source documentation. * Ensure adherence to FDA regulations, ICH-GCP guidelines, institutional policies, and sponsor ...
... and auditors, facilitating remote review of study records and electronic source documentation. * Ensure adherence to FDA regulations, ICH-GCP guidelines, institutional policies, and sponsor ...
... and auditors, facilitating remote review of study records and electronic source documentation. * Ensure adherence to FDA regulations, ICH-GCP guidelines, institutional policies, and sponsor ...
Sr. Quality Assurance Engineer (ISO 13485)
Irvine, CA · On-site +1
$99K - $120K/yr
Ensure compliance with applicable regulatory standards, including FDA 21 CFR Part 820, ISO 13485 ... Remote or hybrid arrangements are not available. Employment Type: full-time
Sr. Quality Assurance Engineer (ISO 13485)
Irvine, CA · On-site +1
$99K - $120K/yr
Ensure compliance with applicable regulatory standards, including FDA 21 CFR Part 820, ISO 13485 ... Remote or hybrid arrangements are not available. Employment Type: full-time
Document Control Specialist
Irvine, CA · On-site +1
$23 - $25/hr
Assists in Food and Drug Administration (FDA) inspections and Notified Body audits regarding ... Ensures accurate and timely input of database entries; implements a self-auditing system to verify ...
Document Control Specialist
Irvine, CA · On-site +1
$23 - $25/hr
Assists in Food and Drug Administration (FDA) inspections and Notified Body audits regarding ... Ensures accurate and timely input of database entries; implements a self-auditing system to verify ...
... auditor/inspector * Escalates site issues and collaborates with the study team and site staff to ... Strong understanding of ICH GCP and knowledge of FDA regulatory requirements related to clinical ...
... auditor/inspector * Escalates site issues and collaborates with the study team and site staff to ... Strong understanding of ICH GCP and knowledge of FDA regulatory requirements related to clinical ...
Director, Quality Assurance - Technical
San Diego, CA · On-site +1
San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the ... Vendor qualification and auditing * Contractor qualification * Collaborate closely with the ...
Director, Quality Assurance - Technical
San Diego, CA · On-site +1
San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the ... Vendor qualification and auditing * Contractor qualification * Collaborate closely with the ...
Remote Fda Auditor information
What is a remote FDA auditor?
Remote FDA Auditors are professionals who conduct audits and inspections of facilities, processes, and documentation to ensure compliance with the U.S. Food and Drug Administration (FDA) regulations, but they do so virtually rather than on site. Using digital tools and secure platforms, they review records, interview staff, and assess procedures from a remote location. This approach increases flexibility and efficiency while maintaining the integrity of compliance checks. Remote FDA Auditors are especially vital for organizations in the pharmaceutical, biotech, food, and medical device industries that must adhere to FDA standards.
What are the key skills and qualifications needed to thrive as a remote FDA auditor?
To thrive as a Remote FDA Auditor, you need a deep understanding of FDA regulations, auditing procedures, and quality management systems, typically supported by a degree in life sciences or a related field. Familiarity with electronic audit management tools, documentation systems, and relevant certifications such as Certified Quality Auditor (CQA) are highly valuable. Strong attention to detail, analytical thinking, and effective virtual communication are crucial soft skills for this role. These competencies ensure accurate compliance assessments, clear reporting, and effective collaboration while working remotely.
What are some common challenges faced by remote FDA auditors, and how can they be managed effectively?
Remote FDA Auditors often encounter challenges such as limited access to physical documents, time zone differences with global clients, and ensuring secure communication. To manage these effectively, auditors should familiarize themselves with digital audit tools, establish clear communication protocols with clients, and stay updated on remote auditing best practices. Proactive planning and strong organizational skills are essential for success in this role.
What is the difference between Remote Fda Auditor vs Remote Quality Assurance Specialist?
| Aspect | Remote Fda Auditor | Remote Quality Assurance Specialist |
|---|---|---|
| Certifications | FDA auditor certification, GxP, GMP, GLP | ISO, Six Sigma, GMP, GCP |
| Work Environment | Regulatory agencies, pharmaceutical, biotech companies | Manufacturing, clinical trials, healthcare companies |
| Industry Usage | Primarily in pharma, biotech, medical devices | Broader across healthcare, manufacturing, biotech |
The Remote Fda Auditor focuses on ensuring compliance with FDA regulations through audits of facilities and processes, mainly in pharma and biotech industries. The Remote Quality Assurance Specialist oversees quality systems, policies, and procedures across various healthcare sectors. While both roles require knowledge of GMP and regulatory standards, the Fda Auditor emphasizes compliance verification, whereas the QA Specialist concentrates on maintaining quality standards throughout the organization.
