Job Description

Quality Specialist – Compliance / C&Q

Wilson, NC | ONSITE | W2 Contract

Company: Global pharmaceutical company

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: This is an ONSITE role in Wilson, NC .

Employment Requirements:

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

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