Senior GLP Quality Assurance Auditor

Covance Inc Located in: Indianapolis,  Indiana
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Covance Inc Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Senior GLP Quality Assurance Auditor

Grow your career with a global leader

 

Do you appreciate the importance of paying attention to details? Are you an organized person who can work independently and drive data integrity? Can you ensure compliance to quality standards across our global GCP/GLP-regulated environment?

 

 

If you are looking to grow your career in pharmaceutical QA, consider joining Covance as a Senior Quality Assurance Auditor. In this position you will perform protocol, data, and report review and in-lab inspections to verify compliance with applicable SOPs and regulatory requirements (GCP/GLP) as you: 

 

  • Audit bio-analytical studies that support both large and small molecules
  • Consult with operations to ensure alignment with current regulations
  • Implement new or updated regulations within the Covance quality system
  • Evaluate responses to inspection reports, ensuring resolution
  • Host client and regulatory visits and QMS audits from introduction to debrief
  • Prepare and deliver quality training in regulatory and quality
  • Lead process improvement and harmonization efforts that promote best practices

 

This position is office-based in Indianapolis, IN.

 

 

Working and thriving at Covance

 

As part of the global QA team, you’ll work in our fast-paced environment and contribute to our client-centric solutions in one the world's largest and most comprehensive drug development services companies.

 

 

We offer a competitive compensation package with medical and dental insurance, tuition reimbursement, a 401(k) plan with a generous company match, along with short and long-term disability and life insurance.

 

Why Senior QA Auditors choose to work at Covance

 

  • Join a global company with many opportunities for career growth
  • Make a direct impact in healthcare and the lives of patients
  • Partner with and learn from inspiring colleagues and industry leaders

 

What we’re looking for

 

 

Senior QA Auditors are the most successful at Covance with:

 

  • A Bachelor’s degree, preferably in science or a related field
  • At least 5 years of experience in a GCP/GLP-regulated environment with at least one year of auditing experience
  • Working knowledge of current regulatory guidelines including GCP/GLP and 21 CFR Part 58 and a general knowledge of ICH GCP compliance
  • Strong working knowledge of FDA Guidance for Industry, Bioanalytical Method Validation (LC/MS-MS preferred), and experience with Watson LIMs and Analyst software preferred
  • Strong drive for process optimization and data integrity
  • Excellent communication and interpersonal skills with the ability to influence others with impact and excellent attention to detail
  • Outstanding experience with client satisfaction and problem solving solutions
  • Experience working in the CRO/Pharma industry highly preferred

 

Get to know Covance

 

 

Beyond excellent compensation and benefits as a Senior Quality Assurance Officer, joining Covance opens the door to many career opportunities. Learn about what’s possible for your career when a company truly invests in you at http://careers.covance.com/possibilities.html

 

 

Why Covance

 

 

At Covance, it’s our people that make us great – it’s what our clients, our partners and, most importantly, what our employees say. Here, you’ll have the opportunity to lead exceptional people with diverse viewpoints. You’ll discover your own extraordinary potential as you drive strategy and build an even stronger organization with industry leaders from early development to the clinic and beyond. Through your everyday work and an energized purpose, you’ll advance science and impact the lives of countless individuals.

 

Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients, our team—and you.

 

Ready to join us? Let’s get started. 

  • A Bachelor’s degree, preferably in science or a related field
  • At least 5 years of experience in a GCP/GLP-regulated environment with at least one year of auditing experience
  • Working knowledge of current regulatory guidelines including GCP/GLP and 21 CFR Part 58 and a general knowledge of ICH GCP compliance
  • Strong working knowledge of FDA Guidance for Industry, Bioanalytical Method Validation (LC/MS-MS preferred), and experience with Watson LIMs and Analyst software preferred
  • Strong drive for process optimization and data integrity
  • Excellent communication and interpersonal skills with the ability to influence others with impact and excellent attention to detail
  • Outstanding experience with client satisfaction and problem solving solutions
  • Experience working in the CRO/Pharma industry highly preferred
Not ready to apply? Connect with us to join our talent community.

CRITICAL REQUIREMENTS

COMPANY INFORMATION

Covance Inc. is proud to be the only drug development company with a full range of research and development services—from lead optimization, to commercialization and life cycle management. Covance, headquartered in Princeton, NJ, is the drug development business of LabCorp with global operations in more than 30 countries.

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Quality
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: