Specialist, Global Computer Validation Quality Assurance (Remote)

Req ID #:  69151
Location: 

US

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Job Summary

 

We are seeking a Specialist, Global Computer Validation Quality Assurance   for our Global Quality Systems Team.  This position can be located at any of our US sites or remote.

 

This position will be responsible for providing quality assurance monitoring and audits for multi-business units across Charles River computer validation projects globally to assure compliance with applicable regulations, corporate policies, and procedures.  Assist in periodic assessments of globally controlled IT regulated activities.  Assist in data integrity monitoring and improvement initiatives. 

 

The following are the minimum requirements related to the Specialist, Global Computer Validation Quality Assurance position:

 

  • Bachelor's degree (B.A./B.S.) or equivalent in a scientific discipline and/or computer related field.
  • 2-4 years related experience in a pharmaceutical, biotechnology and/or biomedical industry.  Working knowledge of computer validation requirements in government regulations including FDA 21 CFR parts 11, 58, 211, and 820, OECDs and related multinational industry standards and requirements.
  • 1-2 years experience in auditing or quality assurance.
  • Must be able to communicate with essential personnel from all business sectors, i.e., manufacturing and research models services, clinical services, preclinical services.  Demonstrated leadership skills required.  Proficiency in computer-based word processing, spreadsheet and presentation applications required.   Active membership of a professional organization specific to quality assurance and federal regulations (e.g. GLP, GMP, etc.)
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

 

 

About Corporate Functions 

The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.

 

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

 

With over 17,000 employees within 80 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62.

 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.

 

Equal Employment Opportunity 

 

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet