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QA Consultant at Valspec - ApplyBlast

QA Consultant

Valspec

5 months ago

Remote

Contract

Senior

0 applicants

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About this role

Automation QA Engineer at Valspec supports automation quality assurance activities in a GMP-regulated pharmaceutical manufacturing environment, focusing on commissioning, qualification, validation, and lifecycle documentation for automation systems.

Responsibilities

Provide QA oversight and support for automation-related qualification and validation activities
Review and approve validation lifecycle documentation including IQ/OQ/PQ protocols and reports, risk assessments, traceability matrices, change controls, and deviations and CAPAs
Support automation systems operating within GMP manufacturing environments
Ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11 requirements
Partner with Automation, CQV, CSV, Manufacturing, and Quality teams to ensure compliant execution of project deliverables

Skills

Qualifications

Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field3+ years of experience in Automation QA, CSV, CQV, or Validation within the pharmaceutical, biotech, or regulated manufacturing industryStrong understanding of GMP compliance and validation lifecycle principlesExperience reviewing and approving GMP documentationFamiliarity with data integrity and 21 CFR Part 11 requirements

About Valspec

valspec.net

Headquarters

Royersford, Pennsylvania, United States

Company Size

51-200 employees

View Profile

Valspec is a digital lifecycle services company for the life sciences industry, specializing in end-to-end implementation, qualification, and validation of enterprise software, IT/OT infrastructure, and manufacturing systems. With 25 years of experience, they offer services spanning CSV/CSA, CQV, data governance and integrity, eVLM implementation, and AI-driven digital solutions. Valspec helps pharmaceutical, biotech, and related clients achieve regulatory compliance and inspection readiness across the full system lifecycle.