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Qa Auditor - Small Molecular

2+ years
Not Disclosed
10 Jan. 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Quality Assurance Auditor, GLP/GCP
Location: Madison, WI (Onsite with potential Hybrid after training)

Labcorp is excited to offer an exceptional opportunity within the Quality Assurance Department for a Quality Assurance Auditor, GLP/GCP. If you have experience as an LCMS scientist, bioanalytical chemistry, and/or GLP/GCP auditing, this role might be the perfect fit for you!

Join us in our mission to help develop medicines that improve health and enhance lives. See below for the job details and benefits!


Position Overview

As a Quality Assurance Auditor, you will utilize your knowledge of LC/MS bioanalysis, FDA Guidance for Industry: Bioanalytical Method Validation, and GLP/GCP regulations to conduct audits, evaluate responses to inspection reports, and interact with internal and external stakeholders. This role ensures compliance with applicable quality regulations and supports operational management in maintaining high-quality standards.


Key Responsibilities

  • Conduct audits of bioanalytical validation and sample analysis according to GLP/GCP guidelines.
  • Review audit responses for completeness and follow up with stakeholders to ensure resolution.
  • Support liaison meetings with operational departments to represent the QA function.
  • Report on quality metrics and highlight trends for continuous improvement.
  • Peer review QA SOPs to ensure alignment with regulatory standards.
  • Ensure that all QA responsibilities, as indicated in controlled documents, are followed.

Minimum Required Qualifications

  • 2+ years of experience in a regulated environment, especially in GXP roles.
  • Knowledge of regulatory requirements and the ability to interpret and apply regulations to monitor compliance.
  • Strong problem-solving skills to identify critical quality issues.
  • Ability to clearly convey regulatory expectations to various teams.
  • Adaptability to a dynamic work environment.

Education/Qualifications

  • A Bachelor’s degree in Life Sciences is preferred (or equivalent experience).
  • Experience may be substituted for formal education.

Work Schedule

  • 8:00 AM - 5:00 PM
  • Location: 3301 Kinsman Blvd, Madison, WI
  • Potential for Hybrid after training and position understanding.

Benefits

Employees scheduled to work 20+ hours per week are eligible for a comprehensive benefits package, including:

  • Medical, Dental, and Vision Insurance
  • Life Insurance, STD/LTD
  • 401(k) Plan with company match
  • Paid Time Off (PTO) or Flexible Time Off (FTO)
  • Tuition Reimbursement
  • Employee Stock Purchase Plan

Join Labcorp's Quality Assurance team and be a part of something truly impactful!

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If you need assistance with the application process due to a disability, please visit our accessibility site or contact us for support.