GMP Consultant (NSF/ANSI 455-2 & 21 CFR Part 111)
Budget: $50 – $0 USD
Overview
We are seeking an experienced GMP Consultant with deep expertise in NSF/ANSI 455-2 and 21 CFR Part 111 to help create and finalize and audit-proof our GMP documentation system in preparation for a third-party certification audit.
This role is execution-focused. We are not looking for high-level advice—we need someone who can build, refine, and finalize audit-ready documentation and ensure we pass certification.
________________________________________
Scope of Work
The consultant will be responsible for reviewing, developing, and finalizing a complete GMP documentation system, including:
1. Quality Manual
• Review and finalize all sections for audit readiness
• Ensure alignment with NSF/ANSI 455-2 and 21 CFR Part 111
• Close any compliance gaps
________________________________________
2. SOP Development & Finalization
• Supplier Qualification
• Receiving, Quarantine, and Release
• Production & Batch Records (MMR/BPR)
• Cleaning & Sanitation
• Equipment Calibration
• Complaint Handling & CAPA
• Recall Procedures
• Document Control
________________________________________
3. Forms, Logs, and Records
Develop and/or finalize:
• Approved Supplier List (ASL)
• COA Verification Logs
• Identity Testing Logs
• Cleaning Logs
• Training Records
• Deviation & CAPA Logs
• Batch Production Records
________________________________________
4. Audit Readiness
• Conduct a mock audit (Eurofins-style)
• Identify and correct deficiencies
• Ensure all documentation is:
o Consistent
o Complete
o Cross-referenced
• Prepare team for audit expectations
________________________________________
5. Regulatory Compliance Verification
• Ensure:
o Identity testing requirements are met
o COA reliance is properly justified
o QC authority is clearly defined and enforced
• Align procedures with real-world audit expectations
________________________________________
Qualifications
• Proven experience with:
o NSF/ANSI 455-2 certification audits
o 21 CFR Part 111 compliance
• Experience preparing companies for third-party GMP audits (Eurofins, NSF, UL, etc.)
• Strong background in:
o Dietary supplements
o Functional beverages or similar manufacturing environments
• Demonstrated ability to:
o Build audit-ready SOPs and documentation
o Identify compliance gaps quickly
o Work in fast-paced environments
________________________________________
Preferred Experience
• Experience with Amazon GMP requirements
• Experience with small to mid-size manufacturing operations
• Hands-on experience in:
o Batch record design (MMR/BPR)
o Supplier qualification systems
o Identity testing programs
________________________________________
Deliverables
• Fully audit-ready GMP documentation system
• Gap assessment report
• Completed SOPs, logs, and templates
• Mock audit report with corrective actions
________________________________________
Engagement Details
• Short-term, high-impact engagement
• Immediate start preferred
• Flexible hours, but must meet deadlines
________________________________________
Application Instructions
To apply, please include:
1. A brief summary of your experience with NSF/ANSI 455-2 and 21 CFR Part 111
2. Examples of GMP systems or audits you have supported
3. Your availability and estimated timeline
4. Start your application with:
We are seeking an experienced GMP Consultant with deep expertise in NSF/ANSI 455-2 and 21 CFR Part 111 to help create and finalize and audit-proof our GMP documentation system in preparation for a third-party certification audit.
This role is execution-focused. We are not looking for high-level advice—we need someone who can build, refine, and finalize audit-ready documentation and ensure we pass certification.
________________________________________
Scope of Work
The consultant will be responsible for reviewing, developing, and finalizing a complete GMP documentation system, including:
1. Quality Manual
• Review and finalize all sections for audit readiness
• Ensure alignment with NSF/ANSI 455-2 and 21 CFR Part 111
• Close any compliance gaps
________________________________________
2. SOP Development & Finalization
• Supplier Qualification
• Receiving, Quarantine, and Release
• Production & Batch Records (MMR/BPR)
• Cleaning & Sanitation
• Equipment Calibration
• Complaint Handling & CAPA
• Recall Procedures
• Document Control
________________________________________
3. Forms, Logs, and Records
Develop and/or finalize:
• Approved Supplier List (ASL)
• COA Verification Logs
• Identity Testing Logs
• Cleaning Logs
• Training Records
• Deviation & CAPA Logs
• Batch Production Records
________________________________________
4. Audit Readiness
• Conduct a mock audit (Eurofins-style)
• Identify and correct deficiencies
• Ensure all documentation is:
o Consistent
o Complete
o Cross-referenced
• Prepare team for audit expectations
________________________________________
5. Regulatory Compliance Verification
• Ensure:
o Identity testing requirements are met
o COA reliance is properly justified
o QC authority is clearly defined and enforced
• Align procedures with real-world audit expectations
________________________________________
Qualifications
• Proven experience with:
o NSF/ANSI 455-2 certification audits
o 21 CFR Part 111 compliance
• Experience preparing companies for third-party GMP audits (Eurofins, NSF, UL, etc.)
• Strong background in:
o Dietary supplements
o Functional beverages or similar manufacturing environments
• Demonstrated ability to:
o Build audit-ready SOPs and documentation
o Identify compliance gaps quickly
o Work in fast-paced environments
________________________________________
Preferred Experience
• Experience with Amazon GMP requirements
• Experience with small to mid-size manufacturing operations
• Hands-on experience in:
o Batch record design (MMR/BPR)
o Supplier qualification systems
o Identity testing programs
________________________________________
Deliverables
• Fully audit-ready GMP documentation system
• Gap assessment report
• Completed SOPs, logs, and templates
• Mock audit report with corrective actions
________________________________________
Engagement Details
• Short-term, high-impact engagement
• Immediate start preferred
• Flexible hours, but must meet deadlines
________________________________________
Application Instructions
To apply, please include:
1. A brief summary of your experience with NSF/ANSI 455-2 and 21 CFR Part 111
2. Examples of GMP systems or audits you have supported
3. Your availability and estimated timeline
4. Start your application with: