Hiring: Quality Assurance CSV Specialist II - Onsite role Company: Charles River Laboratories Location: Wayne, PA Job Posted Time: 2026-09-16 13:23:58 Employment Type: Contract Target Skills & Keywords : Quality Assurance, Regulatory Compliance About the job 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. •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. •2 years of experience in auditing or quality assurance preferred. Required Skills: •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. Qualifications: •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. •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. •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. Compensation: •$90,000 - $100,000 / year •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!