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 2–8°C, -20°C, and -80°C 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.

Requirements:

• Bachelor’s 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.