Lead Auditor CRS

Job Description

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
• 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.

• 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.

• University Degree (Equivalent to Bachelor’s degree) required. Prefer Graduate Science Degree in Food or Pharma Sciences, Engineering, Technology, or similar.
• Must hold one or more scope specific professional credential(s), such as: GFSI recognized auditor credential; CQA, RABQSA, IRCA, RAC, Pharmaceutical GMP Professional Certification (CPGP)
• Four years related work experience in manufacturing or retail sectors in technical, supply chain, retail operations, quality assurance or food safety and/or equivalent experience in environmental health, public health or relevant experience.
• Willingness and ability to travel to other countries, states, regions, provinces and or throughout any assigned or designated country (up to 70 to 80% annually).
• Excellent written and verbal communication skills in English and if required fully proficient/literate in a 2nd language.
• Excellent oral communication skills; capable of addressing high executive audiences and conduct opening and closing conferences in front of multiple people.
• Excellent mathematical skills and analytical skills. Creative and innovative thinking to problem solve and streamline processes.
• Ability to lead a team of auditors during the execution of a project and/or specialized audits. Proficient in internet navigation, e-mail and PC software such as Microsoft Word, Excel.
• Ability to travel locally and regionally, and work remotely. This position does not generally report to a specific UL office.

• Total Rewards:
  We understand compensation is an important factor as you consider the…