QA / Quality Operations Consultant

Responsibilities

• Provide quality assurance oversight across manufacturing operations.
• Support shop floor quality activities within GMP-regulated environments.
• Partner with manufacturing teams to ensure compliance with quality standards and procedures.
• Aid in deviation investigations and corrective and preventive action (CAPA) activities.
• Contribute to inspection readiness programs and regulatory compliance initiatives.
• Support remediation and quality improvement efforts.
• Review manufacturing documentation and quality records.
• Identify compliance risks and escalate quality concerns as appropriate.
• Collaborate with cross-functional teams including Quality, Manufacturing, and Compliance functions.
• Assist in maintaining regulatory expectations across sterile and aseptic operations when applicable.

Requirements

• Experience within pharmaceutical, biotechnology, biologics, or related GMP manufacturing environments.
• Strong background in Quality Assurance or Quality Operations.
• Experience supporting manufacturing compliance programmes.
• Understanding of deviation management and CAPA processes.
• Knowledge of FDA and GMP regulatory requirements.
• Prior exposure to inspection readiness or remediation projects preferred.
• Experience in sterile manufacturing, aseptic processing, or fill-finish operations is highly desirable.
• Ability to work onsite in Greenville, NC on a rotational schedule.
• Strong communication, documentation, and stakeholder engagement skills.

Qualifications

The ideal candidate is a hands-on Quality Assurance or Quality Operations professional with experience supporting GMP manufacturing environments. They have worked closely with production teams on the shop floor, possess strong compliance knowledge, and are comfortable managing deviations, CAPAs, inspection readiness activities, and remediation programs. Experience within sterile, aseptic, biologics, or fill-finish manufacturing environments is especially valuable.