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 Now
Apply Now