Covance

GMP Quality Assurance Officer , Pharmaceutical Research

Job Location(s) US-IN-Greenfield
Job Number
2017-14120
Job Category
Quality Assurance
Position Type
Full-Time

Job Overview

GMP Quality Assurance Officer

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 GMP-regulated environment?

 

 

If you are looking to grow your career in pharmaceutical QA, consider joining Covance as a GMP Quality Assurance Officer. In this position you will support the implementation of the global GMP quality management system, ensuring requirement are met as you: 

 

 

  • Monitor, analyze, and report site metrics and data trends related to the performance of the site quality management system
  • Support GMP analysis that support early phase to commercial large molecules for pharmaceutical research
  • Influence and consult with internal BioCMC operations
  • Review and approve site quality documents to ensure compliance with GMP, SOPs, and other applicable quality standards
  • Support the supplier qualification program by participating in third party audits
  • Provide regulatory approval of study related documentation
  • Support the GMP QA internal audit program by hosting, reporting and following up on system, process, and facility audits
  • Lead and approve investigations into the cause and resolution of quality defects
  • Participate in the development and delivery of GMP training
  • Provide advice and guidance and independent review to the site on aspects of quality and GMP compliance
  • Participate as tour guide during Client and Regulatory Authority inspections, including FDA, EU, and HMRA
  • Contribute to continual improvement initiatives aimed at improving the efficiency and effectiveness of GMP operations

 

 

This position is office-based in Greenfield, 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 GMP QA Officers 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

 

 

GMP QA Officers are the most successful at Covance with:

 

  • A Bachelor’s degree, preferably in science or a related field with a preference for an advanced degree
  • At least 5 years of experience in a GMP-regulated environment with at least three years of QA experience
  • In depth knowledge of current regulatory guidelines including GMP and 21 CFR Part 210/211
  • A general awareness of industry quality systems and standards including ICHQ9 and ICHQ10
  • 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. 

Education/Qualifications

  • A Bachelor’s degree, preferably in science or a related field with a preference for an advanced degree

Experience

  • At least 5 years of experience in a GMP-regulated environment with at least three years of QA experience
  • In depth knowledge of current regulatory guidelines including GMP and 21 CFR Part 210/211
  • A general awareness of industry quality systems and standards including ICHQ9 and ICHQ10
  • 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

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