CSV & QA Specialist II - Computer Systems Compliance

Charles River Laboratories; Wayne (PA); On-site; USD 90,000 - 100,000; Full time

Job summary

Charles River Laboratories is seeking a Quality Assurance professional to monitor and audit regulated computer systems, ensuring compliance with applicable regulations and corporate policies. You will review validation deliverables and support inspections with cross-functional teams.

The role requires a Bachelor's degree in a scientific or computer-related field and 2–4 years in pharma/biotech or IT, with auditing experience preferred. Competitive salary and benefits.

Qualifications

• Bachelor's degree in a scientific discipline or computer-related field.
• 2–4 years of experience in pharma/biotech, biomedical, or IT.
• Working knowledge of computer validation requirements under regulations.
• 1–2 years of auditing or quality assurance preferred.
• Must communicate with personnel across manufacturing and research units.

Responsibilities

• Provide quality assurance monitoring and audits of regulated computer systems to ensure compliance with regulations and policies.
• Communicate identified compliance and quality risks to supervision.
• Develop or review validation deliverables and recommend continuous improvement of the CSV/ IT compliance program.
• Assist in periodic assessments of IT regulated activities and prepare audit reports.
• Support inspections and coordinate corrective actions with responsible departments.
• Maintain up-to-date knowledge of computer validation requirements.

Skills

Quality assurance

Auditing

Regulatory compliance

Computer validation

Education

Bachelor's degree in a scientific discipline

Job description

Charles River Laboratories is seeking a Quality Assurance professional to monitor and audit regulated computer systems, ensuring compliance with applicable regulations and corporate policies. You will review validation deliverables and support inspections with cross-functional teams.

The role requires a Bachelor's degree in a scientific or computer-related field and 2–4 years in pharma/biotech or IT, with auditing experience preferred. Competitive salary and benefits.