GLP/GCP Quality Auditor | Compliance & Audit Lead

Labcorp; Indianapolis (IN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life

STD/LTD

401(k)

PTO/FTO

Tuition Reimbursement

Employee Stock Purchase Plan

401(k) for part-time

Job summary

Labcorp in Indianapolis, IN is seeking a Quality Auditor to join our Quality Assurance team. The role focuses on ensuring clinical research laboratory operations comply with GLP/GCP, ISO 15189, ISO 13485 and CAP, and supports audits and regulatory inspections.

The ideal candidate holds a Bachelor's in a science field, plus 6 years in a regulatory GLP/GCP environment and 2 years of auditing, with postgraduate MSc or equivalent preferred.

Qualifications

• Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline.
• 6 years in regulatory GLP/GCP environment.
• 2 years of Auditing experience.
• Postgraduate degree (MSC or equivalent) in science or management related discipline.

Responsibilities

• Conduct audits as identified on the audit activity table.
• Contributes to global QA policies on interpretation/ application of regulations.
• Provide subject matter expertise to projects; Support CAPA plan creation.
• Hosts external audits/inspections e.g. regulatory inspections, strategic clients; Assists with the facilitation of audit responses.
• Supports the QA-to-QA relationship with key client(s).
• Delivery of training in performance of audits (basic, intermediate, complex).
• Participate in global Quality initiatives aimed at improving compliance/efficiency of the QA organization.
• Supports the reporting of quality metrics and implementation of corrective actions.

Skills

Regulatory compliance

Audit experience

GCP/GLP knowledge

Interpersonal skills

Documentation

Education

Bachelor’s Degree in Pharmacy, Chemistry or Biology

Postgraduate degree (MSC or equivalent) in science/management

Job description

Labcorp in Indianapolis, IN is seeking a Quality Auditor to join our Quality Assurance team. The role focuses on ensuring clinical research laboratory operations comply with GLP/GCP, ISO 15189, ISO 13485 and CAP, and supports audits and regulatory inspections.

The ideal candidate holds a Bachelor's in a science field, plus 6 years in a regulatory GLP/GCP environment and 2 years of auditing, with postgraduate MSc or equivalent preferred.