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Fda Inspector Jobs in Miami, FL (NOW HIRING)

Monitor manufacturing areas for compliance with internal SOPs, cGMPs and FDA/DEA regulations ... Perform required inspections and testing of in-process items and finished products. Process and ...

Monitor manufacturing areas for compliance with internal SOPs, cGMPs and FDA/DEA regulations ... Perform required inspections and testing of in-process items and finished products. Process and ...

Inspect and approve rooms, lines and equipment prior to use by manufacturing and R&D personnel ... Monitor manufacturing areas for compliance with internal SOPs, cGMPs and FDA/DEA regulations.

Inspect and approve rooms, lines and equipment prior to use by manufacturing and R&D personnel ... Monitor manufacturing areas for compliance with internal SOPs, cGMPs and FDA/DEA regulations.

Inspect and approve rooms, lines and equipment prior to use by manufacturing and R&D personnel ... Monitor manufacturing areas for compliance with internal SOPs, cGMPs and FDA/DEA regulations.

Monitor manufacturing areas for compliance with internal SOPs, cGMPs and FDA/DEA regulations ... Perform required inspections and testing of in-process items and finished products. Process and ...

Performs Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP's, Safety initiatives, Company policies, FDA and ...

Experience in supporting FDA inspections as a quality system subject matter expert and an ability to interpret regulatory requirements. * Detail oriented and possess a professional demeanor, be ...

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Fda Inspector information

See Miami, FL salary details

$23.4K

$52.5K

$94.7K

How much do fda inspector jobs pay per year?

As of Aug 15, 2026, the average yearly pay for fda inspector in Miami, FL is $52,546.00, according to ZipRecruiter salary data. Most workers in this role earn between $36,800.00 and $60,700.00 per year, depending on experience, location, and employer.

What types of facilities or products do FDA inspectors review, and what does a typical inspection process involve?

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.

What skills and qualifications are needed to be an FDA inspector?

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.

How do you become an FDA inspector?

To become an FDA inspector, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or food science, along with experience in food safety, pharmaceuticals, or related areas. They must pass the FDA's specialized training program and often require a background check and security clearance; some positions may also require state licensure or certifications. Strong attention to detail, knowledge of regulatory standards, and good communication skills are essential for the role.

What does an FDA inspector do?

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.

What are popular job titles related to Fda Inspector jobs in Miami, FL?

For Fda Inspector jobs in Miami, FL, the most frequently searched job titles are:

What cities near Miami, FL are hiring for Fda Inspector jobs?

Cities near Miami, FL with the most Fda Inspector job openings:

Infographic showing various Fda Inspector job openings in Miami, FL as of August 2026, with employment types broken down into 75% Full Time, 12% Part Time, 12% Contract, and 1% Nights. Highlights an 98% Physical, and 2% Remote job distribution, with an average salary of $52,546 per year, or $25.3 per hour.

Design Controls Specialist

AVEVA DRUG DELIVERY SYSTEMS INC

Miramar, FL • On-site

Full-time

Re-posted 27 days ago


Job description

Job Summary: 

The Design Controls Specialist is responsible for establishing, maintaining, and ensuring compliance of design control processes in accordance with regulatory requirements (FDA 21 CFR Part 820, ISO 13485, and applicable combination product guidelines). This role will own and manage Design History Files (DHF) and oversee product lifecycle management for transdermal drug delivery systems, ensuring traceability, risk management, and design integrity from concept through commercialization and post-market changes.

Job Responsibilities:

Design Control & Design History File (DHF) Management

  • Lead the creation, organization, review, and maintenance of Design History Files (DHF) for transdermal patch products.
  • Ensure DHFs demonstrate full compliance with:
    • FDA 21 CFR 820.30 (Design Controls)
    • ISO 13485 design and development requirements
    • Combination product regulations (21 CFR Part 4)
  • Maintain complete design traceability from:
    • User needs → Design inputs → Outputs → Verification → Validation → Design transfer
  • Perform routine audits and gap assessments of DHFs to ensure completeness and inspection readiness.
  • Ensure proper version control and document integrity within electronic document management systems (e.g. Trackwise).

Design Lifecycle Management

  • Support end-to-end product lifecycle management for transdermal patches:
    • Concept development
    • Feasibility and design planning
    • Verification & validation
    • Commercialization
    • Post-market lifecycle management
  • Drive and manage design changes (ECR/ECN) ensuring proper documentation, impact assessments, and approvals.
  • Collaborate with cross-functional teams to ensure lifecycle activities meet regulatory and quality expectations.

Risk Management & Compliance

  • Facilitate and maintain risk management documentation (ISO 14971 aligned), including:
    • Risk analyses (FMEA, FTA)
    • Risk control measures
    • Risk-benefit justifications
  • Ensure integration of risk management into design controls and lifecycle activities.
  • Support internal and external audits, including FDA inspections and notified body audits.
  • Act as subject matter expert on design control compliance for transdermal systems

Cross-Functional Collaboration

  • Partner with:
    • R&D / Formulation Scientists
    • Engineering (process, packaging, and equipment)
    • Quality Assurance & Regulatory Affairs
    • Manufacturing and Operations
  • Ensure alignment between product design, process design, and manufacturing transfer.
  • Support Design Transfer activities ensuring readiness for commercial production.

Documentation & Systems

  • Maintain and improve Quality Management System (QMS) procedures related to design controls.
  • Develop templates, SOPs, and best practices for DHF and lifecycle documentation.
  • Ensure all documentation supports labeling, stability, and performance requirements of transdermal patches.
  • Support digital transformation of DHF and lifecycle records when applicable.
  • All other duties as assigned.
Job Requirements
  • Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or related field.
  • 3–7+ years of experience in:
    • Medical device, pharmaceutical, or combination product industries
    • Design controls and DHF management
  • Strong knowledge of:
    • FDA 21 CFR Part 820 and Part 4 (combination products)
    • ISO 13485 and ISO 14971
    • Design verification and validation processes
  • Experience with document control systems (e.g., TrackWise).

Knowledge, Skills and Abilities

  • Experience with transdermal drug delivery systems or combination products.
  • Knowledge of adhesives, drug-in-adhesive systems, or patch manufacturing technologies.
  • Familiarity with process validation and technology transfer
  • Experience supporting FDA inspections or regulatory submissions (e.g., NDA, ANDA, 510(k)).
  • Strong attention to detail and documentation rigor
  • Excellent organizational and traceability management skills
  • Ability to interpret and apply complex regulations
  • Cross-functional leadership and collaboration
  • Problem-solving and risk-based thinking
  • Audit readiness mindset