About the job cGMP Audit Specialist
About the Client:
The client is a forward-thinking manufacturing company dedicated to making a positive impact on the world. Based in Hildale, Utah, they take pride in fostering a supportive, results-driven culture where every team member contributes to achieving shared goals. As an equal opportunity employer, the company values professionalism, integrity, and innovation in everything they do.
About the Role:
We are seeking a cGMP Audit Specialist (Regulatory Compliance Inspector) to join our team in Hildale, UT. This is a full-time, in-person position responsible for ensuring compliance with regulatory requirements and company standards across production and manufacturing processes. Reporting directly to management, you will play a key role in maintaining quality, safety, and operational excellence.
Key Responsibilities:
- Perform routine checklist inspections across company operations.
- Conduct audits to ensure compliance with cGMP, FDA, and OSHA standards.
- Prepare clear and detailed reports, including observations and recommendations.
- Enforce company policies, Standard Operating Procedures (SOPs), and 21 CFR part 111 requirements.
- Monitor and report significant actions or events as needed.
- Support and collaborate with team members to achieve operational goals.
- Participate in staff meetings, trainings, and continuous improvement initiatives.
Qualifications:
Required:
- Proven experience in production/manufacturing and quality control.
- Strong attention to detail, clear communication, and organizational skills.
- Familiarity with SOPs and 21 CFR part 111.
- Ability to work a flexible schedule (Monday-Friday, 5:00 a.m.2:00 p.m.).
- Must not be color blind.
Preferred:
- Experience working with FDA, OSHA, and cGMP standards.
- Background in quality control, manufacturing, or warehouse operations.
- Food handlers permit.
- Problem-solving and troubleshooting skills, with a calm and rational approach.
- Professional demeanor, integrity, and self-motivation.