How do you become a remote FDA auditor?
To become a remote FDA auditor, candidates typically need a background in life sciences, healthcare, or quality assurance, along with experience in regulatory compliance. Earning certifications such as RAC or ISO auditor training can enhance prospects, and strong knowledge of FDA regulations and audit procedures is essential. Many roles require prior industry experience and familiarity with remote auditing tools and documentation practices.
What are the most commonly searched types of Fda Auditor jobs in California?
The most popular types of Fda Auditor jobs in California are:
What are popular job titles related to Remote Fda Auditor jobs in California?
For Remote Fda Auditor jobs in California, the most frequently searched job titles are:
What job categories do people searching Remote Fda Auditor jobs in California look for?
The top searched job categories for Remote Fda Auditor jobs in California are:
- Remote Quality Assurance Manager
- Remote Quality Assurance Internal Auditor
- Remote Asq Cqa
- Senior Food Safety Quality Assurance Manager
- Remote Website Auditor
- Day Shift Iatf 16949 Lead Auditor
- Audit Assurance
- Day Shift Remote Pharmaceutical Quality Assurance
- Director Of Quality And Compliance
- Sr Quality Auditor
What cities in California are hiring for Remote Fda Auditor jobs?
Cities in California with the most Remote Fda Auditor job openings:
Full-time
Retirement, PTO
Posted 12 days ago
Johnson & Johnson rating
8.3
Based on 112 frontline employees who took The Breakroom Quiz
25th of 86 rated pharmaceutical
Job description
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Santa Clara, California, United States of AmericaJob Description:
Johnson & Johnson is hiring for a Sr. Clinical Quality Auditor- Shockwave Medical to join our team. This role is fully remote in the United States.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Position Overview
The Sr. Clinical Quality Auditor will provide GCP and compliance-related audits of internal and external Clinical Studies in process, support updates of procedures in compliance with applicable regulations and perform vendor audits as needed. This work is accomplished with moderate oversight, requires frequent contact with internal and external customers and is critical to the success of the business.
Essential Job Functions
- Act as a Clinical Quality Auditor Lead on clinical trials by supporting project team compliance with national and international regulatory standards and guidance for medical devices
- Support development of audit management plans and audit strategy for ongoing clinical trials
- Conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines and in alignment with internal audit plans
- Participate in the development of departmental standard operating procedures, work instructions, forms, and templates
- Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented
- Support or conduct training for staff (GCP, Inspection Readiness training, etc.)
- Support regulatory inspections
- Review/revise Standard Operating Procedure (SOPs) and procedures as assigned
- Responsible for initial and ongoing audit of clinical study vendors such as CRO, imaging core lab, central laboratory and other vendors as needed
- Identifies and escalates site, vendor and study related issues to management, as appropriate
- This work is accomplished with moderate supervision and requires a motivated, self-starter who can work independently once projects are assigned
Requirements
Bachelor's Degree or equivalent experience in a scientific field of study
5 years' experience directly supporting clinical research, QA, or relevant experience in medical/scientific area.
Experience conducting audits of vendors and investigative sites
Experience interacting with regulatory authority inspectors
Experience preparing and supporting clinical study sites undergoing regulatory authority inspections
Experience revising SOPs and procedures
Thorough knowledge and application of Good Clinical Practice (GCP) is required, i.e. FDA, ISO 14155, MDR
Independent thinking and planning ability
Medical Device experience is preferred
Excellent written and verbal communication skills
Exceptional teamwork skills
Requires a motivated, self-starter who can work independently once projects are assigned.
Basic understanding of peripheral and coronary artery disease and therapies preferred
Knowledge and experience in supporting device pre- and/or post-market clinical studies is required
ACRP or SOCRA certification preferred
Ability to work in a fast-paced environment while managing multiple priorities across multiple projects
Operate as a team and/or independently while demonstrating flexibility to changing requirements
Must have excellent verbal and written communication skills
High attention to detail and accuracy
Ability to travel up to 30%-40%of time domestically and internationally
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality StandardsThe anticipated base pay range for this position is :
$91,000.00 - $147,200.00Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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