Lead Auditor CRS - Midwest Region

UL Solutions • Northbrook, IL

12d • $80,000 - $102,000 • Remote

About The Position

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: 21CFR211/210, Nutritional Supplements: 21CFR111, Medical/Homecare Devices: 21CFR820, Cosmetics: ISO22716.

Requirements

• High level of technical knowledge
• Ability to play an active mentoring role with trainees, auditors and lead auditors in the field.
• Competency in OTC Drug/Pharmaceuticals: 21CFR211/210
• Competency in Nutritional Supplements: 21CFR111
• Competency in Medical/Homecare Devices: 21CFR820
• Competency in Cosmetics: ISO22716
• Ability to complete audit agendas within 14 calendar days of the audit.
• Ability to complete reports within 4 calendar days of the audit.
• Ability to submit audit expenses in a timely manner.
• Ability to complete at least 10 days of audits per month minimum capacity.

Responsibilities

• 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.
• Write reports in English in an objective, accurate, detailed and timely manner.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed