Visual Inspection Technician - Lead

PCI Pharma Services•Madison, WI

About The Position

The Lead Visual Inspection Technician performs 100% manual visual inspection, labeling, and packaging of sterile-filled containers (vials) across multiple sites, following applicable procedures, regulations, and safety directives. The role supports Visual Inspection, Packaging, and Labeling with minimal to no supervision while maintaining precise GMP documentation and attention to detail and quality. The Lead serves as a link between team members across two manufacturing sites and Visual Inspection Management. The role models integrity and professionalism, communicates new policies and procedures, organizes and delegates work, supports team performance, and helps maintain healthy communication between workers and management. The Lead also contributes to investigations, document changes, training, metrics, qualification test kits, protocol execution, and process improvements.

Requirements

  • Ability to perform the essential duties satisfactorily.
  • Strong people skills and ability to organize team members and delegate tasks.
  • Knowledge sufficient to guide team members and earn their respect through sound judgment.
  • Responsible, dependable, self-motivated, and proactive approach, including providing suggestions for improvement.
  • Ability to maintain attention to detail and quality while completing multiple or repetitive tasks and meeting product timelines.
  • Physical capability to perform the duties listed, with or without reasonable accommodation.

Responsibilities

  • Perform 100% manual visual inspection, labeling, and packaging of sterile-filled vials across multiple sites.
  • Perform job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practices.
  • Support Visual Inspection, Packaging, and Labeling with minimal to no supervision.
  • Follow written procedures and document results neatly and precisely according to GMP standards and other regulations.
  • Monitor workers during production activities to ensure adherence to ethics and safety procedures.
  • Motivate workers to increase production while maintaining high production standards.
  • Collaborate with management to create work schedules and ensure they are within process capabilities.
  • Initiate Quality System Event investigations, including Event Reports, Deviations, and CAPAs, and work with management to determine probable root causes.
  • Perform document changes within the Master Control system.
  • Review protocols and manufacturing batch records and provide insight for process improvements.
  • Support development and tracking of KPIs relating to defect rate, inspection throughput, on-time delivery, and right-first-time performance.
  • Train new employees on visual inspection requirements for liquid and lyophilized final vial product.
  • Support management in developing and maintaining visual inspection qualification test kits, as applicable.
  • Assist management with executing protocols and additional projects in a timely manner.
  • Stay current on industry trends and inform team members of new policies or procedures.
  • Serve as a guide and communication link between workers and management; answer questions, offer insight, and organize responsibilities.
  • Identify potential issues using knowledge and experience and work with management to resolve them.
  • Support team members' overall performance toward meeting group objectives.
  • Maintain attention to detail and quality while completing multiple or repetitive tasks and meeting product timelines.
  • Perform other duties as assigned or as business needs require.
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