Lead Auditor CRS - Midwest Region

UL Solutions•Marietta, GA

1d•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 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.

Requirements

University Degree (Equivalent to Bachelor’s degree) required.
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.
Candidate needs to be located close to airport due to high travel requirements.

Nice To Haves

Graduate Science Degree in Food or Pharma Sciences, Engineering, Technology, or similar.

Responsibilities

Perform high level assessments of quality systems in a variety of manufacturing sites, farms, processing plants and/or other work related sites.
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.
Play an active mentoring role with trainees, auditors and lead auditors in the field.
Participate and lead higher level audits involving 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.