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.

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

• 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.

• 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.

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…