About Company
Are you driven by a commitment to public health and safety? Career.zycto is a dynamic, emerging consultancy firm dedicated to ensuring the highest standards of regulatory compliance across diverse industries. We partner with organizations to navigate complex regulatory landscapes, specializing in comprehensive audits, quality assurance, and strategic advisory services. For an FDA Inspector, our environment offers unparalleled opportunities to apply expertise across various sectors, fostering continuous professional growth and impactful contributions to consumer protection. Join a collaborative team where your insights directly shape industry best practices.
Job Description
Career.zycto is seeking a highly skilled and dedicated Full-Time FDA Inspector to join our growing team in South Side, Billings. This pivotal role involves safeguarding public health by ensuring compliance with FDA regulations across various client sites, primarily within the food, pharmaceutical, and medical device sectors. As an FDA Inspector, you will be responsible for conducting thorough inspections, identifying potential violations, and providing detailed reports that inform corrective actions.
This role is not just about identifying non-compliance; it’s about being a proactive partner in elevating industry standards. You will leverage your in-depth knowledge of FDA guidelines, including 21 CFR, GMP, GCP, and GLP, to perform comprehensive assessments of manufacturing processes, quality control systems, labeling practices, and record-keeping procedures. Your meticulous attention to detail and analytical prowess will be crucial in evaluating complex data, interviewing personnel, and collecting evidence to support your findings.
The successful candidate will thrive in a dynamic, field-based environment, often working independently or as part of a small team. You will be expected to travel frequently within the Billings area and potentially to surrounding regions, adapting to diverse operational settings and stakeholder interactions. Strong interpersonal and communication skills are paramount, as you will be responsible for clearly articulating findings to facility management, discussing regulatory requirements, and fostering a collaborative approach to compliance improvement.
At Career.zycto, we believe in continuous learning and professional development. This position offers a unique opportunity to expand your expertise across multiple industry verticals, staying ahead of evolving regulatory frameworks. You will contribute directly to client success and, more broadly, to public safety and confidence in regulated products. If you are passionate about upholding regulatory integrity and possess the expertise to drive meaningful change, we encourage you to apply for this impactful role. Your contributions will be integral to our mission of excellence in regulatory assurance and client empowerment.
Key Responsibilities
- Conduct comprehensive, on-site inspections of food, pharmaceutical, and medical device facilities to assess compliance with FDA regulations (e.g., 21 CFR, GMP, GCP, GLP).
- Evaluate manufacturing processes, quality control systems, sanitation practices, labeling, packaging, and record-keeping for adherence to regulatory standards.
- Identify deviations, deficiencies, and potential violations of FDA requirements.
- Document inspection findings accurately and thoroughly, preparing detailed inspection reports.
- Collect and analyze samples, evidence, and other pertinent information to support findings.
- Interview facility personnel to gather information regarding operations, procedures, and quality systems.
- Communicate inspection results, regulatory requirements, and corrective action recommendations to facility management in a clear and professional manner.
- Provide expert guidance on best practices for achieving and maintaining FDA compliance.
- Stay current with changes in FDA regulations, guidance documents, and industry best practices.
- Participate in follow-up inspections and verification of corrective actions.
Required Skills
- In-depth knowledge of FDA regulations (21 CFR Parts 11, 58, 210, 211, 820, etc.), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
- Proven experience conducting regulatory inspections or audits within FDA-regulated industries (food, pharmaceutical, medical device).
- Strong analytical and critical thinking skills to interpret complex data and regulatory documents.
- Excellent written and verbal communication skills for report writing and stakeholder interaction.
- Ability to work independently and as part of a team in various operational environments.
- Proficiency in collecting and documenting evidence and maintaining meticulous records.
- Demonstrated ability to maintain objectivity and professional judgment during inspections.
Preferred Qualifications
- Bachelor's degree in Science, Engineering, Pharmacy, Public Health, or a related field.
- Certifications in regulatory affairs (e.g., RAC) or quality auditing (e.g., ASQ Certified Quality Auditor).
- Experience with different types of inspections (e.g., pre-approval, routine, for-cause).
- Familiarity with international regulatory standards (e.g., ICH, ISO).
- Experience in conducting training or workshops on FDA compliance.
Perks & Benefits
- Competitive salary and comprehensive benefits package.
- Opportunities for continuous professional development and training.
- Dynamic and collaborative work environment.
- Mileage reimbursement and travel stipends.
- Generous paid time off and holidays.
- Health, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Impactful work contributing directly to public health and safety.
How to Apply
We invite qualified candidates to submit their application by clicking the link below. Please ensure your resume and cover letter highlight your relevant experience and expertise in FDA regulatory compliance and inspections. We look forward to reviewing your application.
