GMP Inspection Team Lead

Responsibilities

• Support the Inspection Supervisor by assisting in the daily oversight of 6–10 associates performing syringe and vial inspection and packaging
• Adhere to established production and manufacturing procedures
• Inspect filled product containers for cosmetic defects, particulates, and container integrity issues
• Perform reconciliation of inspected products, including tracking defects and yields
• Assist in the development, revision, and implementation of process documentation
• Operate manufacturing equipment in accordance with approved SOPs
• Ensure compliance with cGMP (current Good Manufacturing Practices) standards
• Accurately complete and review production records, logbooks, and related documentation
• Support and document Knapp and probability of detection (POD) studies
• Train and certify new inspectors following established procedures
• Mentor and guide new inspection team members
• Train employees on manufacturing inventory transactions within the ERP system
• Provide support across manufacturing functions, including Formulation, Fill, and Materials as needed
• Perform duties within Grade C, Grade D, and controlled non-classified cleanroom environments while properly gowned
• Execute cleaning and sanitization procedures as required
• Collaborate effectively with cross-functional teams to support production goals
• Maintain flexibility to support varying shifts and ensure adequate production coverage

• At least 2 years of GMP pharmaceutical experience, specifically in drug product inspection
• Ability to pass annual health, visual acuity, and color blindness assessments
• Prior experience in training or mentoring team members
• Previous leadership experience in a manufacturing environment