
Job Information
Latitude, Inc. Inspection and Packaging Technician in Baltimore, Maryland
This position is responsible for the inspection and packaging of product. Will perform all aspects of Inspection and Packaging with the ability to assist in day to day operations.
II: Responsibilities
Demonstrate competency on assigned qualification blocks:
Job specific Standard Operating Procedures
New Inspector Qualification and Certification (FTE status is dependent upon gaining certification as a qualified inspector and maintaining that certification)
Execute and document procedural steps in compliance with cGMP standards.
Perform room clearances in accordance with relevant Standard Operating Procedures
Perform 100% visual inspection of product and classify rejected materials utilizing approved categories within required timelines (Qualification)
Successfully complete annual inspector re-qualification requirements
Package product in final packaging components while verifying that lot information, including lot number and expiration date, are accurate
Unload returning product from contract filler and move to cold storage location
Load and unload product from vial labeling machine during labeling process
Package product in final packaging components while verifying that lot information, including lot number and expiration date, are accurate
Maintain state of facility environmental control including: preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing surfaces and equipment per Standard Operating Procedures
Review all documentation generated as each step is completed for accuracy of calculations / data entry and completeness of process signature steps
Stock gowning and consumable supplies in the controlled areas maintaining Just-In-Time inventory (JIT) control of manufacturing materials
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
III: Education, Experience & Skills
HS Diploma or equivalent
0-2 years of relevant experience
Knowledge of cGMP and CFR requirements
IV: Physical/Mental Requirements
Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, reach outward, reach above shoulder, hand dexterity, bend, sense of hearing, lift/carry 25lbs, pull 50lbs Use phone, copier, computer and copier. Work outdoors, noise above conversation level, hot/cold temperatures, and multiple locations. Organize/coordinate, analyze/interpret, problem-solve, make decisions, plan, communicate, prepare transaction documents.