Inspection Team Lead, 1st shift

The Inspection Team Lead is a key role within INCOG BioPharma Operations, responsible for performing continuous monitoring of the inspection process, providing in-process daily review of executed batch records, and ensuring compliance with quality systems, policies, procedures, and cGMP practices.

Requirements

• Assist Inspection Supervisor to inspect and package syringes and vials
• Follow production and manufacturing procedures
• Inspect filled product container for cosmetic, particle, and integrity defects
• Perform reconciliation of finished inspected/packaged product and defects
• Assist in writing and implementing area’s process documents
• Operate equipment in compliance with SOPs
• Assure compliance with cGMP requirements
• Complete and review associated production records, logbooks, and forms
• Assist in performing and documenting Knapp and probability of detection studies
• Train new inspectors in accordance with inspector certification procedures
• Mentor new inspection/packaging associates
• Train new employees to perform manufacturing inventory transactions in the ERP system
• Assist other manufacturing functions as required
• Perform duties gowned in Grade C, D, and controlled non-classified cleanrooms
• Perform cleaning and sanitization activities as needed
• Collaborate and communicate with cross-functional teams
• Work flexible hours to ensure production facility coverage