Inspection Technician (Internal Fill/Finish)

Role Summary

2nd shift, Monday–Friday, 12:00 p.m.–8:30 p.m. Inspection Technician (Internal Fill/Finish) role focused on internal filled container inspection processes. You will manually inspect liquid and lyophilized vials and liquid syringes, operate semi-automated and fully automated inspection equipment, and contribute to process improvements. You will work both independently and as part of a team, developing proficiency across a range of procedures and training 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

• Pass two visual acuity exams prior to start: Near Vision Acuity (Jaeger) 20/20 (with or without corrective lenses) and Colorblindness Test (Ishihara) – 14/14.
• Level I – HS diploma/GED/Leaving Cert; 0–2 years experience; college degree may be preferred.
• Level II – HS diploma/GED/Leaving Cert; 2+ years experience; college degree may be preferred.
• Level III – HS diploma/GED/Leaving Cert; 4+ years experience; college degree may be preferred.
• Level IV – HS diploma/GED/Leaving Cert; 6+ years experience; college degree may be preferred.

Skills

• Strong attention to detail and visual inspection capabilities.
• Knowledge of cGMP manufacturing environment and familiarity with visual inspection of liquid and lyophilized products.
• Interpersonal, cross-cultural communication, negotiation and problem-solving skills.
• Confidence, high emotional IQ, 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’ needs and support a positive team environment.

Education

• HS diploma/GED/Leaving Cert required; college degree may be preferred depending on level.

Additional Requirements

• Travel (domestic and international) may be required to support new equipment purchases and/or training.
• Physical: must be able to lift/push/pull at least 40 lbs.