Lead Auditor CRS - Midwest Region

Lead Auditor - GMP Quality Audits will perform high level assessments of quality systems in a variety of manufacturing sites, farms, processing plants and/or other work related sites throughout a region or country.

• Assess and report in accordance with UL, industry scheme, and client audit protocols on facilities working and/or operational conditions as it relates to established industry standard(s) for GMP, Quality Systems, Food Safety initiatives and/or client programs.
• Maintain a high level of technical knowledge and play an active mentoring role with trainees, auditors and lead auditors in the field.
• Participate and lead higher level audits; and as such this will involve complex methodologies, advanced analysis, and comprehensive / intricate reporting. Reports will be written in English in an objective, accurate, detailed and timely manner.
• Specific Regulatory Standard(s) Competency are a focus including:
  • OTC Drug/Pharmaceuticals: 21
    
    CFR
    211/210
  • Nutritional Supplements: 21
    
    CFR
    111
  • Medical/Homecare Devices: 21
    
    CFR
    820
  • Cosmetics: ISO
    22716
• Complete audit agendas within 14 calendar days of the audit
• Complete reports within 4 calendar days of the audit
• Submit audit expenses in a timely manner
• Complete at least 10 days of audits per month minimum capacity.