Quality Assurance/Computer System Validation Specialist II

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 Overview Provide quality assurance monitoring and audits of Charles River regulated computer systems to assure compliance with applicable regulations, corporate policies, and procedures. Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Communicate all identified compliance and quality risks to their supervisor. Independently provide quality assurance monitoring of simple computer systems to assure regulatory compliance, assisting with the development and/or review of validation deliverables. Provide recommendations for continuous improvement of the CSV/ IT compliance program. Assist in periodic assessments of IT regulated activities. Prepare audit reports for regulatory and procedural deficiencies and deviations. Review audit responses and assure deficiencies are addressed before systems are commissioned for use. Participate in customer or regulatory inspections and assist in coordinating responses and corrective/preventive actions with responsible departments. Participate in assessments of vendors of computerized systems, applications, and consulting services to assure that such services satisfy regulatory requirements and business objectives. Maintain an up-to-date knowledge of computer validation requirements. Perform all other related duties as assigned. 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, biomedical industry and/or information technology industry. Working knowledge of computer validation requirements in government regulations including and related multinational industry standards and requirements. 1-2 years of experience in auditing or quality assurance preferred. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. Other: Must be able to communicate with essential personnel from all business sectors, i.e., manufacturing and research models services, clinical services, preclinical services. Proficiency in computer-based word processing, spreadsheet and presentation applications required. Compensation Data The pay rate for this role is $90,000 - $100,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. About Biologics Testing Solutions With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand‑alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team. 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. Equal Employment Opportunity Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 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 View email address on click.appcast.io. 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 236266 #J-18808-Ljbffr Charles River Laboratories