cGMP Consultant – Cleanroom Build & Certification (Orange County, CA)
We are seeking an experienced cGMP consultant to lead the design, build-out, and certification of a small (1000 sq ft) cleanroom facility in Orange County, California. Our objective is to manufacture powder-based products for sale on Amazon in full compliance with FDA cGMP requirements. Scope of Work: Advise on and coordinate the cleanroom build-out, including specifications, layout, and compliance requirements Develop cGMP-compliant SOPs and a complete quality management system Prepare the facility and team of 2-3 people for FDA/cGMP inspection and third-party certification. Being present for inspection will be necessary Coordinate with contractors, engineers, and vendors as needed Prepare and support all documentation required for Amazon and regulatory compliance Ideal Candidate: Demonstrated, hands-on experience with FDA cGMP (dietary supplements or similar regulated products) Proven background in cleanroom design and facility certification Track record of successful audits and regulatory readiness This is a high-impact project with strong potential for ongoing engagement. Apply tot his job