QA / Quality Operations Consultant

EPM Scientific; North Carolina; Hybrid; USD 74,000 - 129,000; Part time

Job summary

EPM Scientific seeks experienced quality professionals to support a major pharmaceutical manufacturing client in Greenville, North Carolina, providing onsite QA oversight within a GMP environment. The role focuses on remediation, CAPA, and inspection readiness across a two-week rotating onsite schedule with limited remote periods.

The ideal candidate has strong QA or quality operations background in GMP manufacturing, experience with deviation management and regulatory requirements, and

Qualifications

• Experience in pharmaceutical/biotech/biologics GMP manufacturing environments.
• Knowledge of FDA GMP regulatory requirements and quality systems.
• Experience with deviation investigations, CAPA, inspection readiness, and remediation projects.

Responsibilities

• Provide quality assurance oversight across manufacturing operations.
• Support shop floor quality activities within GMP environments.
• Collaborate with manufacturing and compliance teams to ensure quality standards.
• Assist with deviation investigations and CAPA activities.
• Contribute to inspection readiness programmes and regulatory compliance initiatives.
• Review manufacturing documentation and quality records to identify risks.

Skills

Quality Assurance

GMP

CAPA

Deviation management

FDA regulatory knowledge

Inspection readiness

Documentation

Stakeholder engagement

Cross-functional collaboration

Aseptic processing

Job description

We are seeking experienced quality professionals to support a major pharmaceutical manufacturing client in Greenville, North Carolina. This engagement focuses on strengthening quality oversight, manufacturing compliance, remediation activities, and inspection readiness efforts within a regulated GMP environment.

Consultants will join an established project team and provide onsite support for approximately 6 to 7 months. The role follows a two-week rotational onsite schedule with limited remote responsibilities during off-site periods.

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.
• Assist with deviation investigations and corrective and preventive action (CAPA) activities.
• Contribute to inspection readiness programmes and regulatory compliance initiatives.
• Support remediation and quality improvement efforts.
• Review manufacturing documentation and quality records.
• Identify compliance risks and elevate 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.

Ideal Candidate Profile

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 programmes. Experience within sterile, aseptic, biologics, or fill-finish manufacturing environments is especially valuable.