Accentuate Staffing
Quality Inspector/Training Coordinator (Morrisville)
Accentuate Staffing, Morrisville, North Carolina, United States, 27560
Accentuate Staffing is assisting a growing pharmaceutical distributor in the Morrisville area who is hiring a Quality Inspector/Training Coordinator to join their manufacturing team. This is a fantastic direct hire opportunity working on 1st shift, 8am-
5pm, Monday-Friday.
Responsibilities Oversee visual inspection activities for vials, syringes, and lyophilized products, ensuring all materials meet strict quality and appearance standards. Develop and maintain SOPs, batch records, and risk assessments, ensuring alignment with cGMP and regulatory requirements. Lead investigations and CAPAs for manufacturing deviations; identify root causes and implement effective corrective actions. Serve as a training coordinator, tracking technician qualifications, scheduling training sessions, and ensuring consistent competency across all shifts. Design and facilitate hands-on training programs for compounding, filling, and visual inspection operations, coordinating materials and resources as needed. Support ongoing process optimization by identifying procedural inefficiencies and driving improvements in visual inspection techniques, defect library management, and documentation accuracy. Partner with cross-functional teams in Manufacturing, Quality, Engineering, and Supply Chain to maintain readiness and compliance for production operations. Utilize SAP and other systems for batch documentation, material tracking, and finished product inventory management. Assist with sample management, storage monitoring, and resolution of temperature excursions for 28C, -20C, and -80C stored materials. Provide technical floor support during critical manufacturing and inspection activities, ensuring adherence to aseptic and cleanroom standards. Participate in internal and external audits, offering subject matter expertise on visual inspection practices and training programs.
Qualifications & Skills Bachelors degree in a related field with 2+ years of sterile injectable manufacturing experience Minimum 1 year of experience in technical writing (SOPs, deviations, or batch records). Proven leadership and training coordination experience in a regulated manufacturing environment. Strong understanding of cGMP, GDP, and aseptic processing principles. Hands-on experience with light inspection booths, light meters, TAPPI charts, and other visual inspection equipment preferred. Familiarity with autoclaves, filter integrity testers, mixing systems, and single-use assemblies is a plus. Excellent communication, documentation, and interpersonal skills, with the ability to train and mentor effectively. High attention to detail with a structured approach to troubleshooting, root cause analysis, and process control. Proficiency in Microsoft Office and electronic documentation systems; SAP experience preferred.
Responsibilities Oversee visual inspection activities for vials, syringes, and lyophilized products, ensuring all materials meet strict quality and appearance standards. Develop and maintain SOPs, batch records, and risk assessments, ensuring alignment with cGMP and regulatory requirements. Lead investigations and CAPAs for manufacturing deviations; identify root causes and implement effective corrective actions. Serve as a training coordinator, tracking technician qualifications, scheduling training sessions, and ensuring consistent competency across all shifts. Design and facilitate hands-on training programs for compounding, filling, and visual inspection operations, coordinating materials and resources as needed. Support ongoing process optimization by identifying procedural inefficiencies and driving improvements in visual inspection techniques, defect library management, and documentation accuracy. Partner with cross-functional teams in Manufacturing, Quality, Engineering, and Supply Chain to maintain readiness and compliance for production operations. Utilize SAP and other systems for batch documentation, material tracking, and finished product inventory management. Assist with sample management, storage monitoring, and resolution of temperature excursions for 28C, -20C, and -80C stored materials. Provide technical floor support during critical manufacturing and inspection activities, ensuring adherence to aseptic and cleanroom standards. Participate in internal and external audits, offering subject matter expertise on visual inspection practices and training programs.
Qualifications & Skills Bachelors degree in a related field with 2+ years of sterile injectable manufacturing experience Minimum 1 year of experience in technical writing (SOPs, deviations, or batch records). Proven leadership and training coordination experience in a regulated manufacturing environment. Strong understanding of cGMP, GDP, and aseptic processing principles. Hands-on experience with light inspection booths, light meters, TAPPI charts, and other visual inspection equipment preferred. Familiarity with autoclaves, filter integrity testers, mixing systems, and single-use assemblies is a plus. Excellent communication, documentation, and interpersonal skills, with the ability to train and mentor effectively. High attention to detail with a structured approach to troubleshooting, root cause analysis, and process control. Proficiency in Microsoft Office and electronic documentation systems; SAP experience preferred.