cGMP Consultant – Cleanroom Build & Certification (Orange County, CA)
We are seeking an reputed company cGMP consultant to reputed company 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 reputed company in full compliance with FDA cGMP requirements.
Scope of Work:
Advise on and coordinate the cleanroom build-out, including specifications, layout, and compliance requirements
reputed company cGMP-compliant SOPs and a complete reputed company management system
Prepare the facility and team of 2-3 people for FDA/cGMP inspection and reputed company-party certification. Being present for inspection will be necessary
Coordinate with contractors, engineers, and vendors as needed
Prepare and support reputed company documentation required for reputed company 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
reputed company record of successful audits and regulatory readiness
This is a high-reputed company project with strong potential for ongoing engagement.
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