Quality Compliance Specialist — GMP Audits & Documentation

Source One Technical Solutions, LLC; Wilson (NC); On-site; USD 120,000 - 140,000; Full time

Job summary

Source One Technical Solutions, LLC seeks a Quality Specialist to support a global pharmaceutical/biopharmaceutical organization in Wilson, NC. The role focuses on quality compliance, audit preparation, technical documentation, and regulated-industry requirements.

The ideal candidate has a Bachelor’s degree and 2–4 years in a regulated industry, with a strong background in Quality, Compliance, Maintenance, and Quality Control.

Qualifications

• Bachelor’s degree in a scientific, engineering, or related discipline.
• 2–4 years of experience in a regulated industry, preferably pharmaceutical/biopharmaceutical.
• Strong Quality Compliance/Technical Compliance background.
• Experience with audit preparation and inspection readiness.
• Knowledge of GMP/cGMP requirements and regulated practices.
• Knowledge of Maintenance and Quality Control functions.
• Experience reviewing/developing technical and departmental documentation.
• Familiarity with commissioning, qualification, validation, and related documentation.

Responsibilities

• Support site Quality and Compliance activities within a regulated pharmaceutical/biopharmaceutical environment.
• Provide Quality support for commissioning, qualification, validation, and related technical activities.
• Review technical and quality documentation for GMP/compliance.
• Draft and develop departmental documents, procedures, and work instructions.
• Support audit preparation and inspection-readiness activities.
• Collaborate with Maintenance, Quality Control, Engineering, Validation, Manufacturing, Operations, and other teams.

Skills

Quality compliance

Audit readiness

Technical writing

Regulated industry knowledge

Education

Bachelor's degree

Tools

SAP

Truvault

Job description

Source One Technical Solutions, LLC seeks a Quality Specialist to support a global pharmaceutical/biopharmaceutical organization in Wilson, NC. The role focuses on quality compliance, audit preparation, technical documentation, and regulated-industry requirements.

The ideal candidate has a Bachelor’s degree and 2–4 years in a regulated industry, with a strong background in Quality, Compliance, Maintenance, and Quality Control.