QA / Quality Operations Consultant
Overview
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 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.
Ideal Candidate Profile
FAQs
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