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UL Solutions · 1 day ago

Consumer Products Lead Auditor CRS

Allentown, PA

Full-time

Hybrid

Mid, Senior Level

$80K/yr - $102K/yr

4+ years exp

UL Solutions is a global leader in applied safety science, providing testing, inspection, and certification services. They are seeking a Lead Auditor for GMP Quality Audits to assess quality systems in various manufacturing sites, maintain technical knowledge, and lead complex audits in compliance with industry standards.

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Responsibilities

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

Qualification

GMP Quality AuditsRegulatory Standards CompetencyProfessional CertificationAnalytical SkillsTeam LeadershipMathematical SkillsPC Software ProficiencyCommunicationCreative Problem Solving

Required

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

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