Specialist, Safety Assessment Computer Validation Quality Assurance

Specialist, Safety Assessment Computer Validation Quality Assurance Req ID #:  124271 Location: 

Wilmington, MA, US, 01887 At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families. 

Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career. 

As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   

  Job Summary

Provide quality assurance monitoring and audits of Safety Assessment (SA) Charles River computer validation projects to assure compliance with applicable regulations, corporate policies, and procedures.  Assist in periodic assessments of SA IT regulated activities. 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 and/or review of validation deliverables. Provide compliance support to SA Computer Validation on multisite and global computer systems, assisting with the development and/or review of validation deliverables. 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.  Monitor compliance of the SA multisite systems including the inventory of computerized systems used in regulated operations and their status relative to the Master Validation Process (MVP). Audit validation packages 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 Participate in vendor assessments to include but not limited to: software, GLP, GMP, and IT. Assist in periodic assessments of SA IT regulated activities. Job Qualifications Education: Bachelor's degree (B.A./B.S.) or equivalent in a scientific discipline and/or computer related field. Experience : 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 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.)

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

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 90 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 billion.

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.

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.

Nearest Major Market: Boston

Job Segment: Biotech, Developer, Safety, Quality Assurance, Science, Technology, Service, Research