Visual Inspection Technician II

PCI Pharma Services•Bedford, NH

About The Position

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.

Requirements

Basic computer skills are required.
Able to understand and follow instructions
Able to communicate with coworkers and management in a professional manner
2+ years of previous experience with GMP’s, SOP’s and working in an FDA / EU regulated environment is desired
High school diploma or equivalent required
Attention to detail
Basic verbal and written skills
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)
Seeks guidance and clarification for more complex or non-routine tasks
Able to follow written instructions
Able to communicate with peers in a professional manner
Able to work as a team

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.
Performed GMP tasks by executing steps as written through established procedures with minimal supervision.
Effectively communicates both verbally and in writing with all levels
Perform setup and operation of production equipment including; inkjet printer, fully automated labeler, and label counter
Maintains a high level of integrity while balancing all job responsibilities
Performs all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice