04 sep
|
Eurofins Healthcare Assurance
|
México
04 sep
Eurofins Healthcare Assurance
México
Locations:
Mexico (other Latin America countries are welcome)
Position Summary:
The Independent Contractor Auditor conducts third-party audits on behalf of Eurofins Assurance in accordance with Eurofins certification procedures and applicable regulatory, scheme, and standard requirements, including one or more of the following: GRMA, SSCI, 21 CFR Parts 111 and 117, ISO 22716, NSF/ANSI 455-2, NSF/ANSI 455-3, NSF/ANSI 455-4, EXCiPACT, and/or EFfCI. The auditor is responsible for evaluating objective evidence, documenting findings, and collecting and analyzing sufficient information to support accurate, impartial certification recommendations while maintaining confidentiality, technical competence, and compliance with Eurofins quality and accreditation requirements.
This role is suited for an experienced audit professional who can independently plan and conduct audits, evaluate conformity against applicable regulatory and certification requirements, and prepare objective, defensible reports that support Eurofins Assurance’s accredited certification programs. The auditor must demonstrate sound technical judgment, impartiality, professionalism, and the ability to represent Eurofins consistently in client-facing audit engagements.
Essential Duties and Responsibilities:
- Maintain applicable auditor qualifications and technical competency for assigned audit scopes, including one or more of the following: GRMA, SSCI, ISO 22716, 21 CFR Parts 111 and 117, ANSI 455-2, ANSI 455-3, ANSI 455-4, EXCiPACT, and EFfCI.
- Plan, manage, and execute all assigned audit activities, including audit preparation, scheduling, travel coordination, on-site or remote audit execution, client communication, report completion, and follow-up activities.
- Conduct audits in accordance with Eurofins certification procedures, applicable external scheme requirements, and accreditation rules.
- Collect, review, and evaluate objective evidence to determine conformity with applicable standards, regulations, and certification requirements.
- Prepare clear, accurate, complete, and timely audit reports that support impartial certification decisions and meet Eurofins, accreditation body, scheme owner, and client requirements.
- Identify, document, and communicate audit findings, including nonconformities, observations, and, where applicable to the program, opportunities for improvement.
- Review CAPA plans for acceptance when required by the applicable scheme or program.
- Participate in witness audits, surveillance audits, technical reviews, and other oversight activities required by Eurofins, accreditation bodies, or scheme owners.
- Complete required professional development, training, calibration, and competency activities to maintain auditor proficiency.
- Follow Eurofins quality manuals, policies, procedures, work instructions, SOPs, and applicable certification program requirements.
- Meet established agenda, audit report, CAPA, and service delivery deadlines.
Essential Qualities:
- Demonstrates integrity, impartiality, objectivity, confidentiality, and independence in all audit activities and certification-related interactions.
- Applies a risk-based, evidence-based, and process-oriented audit approach to support consistent and reliable audit outcomes.
- Exercises professional judgment, critical thinking, and systems thinking when evaluating conformity, product safety risks, and the effectiveness of management systems.
- Communicates clearly, factually, and professionally with clients, certification personnel, and other stakeholders, including when presenting audit findings or difficult conclusions.
- Maintains composure, fairness, tact, and professionalism in challenging audit situations while preserving auditor independence and audit integrity.
- Demonstrates technical curiosity and commitment to continual professional development, calibration, and competency maintenance.
- Conducts audit activities professionally and ethically, consistent with Eurofins, accreditation body, scheme owner,
and client requirements.
Qualifications:
- Bachelor’s degree in food science, pharmaceutical science, quality, bioscience, or a related technical discipline; alternatively, a minimum of 20 credit hours of relevant scientific coursework.
- Minimum of 3 years of relevant manufacturing, quality, regulatory, or auditing experience in dietary supplements, cosmetics, pharmaceuticals, food, or related regulated industries.
- Completed recognized HACCP training or equivalent professional experience.
- Completed recognized Lead Auditor training or has at least 3 years of lead auditor experience with an accredited certification body.
- Knowledge of GFSI-recognized schemes, GMP requirements, or accredited certification processes preferred.
Knowledge/Skills/Abilities:
- Working knowledge of applicable standards, regulations, certification schemes, and audit protocols relevant to assigned audit scopes.
- Strong written, verbal, interpersonal, and presentation skills, including the ability to communicate audit findings clearly and professionally.
- Ability to evaluate objective evidence, apply sound reasoning, and make well-founded conformity determinations during audits.
- Strong organizational skills, including the ability to manage multiple assignments, meet deadlines, and work independently.
- Ability to plan and execute domestic travel schedules as required for accepted audits.
- Ability to successfully complete Eurofins-supervised training, including witness audits, as required for auditor qualification.
- Authorization to work in the United States or assigned territory without restriction or sponsorship.
- English required; Spanish or other additional language skills preferred.
Rates:
Rates are based on experience and qualifications.
Eurofins is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.
📌 GxP and GMP Independent Contractor Auditor (México)
🏢 Eurofins Healthcare Assurance
📍 México