QMS Documentation Remediation Specialist

Lancesoft; Warwick (RI); On-site; USD 90,000 - 130,000; Full time

Job summary

Lancesoft seeks a Temporary QMS Documentation Remediation Specialist to review, remediate, harmonize, and clean up QMS documentation for the Client Surgery business unit. The role requires hands-on experience with GMP GMP, QSR/QMSR, ISO 13485 and related regulatory standards.

The contractor will assess controlled documents, update procedures, maintain trackers, and support audit readiness. Strong collaboration with Quality, Regulatory Affairs, Operations, and SMEs is essential.

Qualifications

• BS degree in engineering/science or related
• Minimum 5 years in FDA-regulated industries (pharma/medical device)
• Experience with pharmaceutical GMP and medical device quality systems
• Experience authoring, revising, remediating controlled quality system docs
• Experience with electronic document management systems (e.g., Veeva, MasterControl)

Responsibilities

• Review and assess assigned QMS documents for compliance and clarity
• Document findings and recommended actions
• Update and revise documents as directed
• Maintain remediation trackers and metrics
• Support closure of documentation remediation activities
• Assist with audits and inspection readiness

Skills

cGMP

QMSR

ISO 13485

ICH Q10

Risk management

Technical writing

Education

B.S. Degree in Engineering/Science or related discipline

Minimum 5 years of FDA-regulated industry experience

ASQ certification (CQE/CQA/CMQ/OE) preferred

Tools

Veeva

MasterControl

TrackWise

ComplianceWire

Teamcenter

Documentum

Agile

Job description

Lancesoft seeks a Temporary QMS Documentation Remediation Specialist to review, remediate, harmonize, and clean up QMS documentation for the Client Surgery business unit. The role requires hands-on experience with GMP GMP, QSR/QMSR, ISO 13485 and related regulatory standards.

The contractor will assess controlled documents, update procedures, maintain trackers, and support audit readiness. Strong collaboration with Quality, Regulatory Affairs, Operations, and SMEs is essential.