QMS Documentation & Compliance Specialist

Planet Pharma; Warwick (RI); On-site; USD 52,000 - 65,000; Full time

Job summary

Planet Pharma is seeking a Temporary QMS Documentation Remediation Specialist to provide dedicated support for reviewing, remediating, harmonizing, and cleansing QMS documentation within the Surgery business unit. The role requires independent assessment of procedures, forms, and records to identify gaps and opportunities for simplification and standardization.

The ideal candidate will have hands-on experience in GMP-compliant pharmaceutical and medical device quality systems, with strong

Qualifications

• B.S. degree in Engineering/Science or related discipline.
• Minimum 5 years of experience in FDA-regulated industries.
• Experience in Pharmaceutical GMP and Medical Device Quality Systems (QSR/QMSR and ISO 13485).
• Direct experience supporting combination products strongly preferred.
• Experience authoring, revising, and remediating controlled quality system documentation.
• Experience working within electronic document management systems (e.g., Veeva, MasterControl, TrackWise, ComplianceWire, Teamcenter, Documentum, Agile, etc.).
• ASQ certification (CQE, CQA, CMQ/OE) preferred.

Responsibilities

• Review and assess assigned QMS documents.
• Document findings and recommended actions.
• Update and revise documents as directed.
• Maintain remediation trackers and metrics.
• Support closure of documentation-related remediation activities.
• Conduct comprehensive reviews of controlled QMS documentation (policies, manuals, SOPs, work instructions, forms, quality plans, validation procedures).
• Identify gaps, redundancies, inconsistencies, and opportunities for standardization.

Skills

Technical writing

GMP knowledge

Regulatory interpretation

Attention to detail

Cross-functional collaboration

Education

B.S. in Engineering/Science

Tools

Veeva

MasterControl

TrackWise

ComplianceWire

Teamcenter

Documentum

Agile

Job description

Planet Pharma is seeking a Temporary QMS Documentation Remediation Specialist to provide dedicated support for reviewing, remediating, harmonizing, and cleansing QMS documentation within the Surgery business unit. The role requires independent assessment of procedures, forms, and records to identify gaps and opportunities for simplification and standardization.

The ideal candidate will have hands-on experience in GMP-compliant pharmaceutical and medical device quality systems, with strong