Inspection Technician (Internal Fill/Finish MFG)

Role Summary

Inspection Technician (Internal Fill/Finish MFG). Perform tasks for internal filled container inspection processes, including manual inspection of liquid and lyophilized vials and liquid syringes, and operation/maintenance of semi-automated and fully automated inspection equipment. Contribute to process proficiency, provide recommendations, and train colleagues.

Responsibilities

• Performs the visual inspection of liquid and lyophilized vials and liquid syringes using manual inspection booths and/or semi-auto inspection machines.
• Operates automatic inspection equipment.
• Performs line clearance and cleaning activities of inspection booths and semi-auto and auto inspection machines.
• Supports the load and unload of inspection equipment when not performing visual inspection activities.
• Reviews, edits, completes and revises completed batch records, logbooks and SOPs in accordance with cGMP standards and compliant with written procedure.
• Completes training and maintains required qualifications for visual inspection.
• Coordinates to ensure process areas are stocked with essential equipment and components and ensures equipment and process operational readiness.
• Reconciles components and product according to SOP and Batch Record requirements.
• Ensures all tasks are performed in a manner consistent with cGMP SOPs and safety standards.
• Participates in equipment start-up, commissioning and validation activities.
• Assists with troubleshooting in case of equipment failure.
• Gathers, trends, and analyzes process generated data
• Supports investigations associated with internal inspection activities.
• Documents all training.
• Assists with training of new employees as directed.
• Assists and contributes in all areas of visual inspection as needed.
• Travel (domestic and international) may be required to support new equipment purchases and/or training.
• Must be able to lift/push/pull at least 40lbs.

Qualifications

• Screened for visual acuity with required exams (near vision and color vision) as part of the role selection.
• Knowledge of cGMP manufacturing environment and familiarity with visual inspection of liquid and lyophilized products.
• Strong interpersonal, cross-cultural, communication, negotiation and problem-solving skills.
• Demonstrates confidence, emotional intelligence, ingenuity, creativity and resourcefulness.
• Ability to understand instructions and work toward goals individually or as part of a team.
• Ability to listen to team members and stakeholders and support a positive team environment.

Education

• Level I - HS diploma/GED/Leaving Cert; 0-2 yrs experience, college degree may be preferred.
• Level II - HS diploma/GED/Leaving Cert; 2+ yrs experience, college degree may be preferred.
• Level III - HS diploma/GED/Leaving Cert; 4+ yrs experience, college degree may be preferred.
• Level IV - HS diploma/GED/Leaving Cert; 6+ yrs experience, college degree may be preferred.
• Level determined based on qualifications relevant to the role.

Additional Requirements

• Travel (domestic and international) may be required to support equipment purchases or training.
• Must pass two visual acuity exams prior to start date: Near Vision Acuity (Jaeger Test) 20/20 and Color Vision (Ishihara Test) 14/14.