Specialist, Safety Assessment Computer Validation Quality Assurance (Remote)

Req ID #:  215789

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


The Specialist SA Computer Validation QA is responsible for developing and executing software validation associated with Quality systems or data. The Specialist SA Computer Validation QA will develop, revise, and maintain Quality Systems (e.g. training, hardware/software validation, change control system, and archive) related to Master Control (Documentation Management System) to ensure compliance with industry standards and regulatory agency expectations.




  • Participate on Computer Validation teams to meet installation requirements pertaining to validation, maintenance and support of applications in use or planned as corporate computer/software projects
  • Develop, revise and maintain the Master Validation plans for corporate computer systems assuring compliance to Standard Operating Procedures, federal regulations, and industry standards
  • Provide validation review and perform assessment on current Computer Systems Validation
  • Review and approve SOPs related to Master Validation Plans for accuracy and correctness
  • Generate final Validation Reports for signature
  • Oversee and assist with validation activities as required
  • Assist with validation efforts of corporate projects
  • Develop, modify, maintain quality systems related to software validation at the corporate level and provide a standard template for software validation


Job Qualifications


  • Bachelor’s degree (B.A./B.S.) or equivalent in science or related discipline
  • 3-5 years related experience in scientific/regulated environment with at 1-3 years experience in validating computer systems
  • Knowledge of computer validation regulations including FDA 21 CFR Part 11, part 58, and 211 requirements
  • MASTERControl software knowledge preferred




  • While performing the duties of this job, the employee is frequently required to type at a computer
  • The employee must be able to lift and/or move up to 10 pounds
  • Specific vision abilities required by this job include close vision, distance vision, color vision, and the ability to adjust focus

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 Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.  Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. 


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 - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, 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.

Nearest Major Market: Boston

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