Global Computer Validation QA Specialist

Global Computer Validation QA Specialist Req ID #:  212758 Location: 

US For 75 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

⦁ Communicate all identified compliance and quality risks to his/her supervisor.

⦁ Provide quality assurance monitoring of projects to assure regulatory compliance of complex and 

critical computer systems at designated sites, assisting with the development, review and/or 

approval of validation deliverables.

⦁ Provide compliance support to Computer Validation QA managers on multisite and global 

computer systems, assisting with the development, review and/or approval of validation deliverables.

⦁ Develop, review and approve global policies, standards and procedures.

⦁ Assist in the development and maintenance of the computer validation training programs and 

present training in regulatory requirements for validation, maintenance, and operation of computer 

technologies. 

⦁ Assist with operational components, to develop and maintain an inventory of computerized 

systems used in regulated operations and their status relative to the Master Validation Process 

(MVP).

⦁ Review and approve validation plans, test results, and summary reports for regulatory 

compliance. Prepare audit reports for validation projects describing regulatory and procedural 

deficiencies and deviations. Review audit responses and assure deficiencies are addressed before 

systems are commissioned for use.

⦁ Work directly with the various staff and management on global internal audit-related activities 

including planning and oversight of IT internal audits, walkthroughs, testing, documentation of 

findings, issue remediation, follow-up, etc.

⦁ Maintain an up-to-date knowledge of computer validation requirements, practices and 

procedures, and inform other company staff of those requirements.

⦁ Provide compliance guidance to operational personnel on regulatory requirements for 

computerized system validation, development of user requirements specifications, testing strategies, 

and documentation requirements. 

⦁ Perform all other related duties as assigned.

  Job Qualifications ⦁ Education: Bachelor's degree (B.A./B.S.) or equivalent in a scientific discipline and/or computer 

related field.

⦁ Experience: 5+ 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, data integrity guidance and related 

multinational industry standards and requirements.

⦁ 2+ years experience in auditing or quality assurance

⦁ An equivalent combination of education and experience may be accepted as a satisfactory 

substitute for the specific education and experience listed above.

⦁ Certification/License: None.

⦁ Other: 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.)

PHYSICAL DEMANDS:

⦁ Must regularly operate a computer and occasionally operate other office productivity machinery 

such as a calculator, copy machine, and computer printer.

⦁ Must regularly communicate with employees/customers; must be able to exchange accurate 

information.

⦁ Must occasionally move about inside the office to access file cabinets, office machinery, etc.

WORK ENVIRONMENT:

⦁ General office working conditions; the noise level in the work environment is usually quiet.

Comments:

⦁ Requires occasional domestic and international travel.

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 20,000 employees within 110 facilities in over 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. 

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 86% of the drugs approved by the FDA in 2021.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.

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