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This position is responsible for performing visual inspection of sterile filled containers (vials) in accordance with all applicable procedures, regulations, and safety directives. This individual’s primary job function will be 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.
Job Responsibility:
Perform visual inspection of sterile filled containers (vials) in accordance with all applicable procedures, regulations, and safety directives
Ensure finished drug product vials manufactured by PCI are free of visible defects
Record production quantities and other applicable information with adherence to Good Documentation Practices
Apply a moderate level of math skills to include piece counting, time calculations, and product reconciliation
Follow written procedures and documents results in a neat and accurate manner according to GMP standards and other regulations
Perform daily cleaning of visual inspection and packaging areas in accordance with established procedures
Identify and communicate product quality issues
Maintain attention to detail and quality while completing multiple or repetitive tasks and meeting product timelines
Effectively communicate both verbally and in writing with all levels
Maintain a high level of integrity while balancing all job responsibilities
Perform 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