... g., FDA, GMP) and industry best practices. Ø Collaborate with key stakeholders to ensure ... and investigations. Ø Strong analytical and problem-solving abilities. Ø Proficiency in root ...
... g., FDA, GMP) and industry best practices. Ø Collaborate with key stakeholders to ensure ... and investigations. Ø Strong analytical and problem-solving abilities. Ø Proficiency in root ...
A staffing and recruiting firm is seeking a Senior Complaint Specialist to manage medical device complaint investigations and ensure compliance with FDA regulations. The ideal candidate should have 3 ...
A staffing and recruiting firm is seeking a Senior Complaint Specialist to manage medical device complaint investigations and ensure compliance with FDA regulations. The ideal candidate should have 3 ...
Principal Investigator
Houston, TX · On-site
Adhere to study protocols, FDA regulations, and Good Clinical Practice (GCP) at all times ... Oversee Sub-Investigators and recruitment team. Education/Experience: * One to two years of ...
Quick apply
Principal Investigator
Houston, TX · On-site
Adhere to study protocols, FDA regulations, and Good Clinical Practice (GCP) at all times ... Oversee Sub-Investigators and recruitment team. Education/Experience: * One to two years of ...
To date, over 43 therapiesconductedat STARTlocationshave obtained FDA/EMA approval.Incredibly ... The Clinical Principal Investigator (PI) is a physician-scientist responsible for the overall ...
Quick apply
To date, over 43 therapiesconductedat STARTlocationshave obtained FDA/EMA approval.Incredibly ... The Clinical Principal Investigator (PI) is a physician-scientist responsible for the overall ...
Sub-Investigator, PA
Buffalo, NY · On-site
$110K - $130K/yr
Job Summary The Sub-Investigator, under the supervision of the Principal Investigator, is ... Adhere to good clinical practices and FDA human subject protection guidelines * Administer Informed ...
Sub-Investigator, PA
Buffalo, NY · On-site
$110K - $130K/yr
Job Summary The Sub-Investigator, under the supervision of the Principal Investigator, is ... Adhere to good clinical practices and FDA human subject protection guidelines * Administer Informed ...
Principal Investigator
San Bernardino, CA · On-site
Maintain compliance with FDA regulations, ICH-GCP, IRB requirements, and KCR SOPs Therapeutic Areas ... Take on expanded investigator leadership roles * Participate in study selection and site growth
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Principal Investigator
San Bernardino, CA · On-site
Maintain compliance with FDA regulations, ICH-GCP, IRB requirements, and KCR SOPs Therapeutic Areas ... Take on expanded investigator leadership roles * Participate in study selection and site growth
Sub Investigator (2745)
Brookline, MA · On-site
$60 - $75/hr
The Sub-Investigator (Part time/Contract) is accountable and responsible for ensuring adherence to ... Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs ...
New
Sub Investigator (2745)
Brookline, MA · On-site
$60 - $75/hr
The Sub-Investigator (Part time/Contract) is accountable and responsible for ensuring adherence to ... Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs ...
New
Sub Investigator (2745)
Brookline, MA · On-site
$60 - $75/hr
The Sub-Investigator (Part time/Contract) is accountable and responsible for ensuring adherence to ... Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs ...
New
Sub Investigator (2745)
Brookline, MA · On-site
$60 - $75/hr
The Sub-Investigator (Part time/Contract) is accountable and responsible for ensuring adherence to ... Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs ...
New
Sub-Investigator
Houston, TX · On-site
$52/hr
Recognizes and reports adverse events/serious adverse events to study coordinators, Principal Investigators, FDA, and sponsors * Performs study procedures, as outlined in the protocols and within ...
Sub-Investigator
Houston, TX · On-site
$52/hr
Recognizes and reports adverse events/serious adverse events to study coordinators, Principal Investigators, FDA, and sponsors * Performs study procedures, as outlined in the protocols and within ...
Execution of Form FDA 1572 for each study, and compliance with Form FDA 1572 requirements for ... Assuring that a qualified physician (PI or sub-investigator) is responsible for all trial-related ...
Execution of Form FDA 1572 for each study, and compliance with Form FDA 1572 requirements for ... Assuring that a qualified physician (PI or sub-investigator) is responsible for all trial-related ...
Execution of Form FDA 1572 for each study, and compliance with Form FDA 1572 requirements for ... Assuring that a qualified physician (PI or sub-investigator) is responsible for all trial-related ...
Execution of Form FDA 1572 for each study, and compliance with Form FDA 1572 requirements for ... Assuring that a qualified physician (PI or sub-investigator) is responsible for all trial-related ...
