Quality Assurance (QA) Auditor IV – Bioanalysis

Are you an experienced LCMS scientist? Do you have auditing experience with GLP/GCP? If so, we want you to join our Global QA team as a Quality Assurance (QA) Auditor IV in Madison, WI.

Labcorp Drug Development’s work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.

We are offering a sign-on bonus of $4,000 (paid 60 days after employment ; external candidates only)

Position Overview

• Requires working knowledge of LC/MS bioanalysis, FDA Guidance for Industry: Bioanalytical Method Validation

• Audits bioanalytical validation and sample analysis

• Interprets applicable quality regulations/standards and creates appropriate policies and procedures

• Manages interactions with the operational management to support Quality topics and interacting with Global QA

• Evaluates responses to inspection reports and performs follow-up with internal and external stakeholders to ensure resolution
  

Education / Qualifications/ Experience

• A minimum of a Bachelor’s Degree in Chemistry or Life Sciences; Master’s preferred

• Experience may be substituted for education

• 3 years’ in regulatory environment (GXP; experience in GLP/GCP roles preferred)

• Working knowledge of early drug development safety assessment expertise of industry quality systems/standards, preferred

• Ability to interpret applicable regulations/standards

• Experience in leading process improvement initiatives

• Ability to communicate and negotiate internal stakeholders effectively

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Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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