Senior CSV Quality Assurance Specialist

RXinsider LTD.; Wayne (PA); On-site; USD 90,000 - 100,000; Full time

Job summary

Charles River is seeking a Quality Assurance professional to monitor regulated computer systems for regulatory compliance and to support audits. The role encompasses risk communication, system validation, and continuous improvement of the CSV/IT compliance program in a fast-paced environment.

The candidate will participate in assessments, prepare audit reports, and coordinate responses with affected departments, ensuring systems are compliant before use.

Qualifications

• Bachelor's degree in a scientific discipline and/or computer-related field.
• 2–4 years in pharmaceutical/biotech/IT industries.
• 1–2 years in auditing or quality assurance preferred.
• Equivalent combination of education and experience accepted.

Responsibilities

• Communicate identified compliance and quality risks to supervisor.
• Independently monitor quality assurance of simple computer systems for regulatory compliance.
• Contribute to continuous improvement of the CSV/IT compliance program.
• Assist in periodic assessments of IT regulated activities.
• Prepare audit reports and address deficiencies before system use.
• Assist in regulatory inspections and in coordinating responses and CAPAs.
• Assess vendor services for regulatory and business objectives.
• Maintain up-to-date knowledge of computer validation requirements.
• Perform other related duties as assigned.

Skills

Quality assurance

Regulatory compliance

Auditing

Computer systems validation

Regulatory knowledge

Education

Bachelor's degree in a scientific discipline or computer field

Job description

Charles River is seeking a Quality Assurance professional to monitor regulated computer systems for regulatory compliance and to support audits. The role encompasses risk communication, system validation, and continuous improvement of the CSV/IT compliance program in a fast-paced environment.

The candidate will participate in assessments, prepare audit reports, and coordinate responses with affected departments, ensuring systems are compliant before use.