Quality Remediation Contractor
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.
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. Location: North Carolina. Duration: Long Term.
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.