Visual Inspection Technician I or II

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Position Summary

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. Other job functions include sampling, packaging, and labeling finished product vials in accordance with cGMP’s and established SOP’s.

Essential Duties and 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 included piece counting, time calculations, and product reconciliation

• Follows written procedures and document results in a neat and accurate manner according to GMP standards and other regulations

• Acquires and maintains qualifications to inspect two or more types of product (i.e. clear lyophilized product, clear liquid product, Opaque product, etc.)

• 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

• Supports data entry for product specific metrics by utilizing current systems

• Reviews completed documentation and provides recommendation for process improvements to support existing procedures for continual improvement in conjunction with department supervisor.

• Capable of supporting sampling, packaging, and labeling operations at multiple sites with minimal supervision.

• Performs GMP tasks by executing steps as written through established procedures with minimal supervision.

• Effectively communicates both verbally and in writing with all levels

• Performs setup and operation of production equipment including; inkjet printer, fully automated labeler, and label counter

• Performs all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice

Special Demands

• 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)

• Able to follow written instructions

• Able to communicate with peers in a professional manner

• Able to work as a team

Qualifications

• High school diploma or equivalent required

• 2+ years of previous experience with GMP’s, SOP’s and working in an FDA / EU regulated environment is desired

• Basic computer skills are required.

• Able to understand and follow instructions

• Able to communicate with coworkers and management in a professional manner

• Basic verbal and written skills

• Ability to read, understand, follow and comply with technical and written documents (SOPs) written in English

• Basic verbal and written skills

• Ability to read, understand, follow and comply with technical and written documents (SOPs) written in English

• Attention to detail

• Maintains a high level of integrity while balancing all job responsibilities

• Seeks guidance and clarification for more complex or non-routine tasks

• 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

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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