Part Time Principal Investigator
$120 - $150/hr
Prior experience as a PI or Sub-Investigator is required. • Strong documentation, communication, and confidentiality practices (HIPAA/PHI). • Familiarity with ICH-GCP and FDA regulations (21 CFR ...
Part Time Principal Investigator
$120 - $150/hr
Prior experience as a PI or Sub-Investigator is required. • Strong documentation, communication, and confidentiality practices (HIPAA/PHI). • Familiarity with ICH-GCP and FDA regulations (21 CFR ...
Part Time Principal Investigator
$120 - $150/hr
... FDA/21 CFR, and Arizona or Texas state requirements (as applicable). • Review clinical data (labs, ECGs, vitals) and support timely safety reporting and documentation. • Contribute to high ...
Part Time Principal Investigator
$120 - $150/hr
... FDA/21 CFR, and Arizona or Texas state requirements (as applicable). • Review clinical data (labs, ECGs, vitals) and support timely safety reporting and documentation. • Contribute to high ...
Maintain compliance with FDA regulations, ICH-GCP, IRB requirements, and KCR SOPs What We Offer ... Lead Investigator status across multiple studies * Involvement in study selection and portfolio ...
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Maintain compliance with FDA regulations, ICH-GCP, IRB requirements, and KCR SOPs What We Offer ... Lead Investigator status across multiple studies * Involvement in study selection and portfolio ...
Maintain compliance with FDA regulations, ICH-GCP, IRB requirements, and KCR SOPs What We Offer ... Investigators who demonstrate strong study performance, leadership, and alignment with KCRs mission ...
Quick apply
Maintain compliance with FDA regulations, ICH-GCP, IRB requirements, and KCR SOPs What We Offer ... Investigators who demonstrate strong study performance, leadership, and alignment with KCRs mission ...
Principal Investigator (Internal Medicine)
Woodland Hills, CA · On-site
$125 - $150/hr
Prior experience as a PI or Sub-Investigator ... Familiarity with ICH-GCP and FDA regulations (21 CFR Parts 50, 54, 56, 312, 812). * Board ...
Quick apply
Principal Investigator (Internal Medicine)
Woodland Hills, CA · On-site
$125 - $150/hr
Prior experience as a PI or Sub-Investigator ... Familiarity with ICH-GCP and FDA regulations (21 CFR Parts 50, 54, 56, 312, 812). * Board ...
Neurologist Principal Investigator
Long Beach, CA · On-site
$300K - $350K/yr
... recently FDA-approved medication in Alzheimer's Disease. Irvine Clinical Research is hiring a ... Lead study team as a Principal or Sub-Investigator, ensuring trials are conducted safely and per ...
Neurologist Principal Investigator
Long Beach, CA · On-site
$300K - $350K/yr
... recently FDA-approved medication in Alzheimer's Disease. Irvine Clinical Research is hiring a ... Lead study team as a Principal or Sub-Investigator, ensuring trials are conducted safely and per ...
Neurologist Principal Investigator
$300K - $350K/yr
... recently FDA-approved medication in Alzheimer's Disease. Irvine Clinical Research is hiring a ... Lead study team as a Principal or Sub-Investigator, ensuring trials are conducted safely and per ...
Neurologist Principal Investigator
$300K - $350K/yr
... recently FDA-approved medication in Alzheimer's Disease. Irvine Clinical Research is hiring a ... Lead study team as a Principal or Sub-Investigator, ensuring trials are conducted safely and per ...
... recently FDA-approved medication in Alzheimer's Disease. Irvine Clinical Research is hiring a ... Lead study team as a Principal or Sub-Investigator, ensuring trials are conducted safely and per ...
Quick apply
... recently FDA-approved medication in Alzheimer's Disease. Irvine Clinical Research is hiring a ... Lead study team as a Principal or Sub-Investigator, ensuring trials are conducted safely and per ...
Neurologist Principal Investigator
$300K - $350K/yr
... recently FDA-approved medication in Alzheimer's Disease. Irvine Clinical Research is hiring a ... Lead study team as a Principal or Sub-Investigator, ensuring trials are conducted safely and per ...
Neurologist Principal Investigator
$300K - $350K/yr
... recently FDA-approved medication in Alzheimer's Disease. Irvine Clinical Research is hiring a ... Lead study team as a Principal or Sub-Investigator, ensuring trials are conducted safely and per ...
Fda Investigator information
See salary details
$32K - $41K
7% of jobs
$41K - $50K
14% of jobs
$51.5K is the 25th percentile. Wages below this are outliers.
$50K - $59K
24% of jobs
The median wage is $63.5K / yr.
$59K - $68K
9% of jobs
$68K - $77K
5% of jobs
$77K - $86K
15% of jobs
$86.8K is the 75th percentile. Wages above this are outliers.
