Quality Specialist – Compliance / C&Q

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

Contract duration: 18 months with a likely extension

Hourly Rate: $62.51 per hour / W2

We are seeking a Quality Specialist to support a global pharmaceutical/biopharmaceutical organization in Wilson, NC. This position is focused heavily on quality compliance, audit preparation, technical documentation, and regulated-industry requirements.

The ideal candidate will have a Bachelor’s degree, 2–4 years of experience in a regulated industry, and a strong technical understanding of Quality, Compliance, Maintenance, and Quality Control environments.

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 compliance with applicable GMP and site requirements.
• Assist other departments with drafting and developing departmental documents, procedures, work instructions, and related documentation.
• Support audit preparation and ongoing inspection-readiness activities.
• Partner with Maintenance, Quality Control, Engineering, Validation, Manufacturing, Operations, and other functional teams.
• Apply knowledge of regulated-industry requirements to support compliant processes and documentation.
• Review documentation associated with equipment, utilities, systems, and qualification activities.
• Support quality systems and documentation processes while ensuring adherence to established procedures and requirements.
• Identify compliance concerns and use sound judgment to determine appropriate actions.
• Adapt to changing priorities and work effectively across multiple functional teams.

Required Qualifications

• Bachelor’s degree required in a scientific, engineering, or related discipline.
• 2–4 years of experience in a regulated industry, preferably pharmaceutical, biopharmaceutical, biotech, or a similar GMP environment.
• Strong Quality Compliance / Technical Compliance background.
• Experience with audit preparation and inspection readiness.
• Knowledge of GMP/cGMP requirements and regulated-industry practices.
• Knowledge of Maintenance and Quality Control functions.
• Experience reviewing and/or developing technical and departmental documentation.
• Familiarity with commissioning, qualification, validation, and associated documentation.
• Strong technical writing and documentation skills.
• Ability to make decisions, adapt to changing priorities, and work independently.
• Flexible, highly motivated, and eager to learn.

Preferred / Plus

• SAP experience is a HUGE PLUS.
• Truvault experience is helpful.
• Experience with FDA/EMA/ICH/GMP-regulated environments.
• Familiarity with URS, FAT, SAT, IQ, OQ, PQ and validation lifecycle documentation.
• Experience supporting audit/inspection preparation.

Important:

Important: This is an ONSITE role in Wilson, NC.

Employment Requirements:

• W2 only
• No C2C
• Must be a U.S. Citizen or Permanent Resident
• Minimum 2–4 years of relevant experience