Quality Remediation Contractor

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

About The Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position

Quality Remediation Contractor

Location

North Carolina

Duration

Long Term

Job Overview

We are seeking Quality Remediation Contractors with strong QA/Quality Systems experience in a regulated manufacturing environment. The ideal candidate will support Quality remediation activities, investigations, documentation, and backlog reduction while working within aggressive timelines.

Key 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.
• Prepare clear and accurate technical documentation.
• Support investigation and remediation backlog reduction.
• Manage high-volume Quality activities and meet required timelines.
• Collaborate with Quality, Manufacturing, Engineering, and cross-functional teams.
• Ensure compliance with applicable Quality and regulatory requirements.

Required Qualifications

• QA/Quality Systems experience in a regulated manufacturing environment.
• Experience with Quality remediation, investigations, CAPA, deviations, or related Quality Systems activities.
• Strong investigation, technical writing, and documentation skills.
• Ability to independently manage and close Quality activities.
• Experience handling high-volume work and aggressive remediation timelines.
• Pharmaceutical, biotechnology, or manufacturing experience preferred.
• Strong analytical, problem-solving, and communication skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.