Sr. Lab Auditor

ROLE AT A GLANCE: 

 

 

HOW YOU’LL MAKE AN IMPACT:
External Laboratory Auditing
•    Lead, plan, and perform audits of external laboratories performing testing on behalf of the company.
•    Evaluate compliance with applicable regulations (e.g., ISO/IEC 17025, cGMP, GLP), internal standards, and contractual requirements.
•    Assess laboratory technical competency in areas such as method execution, instrumentation, data integrity, documentation, training, and quality control.
•    Identify risks, gaps, and non conformances; classify findings; and ensure audit conclusions are objective and evidence based.
•    Prepare high quality audit reports with clear findings, root cause insights, and recommended corrective and preventive actions (CAPA).
Vendor Qualification & Performance Oversight
•    Support qualification and onboarding of new external labs.
•    Work with cross-functional team to evaluate lab capabilities, equipment, capacity, and quality systems.
•    Monitor ongoing performance of external labs, including quality metrics, issue trends, and compliance history.
•    Conduct risk based requalification audits and maintain approved vendor status.
Quality & Compliance Leadership
•    Act as subject matter expert on laboratory compliance, laboratory quality systems, external testing oversight, and data integrity.
•    Collaborate with internal stakeholders to resolve quality events related to external lab testing.
•    Ensure alignment with internal Herbalife policies, global standards, and regulatory expectations.
•    Develop framework and support development of the company’s laboratory audit and compliance program. 
CAPA & Continuous Improvement
•    Work with external labs to ensure timely and effective CAPA responses.
•    Verify CAPA implementation and closure.
•    Identify and drive improvements in audit processes, templates, tools, and training.
•    Support harmonization of global quality standards and best practices.

•    Additional duties as assigned.

 

TEAM DYNAMICS:  
This role operates in a highly collaborative environment and plays a critical part in translating audit findings into clear, actionable operational language. Using a non‑adversarial, partnership‑focused approach, it fosters constructive dialogue that drives risk reduction and strengthens laboratory testing integrity. Although influencing without direct authority, the role significantly shapes and advances the organization’s auditing program.

 

LEADERSHIP AND SUPERVISORY RESPONSIBILITIES: 
•    Capability to influence external partners through professionalism and technical credibility. 
•    Strong decision making and risk based thinking.
•    Excellent communication, analytical, and technical writing skills. 
•    Strong organization and project management skills.
•    Ability to manage cross-functional relationships.

QUALIFICATIONS FOR SUCCESS: 

Education
•    Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry, Pharmaceutical Sciences, Engineering, or related field. 
•    7+ years of relevant experience in laboratory operations, quality assurance, auditing, or regulatory compliance.

 

Experience
•    Experience conducting audits (internal, external, or regulatory).
•    Strong knowledge of ISO/IEC 17025, cGMP, GLP, data integrity principles, and laboratory best practices.
•    Click here to type any additional relevant background experience required for this role.

 

Skills/Certifications 
•    ASQ Quality Auditor or Engineer Certification, ISO/IEC Lead Auditor Certification or equivalent
•    Ability to independently plan and execute complex audits of external laboratories.
•    Proficiency in writing clear, defensible audit reports and articulating audit findings.
•    Expertise in analytical testing techniques and ability to evaluate technical studies including method validation and equipment qualification
•    Competence in laboratory documentation review and working knowledge of LIMS
•    Ability to travel (typically 50-75%, depending on business needs).

 

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Herbalife offers a variety of benefits to eligible employees in the U.S. (limited to the 50 States and the District of Columbia), which includes Group Health Programs, other Voluntary Benefit Programs, and Paid Time Off. Group Health Programs include Medical, Dental, Vision, Health Savings Account (HSA), Flexible Spending Accounts (FSA), Basic Life/AD&D; Short-Term and Long-Term Disability, and an Employee Assistance Program (EAP). Other Voluntary Benefit Programs include a 401(k) plan, Wellness Incentive Program, Employee Stock Purchase Plan (ESPP), Supplemental Life/Critical Illness/Hospitalization/Accident Insurance, and Pet Insurance. Paid time off includes Company-observed U.S. Holidays, Floating Holidays, Vacation, Sick Time, a Volunteer Program, Paid Maternity and Paternity Leave, Bereavement Leave, Personal Leave and time off for voting.