Senior CSV/CSA Lead — GxP Validation & Compliance (Remote)

ACM Medical Labs, Inc; City of Rochester (NY); Remote; USD 130,000 - 155,000; Full time

Job summary

ACM Medical Labs, Inc is seeking a Senior CSV/CSA Specialist in Information Technology for remote work with East Coast preference. The role leads validation planning, execution, and lifecycle activities, partnering with IT and QA, mentoring junior staff, and ensuring systems comply with regulatory expectations.

Responsibilities include preparing validation documents, risk assessments, and change-impact analyses, while supporting audits, data integrity, and inspection readiness across complex

Qualifications

• 7+ years experience in CSV/CSA, GxP IT quality, validation, quality systems, software assurance, or regulated system lifecycle.

Responsibilities

• Lead validation planning for new systems, upgrades, and changes and coordinate across IT, QA, vendors and business stakeholders.
• Author, review, and approve validation deliverables including risk assessments, URS, specs, test protocols and traceability matrices.
• Ensure documentation is complete, traceable, and inspection-ready; oversee defect management and validation summaries.

Skills

CSV/CSA

GxP IT quality

Technical writing

Mentoring

Education

Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related field

Job description

ACM Medical Labs, Inc is seeking a Senior CSV/CSA Specialist in Information Technology for remote work with East Coast preference. The role leads validation planning, execution, and lifecycle activities, partnering with IT and QA, mentoring junior staff, and ensuring systems comply with regulatory expectations.

Responsibilities include preparing validation documents, risk assessments, and change-impact analyses, while supporting audits, data integrity, and inspection readiness across complex