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
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Job Type
Full-time
Career Level
Mid Level
Industry
Professional, Scientific, and Technical Services
Number of Employees
5,001-10,000 employees