Maintain expert knowledge of FDA, EMA, and other global regulatory requirements for sterile product inspection. People Development & Team Leadership * Recruit, develop, and retain high-performing ...
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Maintain expert knowledge of FDA, EMA, and other global regulatory requirements for sterile product inspection. People Development & Team Leadership * Recruit, develop, and retain high-performing ...
Quick apply
Maintain expert knowledge of FDA, EMA, and other global regulatory requirements for sterile product inspection. People Development & Team Leadership * Recruit, develop, and retain high-performing ...
$166K - $228K/yr
Participate as a microbiology SME in internal audits, and external audits such as FDA inspections, ISO certifications, surveillance audits and customer audits. * Maintain a strong working knowledge ...
$166K - $228K/yr
Participate as a microbiology SME in internal audits, and external audits such as FDA inspections, ISO certifications, surveillance audits and customer audits. * Maintain a strong working knowledge ...
... and FDA 21 CFR 820 requirements as well as company protocols. Job Responsibilities: Adheres to ... Complete required documentation and inspection operations with detail, accuracy, and precision.
... and FDA 21 CFR 820 requirements as well as company protocols. Job Responsibilities: Adheres to ... Complete required documentation and inspection operations with detail, accuracy, and precision.
Plymouth, IN · On-site
$80K - $109K/yr
Assisting with Customer Audits, Internal Audits, Notified Body Audits, and FDA Inspections * Assisting with Supplier Management (including but not limited to supplier performance review, and supplier ...
Plymouth, IN · On-site
$80K - $109K/yr
Assisting with Customer Audits, Internal Audits, Notified Body Audits, and FDA Inspections * Assisting with Supplier Management (including but not limited to supplier performance review, and supplier ...
$80K - $109K/yr
Assisting with Customer Audits, Internal Audits, Notified Body Audits, and FDA Inspections * Assisting with Supplier Management (including but not limited to supplier performance review, and supplier ...
$80K - $109K/yr
Assisting with Customer Audits, Internal Audits, Notified Body Audits, and FDA Inspections * Assisting with Supplier Management (including but not limited to supplier performance review, and supplier ...
Plymouth, IN · On-site
$80K - $109K/yr
Assisting with Customer Audits, Internal Audits, Notified Body Audits, and FDA Inspections * Assisting with Supplier Management (including but not limited to supplier performance review, and supplier ...
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Plymouth, IN · On-site
$80K - $109K/yr
Assisting with Customer Audits, Internal Audits, Notified Body Audits, and FDA Inspections * Assisting with Supplier Management (including but not limited to supplier performance review, and supplier ...
Prepare and assist in follow-up for FDA Inspections. Be available to host the inspection if requested. * Conduct advanced training for physicians and APPs interested in conducting research at IHI.
Prepare and assist in follow-up for FDA Inspections. Be available to host the inspection if requested. * Conduct advanced training for physicians and APPs interested in conducting research at IHI.
Prepare and assist in follow-up for FDA Inspections. Be available to host the inspection if requested. * Conduct advanced training for physicians and APPs interested in conducting research at IHI.
Quick apply
Prepare and assist in follow-up for FDA Inspections. Be available to host the inspection if requested. * Conduct advanced training for physicians and APPs interested in conducting research at IHI.
Prepare and assist in follow-up for FDA Inspections. Be available to host the inspection if requested. * Conduct advanced training for physicians and APPs interested in conducting research at IHI.
Prepare and assist in follow-up for FDA Inspections. Be available to host the inspection if requested. * Conduct advanced training for physicians and APPs interested in conducting research at IHI.
Granger, IN · On-site
Preparing for and supporting successful completion of annual FDA inspections and accreditation surveys. * Ordering and restocking supplies to ensure mammography and exam rooms are adequately equipped.
Granger, IN · On-site
Preparing for and supporting successful completion of annual FDA inspections and accreditation surveys. * Ordering and restocking supplies to ensure mammography and exam rooms are adequately equipped.
Be Seen First
Avon, IN · On-site
$70K - $90K/yr
... ISO 13485, FDA Quality System Regulations, corrective and preventive action systems, documentation control, inspection processes, and manufacturing support. The ideal candidate will be detail ...
