Process Improvement Specialist (Formulation/Filling) Job at Accentuate Staffing, Morrisville, NC

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  • Accentuate Staffing
  • Morrisville, NC

Job Description

Accentuate Staffing is assisting a growing pharmaceutical manufacturer 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.

Qualifications

  • Bachelor’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.

Job Tags

Monday to Friday, Day shift,

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