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Quality Specialist - Compliance / C&Q at Source One Technical Solutions Quality Specialist - Compliance / C&Q at Source One Technical Solutions in Wilson, North Carolina Posted in 13 days ago.

Type:

full-time 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