Quality Audit & Validation Engineer

Autumn Harp is seeking a Quality Audit & Validation Engineer to support and strengthen our Quality Management System through supplier quality oversight, auditing, validation engineering, and regulatory compliance activities. This role combines supplier and internal auditing responsibilities with hands-on equipment and computer system validation in a GMP-regulated manufacturing environment.

Key Responsibilities:

Quality Auditing & Supplier Management

• Conduct supplier qualification, surveillance, and requalification audits.
• Maintain approved supplier records, risk assessments, audit schedules, and quality agreements.
• Lead and support internal audits, customer audits, regulatory inspections, and third-party assessments.
• Track audit findings, corrective actions (CAPAs), and ensure timely resolution.
• Support audit readiness initiatives, mock recalls, and continuous improvement efforts.

Validation Engineering

• Develop, execute, and maintain equipment and computer system validation protocols and reports (IQ/OQ/PQ).
• Support validation activities for laboratory and production equipment, utilities, and computerized systems.
• Perform risk assessments, manage validation deviations, and maintain audit-ready documentation.
• Ensure compliance with data integrity requirements, electronic records regulations, and applicable industry standards.
• Support process, cleaning, method, and product validation projects as needed.

Compliance & Continuous Improvement

• Support compliance with GMP, FDA, ISO, and customer requirements.
• Participate in change control, risk management, root cause investigations, and CAPA activities.
• Collaborate cross-functionally to drive quality improvements and maintain regulatory compliance.

Skills & Qualifications

• Bachelor’s degree in chemistry, Microbiology, Engineering, or a related scientific discipline.
• 5+ years of experience in GMP-regulated quality, auditing, validation, or compliance role.
• Working knowledge of GMP regulations, including 21 CFR Parts 11, 111, and 211, ISO/IEC 17025, ICH Q7, and GAMP 5.
• Experience conducting audits and supporting equipment, process, or computer system validation activities.
• Strong technical writing, organizational, communication, and problem-solving skills.
• Ability to travel by car and air and work at suppliers and manufacturing sites;
  approximately 25-40%.

Preferred

• ASQ Certified Quality Auditor (CQA), Lead Auditor certification, or similar credentials.
• Experience with supplier auditing, Quality Management Systems, and contract manufacturing environments.
• Familiarity with LIMS, ERP systems, electronic QMS platforms, and regulated computer system validation.
• Experience in cosmetics, personal care, pharmaceutical, OTC, or related manufacturing industries.
• Knowledge of Lean Manufacturing and continuous improvement methodologies.

Working Conditions

• Ability to work in office, laboratory, warehouse, and manufacturing environments.
• Daily exposure to fragrances and cosmetic manufacturing materials.
• Ability to travel and occasionally lift up to 30 pounds.

Join our team and help ensure the highest standards of quality, compliance, and continuous improvement while supporting innovative products in a dynamic manufacturing environment.

Compensation range: $80,000 - $100,000/annually