Quality Remediation Contractor - Fast-Paced QA & CAPA Expert

Stark Pharma Solutions Inc; Cary (NC); On-site; USD 62,000 - 103,000; Full time

Job summary

Stark Pharma Solutions Inc. seeks Quality Remediation Contractors with strong QA/Quality Systems experience in a regulated manufacturing environment.

You will support remediation activities, investigations, and backlog reduction while working under aggressive timelines. Responsibilities include handling CAPA, deviations, investigations, change control, and QMS/eQMS tasks, collaborating with Quality, Manufacturing, and Engineering teams to ensure compliance and timely closure of quality

Qualifications

• Experience with QA/Quality Systems in a regulated manufacturing environment.
• Experience handling investigations, CAPA, deviations, or related quality activities.
• Strong technical writing and documentation skills.
• Ability to independently manage and close quality activities within aggressive timelines.
• Pharmaceutical, biotechnology, or manufacturing background preferred.

Responsibilities

• Support Quality remediation and investigation activities.
• Manage and close quality activities independently.
• Handle CAPA, deviations, investigations, root cause analysis, complaints, audits, change control, validation and QMS/eQMS activities.

Skills

QA/QMS

Investigations

Documentation

CAPA/Deviations

Root Cause

Regulatory

Communication

Job description

Stark Pharma Solutions Inc. seeks Quality Remediation Contractors with strong QA/Quality Systems experience in a regulated manufacturing environment.

You will support remediation activities, investigations, and backlog reduction while working under aggressive timelines. Responsibilities include handling CAPA, deviations, investigations, change control, and QMS/eQMS tasks, collaborating with Quality, Manufacturing, and Engineering teams to ensure compliance and timely closure of quality