$86K - $95K
3% of jobs
$95K - $104K
6% of jobs
$104K - $113K
4% of jobs
$113K - $122K
12% of jobs
$122K - $131K
0% of jobs
$32K
$75.3K
$131K
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What do FDA auditors make?
What does an FDA Investigator do?
An FDA Investigator is responsible for inspecting facilities that manufacture, process, or distribute regulated products, including food, drugs, medical devices, and cosmetics. They ensure compliance with federal regulations, identify violations, and document findings through reports. Investigators may also collect samples, review records, and participate in enforcement actions when necessary. Their work helps protect public health by ensuring the safety, efficacy, and quality of products entering the market.
What does an FDA investigator do?
What are the key skills and qualifications needed to thrive in the Fda Investigator position, and why are they important?
To thrive as an FDA Investigator, you need a background in science or public health, strong analytical skills, and often a bachelor's degree in a related field. Familiarity with regulatory databases, laboratory sampling equipment, and federal inspection protocols is typically required. Effective communication, meticulous attention to detail, and strong organizational skills help investigators excel in documenting findings and interacting with diverse stakeholders. These attributes are crucial for ensuring compliance with federal regulations and protecting public health.
What does a typical day look like for an FDA Investigator?
A typical day for an FDA Investigator involves conducting on-site inspections of food, drug, medical device, or cosmetic manufacturers to ensure compliance with federal regulations. Investigators review production processes, collect samples, examine records, and interview facility staff to assess safety and quality standards. The role often includes significant report writing and follow-up activities to document findings and recommend corrective actions. While much of the work is independent, FDA Investigators also collaborate closely with colleagues, regulatory officials, and industry representatives to resolve issues and maintain public health standards.

Full-time
Posted 26 days ago
Job description
Essential Duties and Responsibilities:
Ø Use available resources to manage and track workload to meet required timelines.
Ø Prepare thorough investigation reports, ensuring accuracy, completeness, and compliance with regulatory expectations.
Ø Conduct root cause analysis (RCA) for deviations, product complaints, and quality-related incidents.
Ø Work closely with production and quality teams to implement corrective and preventive measures based on investigation findings.
Ø Develop and maintain technical documentation to support manufacturing and quality processes.
Ø Develop CAPA plans with input from operators, Subject Matter Experts (SMEs), and management to ensure effective and sustainable solutions.
Ø Track and monitor CAPA action items to ensure timely completion and assess their effectiveness.
Ø Escalate unresolved CAPA items to management and recommend further actions as needed.
Ø Draft, review, and update Standard Operating Procedures (SOPs) to ensure alignment with regulatory requirements (e.g., FDA, GMP) and industry best practices.
Ø Collaborate with key stakeholders to ensure procedural updates align with internal standards, project timelines, and regulatory requirements.
Ø Provide training on new or updated SOPs, CAPAs, and procedural changes to relevant personnel.
Ø Ensure compliance with cGMPs, safety guidelines, and internal quality policies throughout the facility.
Supplemental Functions:
Ø Performs all other duties as assigned or apparent.
Ø Identify and document areas for improvement in manufacturing and quality systems to enhance efficiency and compliance.
Ø Support continuous improvement projects utilizing methodologies such as Lean and Six Sigma.
Ø Analyze manufacturing data and trends to drive process enhancements and prevent reoccurring quality issues.
Job Specifications and Qualifications:
Knowledge:
Ø Excellent technical writing skills with the ability to clearly document procedures and investigations.
Ø Strong analytical and problem-solving abilities.
Ø Proficiency in root cause analysis tools (e.g., Fishbone diagrams, 5 Whys).
Ø Proficient in Microsoft Office Suite and quality management software.
Ø Strong interpersonal and communication skills with the ability to collaborate effectively across departments.
Education / Experience:
Ø Bachelor's degree in Engineering, Life Sciences, Pharmacy, or a related field preferred.
Ø Certifications in Lean, Six Sigma, or similar continuous improvement methodologies are a plus.
Ø 3+ years of experience in a Quality Assurance, Technical Writing, or Investigation role, preferably in a BFS or pharmaceutical manufacturing environment.
Ø Strong background in SOP writing, CAPA management, investigation writing, and procedural updates.
Ø Working knowledge of regulatory requirements (e.g., FDA, EU GMP) and industry best practices is a plus.
Preferred Licensing and Certifications:
Ø Good Manufacturing Practices Certified Professional
Ø Certified Quality Auditor
Working Conditions / Physical Requirements:
Ø This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility.
About Nephron Pharmaceuticals
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
501 - 1,000 Employees
Headquarters location
West Columbia, SC, US
Year founded
1997