Drug Product Visual Inspection Technician I - Entry Level

About the role

This position is responsible for performing visual inspection of sterile filled containers (vials) in accordance with all applicable procedures, regulations, and safety directives. The primary job function is to ensure finished drug product vials manufactured by PCI are free of visible defects, which are culled through the visual inspection process to support patient safety and product quality.

Responsibilities

• Repetitive handling of sterile filled containers while primarily in a seated position, swirling and inverting containers and extending arm out in front of light source in order to identify product defects.
• Records production quantities and other applicable information with adherence to Good Documentation Practices.
• Applies a moderate level of math skills to include piece counting, time calculations, and product reconciliation.
• Follows written procedures and documents results in a neat and accurate manner according to GMP standards and other regulations.
• Performs daily cleaning of visual inspection and packaging areas in accordance with established procedures.
• Identifies and communicates product quality issues.
• Maintains attention to detail and quality while completing multiple or repetitive tasks and meeting product timelines.
• Effectively communicates both verbally and in writing with all levels.
• Maintains a high level of integrity while balancing all job responsibilities.
• Performs all job responsibilities in compliance with applicable regulations and standard operating procedures.

Requirements

• Previous employment within an FDA/USDA, GMP environment is desired.
• High school diploma or equivalent required.
• Basic computer skills are required.
• Basic verbal and written skills.
• Able to understand and follow instructions.
• Ability to read, understand, follow, and comply with technical and written documents (SOPs) written in English.
• Must be able to maintain visual qualifications: (20/20 vision corrected or uncorrected checked annually); ability to see all colors and the ability to visually discern product specifications across multiple products.
• Must be able to work while wearing PPE for all GMP areas for an entire shift (includes non-latex gloves, hair/beard covers, and lab coats).
• Detail-oriented and self-motivated.
• Commits to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in all work activities and in the delivery of PCI products and services.
• Honesty, integrity, respect, and courtesy with leadership and peers.
• Openly receives and implements feedback, resilient, able to move past mistakes; applies learning.