Reports To: CEO/President (independent of Production and QC)
Location: Phoenix, AZ – Onsite
Schedule: Part-Time (up to 30 hours/week, flexible)
Position Summary
The QA Specialist is responsible for developing, implementing, and maintaining AnuMed’s Quality Management System (QMS) in compliance with FDA 21 CFR Parts 111, 210, and 211 and requirements. This role provides oversight of documentation, training, audits, and regulatory readiness to ensure product quality and operational compliance.

Key Responsibilities

• Develop, review, and maintain SOPs, CAPAs, Deviations, and Change Controls in line with cGMP.
• Maintain QA documentation
• Ensure audit readiness: prepare for FDA, DEA, state, and third-party inspections.
• Conduct internal audits of Production, QC, Warehouse, and Documentation systems.
• Oversee training program: ensure personnel are trained, documented, and requalified as needed.
• Manage supplier qualification and raw material risk assessments (microbiological, COA verification, etc.).
• Approve and release Batch Manufacturing Records (BMRs) after QC testing completion.
• Oversee stability programs, validation protocols, and equipment qualification from a QA perspective.
• Support customer audits and provide quality documentation to clients (COAs, compliance forms, quality agreements).

Qualifications

• Bachelor’s degree in Chemistry, Biology, or related field.
• 3–5 years of QA experience in dietary supplements, pharmaceuticals, or biotech.
• Strong knowledge of FDA, DEA, cGMP regulations.
• Hands-on experience with CAPA, SOPs, training, audits, and validation protocols.
• Excellent attention to detail and organizational skills.
• Strong written and verbal communication.

Key Skills

• Regulatory compliance (FDA 111/210/211, DEA)
• Document control & QMS management
• Audit preparation and execution
• Training program management
• CAPA & deviation systems

Job Type: Part-time
Pay: $23.18 - $27.91 per hour
Expected hours: 25 – 35 per week
Work Location: In perso

• Develop, review, and maintain SOPs, CAPAs, Deviations, and Change Controls in line with cGMP.
• Maintain QA documentation
• Ensure audit readiness: prepare for FDA, DEA, state, and third-party inspections.
• Conduct internal audits of Production, QC, Warehouse, and Documentation systems.
• Oversee training program: ensure personnel are trained, documented, and requalified as needed.
• Manage supplier qualification and raw material risk assessments (microbiological, COA verification, etc.).
• Approve and release Batch Manufacturing Records (BMRs) after QC testing completion.
• Oversee stability programs, validation protocols, and equipment qualification from a QA perspective.
• Support customer audits and provide quality documentation to clients (COAs, compliance forms, quality agreements)