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Be Seen First
Avon, IN · On-site
$70K - $90K/yr
... ISO 13485, FDA Quality System Regulations, corrective and preventive action systems, documentation control, inspection processes, and manufacturing support. The ideal candidate will be detail ...
Fishers, IN · On-site
$30/hr
This position requires a strong understanding of quality systems, inspection techniques, and regulatory compliance, particularly in industries governed by ISO 13485 and FDA regulations. Requirements
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Fishers, IN · On-site
$30/hr
This position requires a strong understanding of quality systems, inspection techniques, and regulatory compliance, particularly in industries governed by ISO 13485 and FDA regulations. Requirements
Indianapolis, IN · On-site
Self-inspections * Audit readiness Regulatory Knowledge * In-depth understanding of FDA/ICH/EU cGMP regulations and guidelines Data Integrity * Experience with Data Integrity principles (ALCOA+
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Indianapolis, IN · On-site
Self-inspections * Audit readiness Regulatory Knowledge * In-depth understanding of FDA/ICH/EU cGMP regulations and guidelines Data Integrity * Experience with Data Integrity principles (ALCOA+
... Inspection and In-Process Controls, CAPA, and Training. * Familiarity with ISO 14971 risk management principles and FDA 510(k) / Class II submission processes is advantageous. * Demonstrated ...
... Inspection and In-Process Controls, CAPA, and Training. * Familiarity with ISO 14971 risk management principles and FDA 510(k) / Class II submission processes is advantageous. * Demonstrated ...
... Inspection and In-Process Controls, CAPA, and Training. * Familiarity with ISO 14971 risk management principles and FDA 510(k) / Class II submission processes is advantageous. * Demonstrated ...
... Inspection and In-Process Controls, CAPA, and Training. * Familiarity with ISO 14971 risk management principles and FDA 510(k) / Class II submission processes is advantageous. * Demonstrated ...
Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to process validation activities. * Working knowledge of statistical tools and software used for ...
Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to process validation activities. * Working knowledge of statistical tools and software used for ...
Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to process validation activities. * Working knowledge of statistical tools and software used for ...
Quick apply
Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to process validation activities. * Working knowledge of statistical tools and software used for ...
Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to process validation activities. * Working knowledge of statistical tools and software used for ...
Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to process validation activities. * Working knowledge of statistical tools and software used for ...
Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to process validation activities. * Working knowledge of statistical tools and software used for ...
Quick apply
Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to process validation activities. * Working knowledge of statistical tools and software used for ...
Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to process validation activities. Working knowledge of statistical tools and software used for ...
Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to process validation activities. Working knowledge of statistical tools and software used for ...
$23.3K - $29.8K
3% of jobs
$29.8K - $36.2K
16% of jobs
$37.8K is the 25th percentile. Wages below this are outliers.
$36.2K - $42.6K
23% of jobs
The median wage is $44.6K / yr.
$42.6K - $49.1K
27% of jobs
$53.2K is the 75th percentile. Wages above this are outliers.
$49.1K - $55.5K
10% of jobs
$55.5K - $62K
4% of jobs
$62K - $68.4K
5% of jobs
$68.4K - $74.9K
2% of jobs
$74.9K - $81.3K
2% of jobs
$81.3K - $87.8K
2% of jobs
$87.8K - $94.2K
5% of jobs
$23.3K
$52.3K
$94.2K
An FDA Inspector is responsible for ensuring that companies comply with federal regulations related to food, drugs, medical devices, and other products overseen by the U.S. Food and Drug Administration. They conduct inspections, review records, collect samples, and assess manufacturing practices to ensure public health and safety. Inspectors may also investigate complaints, issue compliance notices, and recommend enforcement actions if violations are found.
To thrive as an FDA Inspector, you need a solid background in science or public health, attention to detail, and thorough knowledge of regulatory standards, often supported by a relevant degree. Familiarity with inspection protocols, laboratory testing equipment, and digital reporting systems is commonly required, along with potential USDA or FDA certifications. Strong analytical thinking, effective communication, and integrity are important soft skills for this role. These competencies ensure accurate inspections, compliance with safety regulations, and clear reporting essential to public health and organizational accountability.
FDA Inspectors routinely examine a variety of facilities, such as food processing plants, pharmaceutical manufacturers, medical device companies, and cosmetic production sites, to ensure compliance with federal safety and quality regulations. A typical inspection involves reviewing operational procedures, examining production environments, sampling products, and interviewing staff to identify potential violations or risks. Inspectors often work onsite, sometimes with travel required to cover multiple locations within their region, and collaborate closely with facility management to explain findings and recommend corrective actions. This role offers the opportunity to make a significant impact on public health and provides clear advancement pathways into specialized inspection or supervisory roles within regulatory agencies.
For Fda Inspector jobs in Indiana, the most frequently searched job titles are:
The top searched job categories for Fda Inspector jobs in Indiana are:

Manager of Inspection Summary
INCOG BioPharma is seeking a seasoned leader with extensive subject matter expertise in the inspection and packaging of sterile drug products. The primary purpose of this role is to provide strategic leadership, operational management, and technical excellence across our 24/5 inspection operations, overseeing three shifts of Inspection Supervisors and their teams.
The Manager of Inspection will be responsible for the overall vision, strategy, and execution of the visual inspection program within INCOG BioPharma Operations. This role will drive continuous improvement, ensure regulatory compliance, develop talent across all shifts, and serve as the primary liaison between inspection operations and senior leadership.
Essential Job Functions:
Strategic Leadership & Program Management
Develop and execute the strategic vision for the inspection department, including short-term and long-term goals aligned with company objectives.
Oversee the implementation, optimization, and continuous improvement of the visual inspection program across all shifts.
Lead cross-functional initiatives to advance inspection technologies, automation, and packaging capabilities.
Establish and monitor key performance indicators (KPIs) and quality metrics for inspection operations.
Operational Management & Multi-Shift Oversight
Provide direct leadership and management to three Inspection Supervisors (1-2 per shift) and indirect oversight of their inspection teams.
Ensure seamless 24/5 inspection operations through effective shift coordination, scheduling, and resource allocation.
Monitor production schedules, capacity planning, and workflow optimization across all shifts.
Coordinate with the supervisors to host shift handoffs to ensure continuity of operations and communication flow.
Resolve escalated operational issues and ensure rapid response to production challenges.
Quality & Regulatory Compliance
Ensure compliance with cGMP requirements (current good manufacturing practices) across all inspection operations.
Serve as the subject matter expert for regulatory inspections related to visual inspection and packaging.
Develop, review, and approve visual inspection specifications, SOPs, and batch records.
Lead deviation investigations, CAPA initiatives, and risk assessments related to inspection operations.
Interface with Quality Assurance, Quality Control, and Regulatory on compliance matters.
Maintain expert knowledge of FDA, EMA, and other global regulatory requirements for sterile product inspection.
People Development & Team Leadership
Recruit, develop, and retain high-performing Inspection Supervisors and team members.
Conduct performance management, coaching, and career development for direct reports.
Establish training programs and competency assessments for visual inspection personnel across all shifts.
Foster a culture of accountability, continuous learning, and operational excellence.
Promote cross-shift collaboration and knowledge sharing.
Champion employee engagement, safety, and INCOG’s core values.
Technical Expertise & Innovation
Provide technical guidance on automated visual inspection systems, semi-automated equipment, and manual inspection processes.
Evaluate and implement new inspection technologies and packaging innovations.
Lead qualification and validation activities for inspection equipment and processes (IQ/OQ/PQ).
Collaborate with Engineering, Technical Services, and external vendors on equipment optimization.
Stay current with industry best practices, emerging technologies, and regulatory trends.
Cross-Functional Collaboration
Partner with Manufacturing, Quality, Supply Chain, and Technical Services to ensure seamless operations.
Represent inspection operations in management meetings, production planning sessions, and strategic initiatives.
Support client audits, regulatory inspections, and customer presentations.
Collaborate with Business Development on new product assessments and feasibility studies.
Special Job Requirements:
Functional knowledge of industry guidance and requirements applicable to visual inspection, including USP <790> and <1790>; FDA Draft Guidance: Inspection of Injectable Products for Visible Particulates (2021); PDA Technical Reports, and European Pharmacopoeia 2.9.20: Particulate Contamination: Visible Particles
Awareness of industry trends, including FDA actions, in manual and automated inspection processes
SME on Knapp-Abramson Analysis Framework, individual certification for manual visual inspection, defect kit creation, qualification, and control; and qualification strategies for SASI and AIM
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
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Biotechnology research and development
51 - 200 Employees
Fishers, IN, US
2020