GMP Operations Specialist

CAI • Raleigh, NC

4d

About The Position

The GMP Operations Specialist is an experienced pharmaceutical manufacturing professional who helps clients improve operational performance, readiness, and execution in GMP-regulated environments. The role evaluates manufacturing operations, organizational readiness, and business processes to identify performance gaps, operational risks, and improvement opportunities. Working with cross-functional teams, the specialist develops and implements practical solutions to improve productivity, compliance, quality, throughput, and operational effectiveness. The work includes operational assessments, process optimization, training, deviation and CAPA support, risk mitigation, and readiness planning, using analytical, communication, and change management skills to support sustainable operational excellence.

The specialist consults with pharmaceutical clients on aseptic operations and serves as a trusted advisor and subject matter expert. The role requires at least six years of pharmaceutical manufacturing experience focused on aseptic operations, and willingness to travel to client sites as needed. The stated average base salary range is $90,000–$110,000, not including benefits.

Requirements

• Bachelor’s degree in a scientific discipline or an equivalent combination of education and experience.
• At least 6 years of pharmaceutical manufacturing experience, focused on aseptic operations.
• Expertise in aseptic techniques, cleanroom operations, and gowning procedures.
• Comprehensive understanding of cGMP regulations and regulatory requirements for aseptic manufacturing.
• Strong analytical and problem-solving skills, including the ability to assess complex situations and develop practical solutions.
• Excellent communication, presentation, and interpersonal skills, with the ability to engage and influence clients at all levels.
• Ability to manage multiple projects, prioritize tasks, and meet deadlines.
• Willingness to travel to client sites as needed.

Nice To Haves

• Certification in Aseptic Processing or relevant professional credentials.

Responsibilities

• Assess clients’ aseptic operations to identify improvement areas, compliance gaps, and efficiency opportunities.
• Develop and implement tailored strategies, protocols, and best practices for aseptic operations, including cleanroom design, gowning procedures, aseptic filling processes, and environmental monitoring.
• Evaluate client facilities, equipment, and processes for alignment with cGMP regulations and industry standards.
• Lead training sessions and workshops on aseptic techniques, cleanroom behavior, and regulatory compliance.
• Guide and support media fill studies, airflow pattern studies, interventions, gowning qualification assessments, and environmental monitoring activities.
• Collaborate with client stakeholders, including Quality Assurance, Quality Control, Engineering, and Manufacturing, to implement improvements and address compliance issues.
• Assist with investigation and resolution of aseptic-related deviations and recommend corrective and preventive actions.
• Stay current with industry trends, regulatory updates, and technological advances in aseptic manufacturing.
• Prepare reports, documentation, and presentations summarizing findings, recommendations, and implementation plans for clients and internal stakeholders.
• Build client relationships and foster long-term partnerships as a trusted advisor and subject matter expert.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior