Process Improvement Specialist (Formulation/Filling)Accentuate Staffing • Morrisville, NC, US
Process Improvement Specialist (Formulation / Filling)
Accentuate Staffing • Morrisville, NC, US
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job_description.job_card.job_descriptionBachelor’s degree in a scientific or engineering field with 2+ years of sterile injectable manufacturing experience Minimum 1 year of technical writing experience (SOPs, deviations, batch records, etc.). Demonstrated leadership, training, and process improvement experience in a regulated cGMP environment. Strong understanding of cGMP, GDP, aseptic technique, and cleanroom behavior. Hands-on experience with compounding, filtration assemblies, isolator filling systems, and autoclaves. Excellent communication and interpersonal skills with the ability to train and mentor others effectively. Analytical thinker with strong problem-solving, documentation, and organizational skills.
Accentuate Staffing is assisting a growing pharmaceutical distributor in the Morrisville area who is hiring a Process Improvement Specialist (Formulation / Filling) to join their manufacturing team. This is a fantastic direct hire opportunity working on 1st shift, 8am-5pm, Monday-Friday.
Responsibilities :
- Partner with Manufacturing, Quality, Engineering, and Supply Chain teams to optimize processes in compounding, aseptic filling, and visual inspection.
- Serve as a subject matter expert (SME) for formulation / filling operations, providing on-the-floor technical support to maintain high-quality aseptic practices.
- Lead and support investigations for manufacturing deviations, identify root causes, and drive corrective and preventive actions (CAPAs).
- Develop, update, and maintain SOPs, batch documentation, risk assessments, and change controls to ensure process compliance and continuous improvement.
- Analyze production data and performance trends to identify process inefficiencies and recommend improvements to fill line capability, training, and documentation.
- Conduct operator training and qualification activities, reinforcing proper aseptic and cleanroom techniques in alignment with regulatory standards (Annex 1, USP, CFR 210 / 211, ICH).
- Support equipment qualification, material readiness, and sampling programs to ensure timely and compliant production.
- Participate in audits, client visits, and internal reviews, providing technical expertise and operational insights.
Requirements :
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Improvement Specialist • Morrisville, NC, US