Lead Auditor CRS
Allentown, PA, United States
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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- 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, GRMA; 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.
What we offer:
- Total Rewards: We understand compensation is an important factor as you consider the next step in your …
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Annual bonus Annual Bonus Compensation Bonus compensation Health benefits Holidays Paid Time Off Retirement savings Sick time Vacation Wellness benefits
Tasks- Perform quality audits
- Write detailed reports
Analytical Audit Auditing Audits Certification Communication Engineering Excel Food Safety GMP Internet navigation Manufacturing Mathematical Mentoring Microsoft Excel Microsoft Word Operations Problem-solving Quality Assurance Quality Systems Regulatory standards Reports Software Standards Team Leadership Technical knowledge Word
Experience4 years
EducationBachelor's degree Engineering Equivalent University Degree
Certifications TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9