Assistant Technician, Inspection & Packaging-2nd Shift

Bora Pharmaceuticals Injectables•Baltimore, MD

10d•$40,000 - $60,000

About The Position

The Assistant Technician, Inspection & Packaging is responsible for inspecting and packaging products and supporting day-to-day operations. The role supports second-shift operations, working Monday through Friday from 2:00 p.m. to 10:30 p.m., with a 10% shift differential. The technician performs assigned qualification blocks, follows and documents procedures in compliance with cGMP standards, conducts room clearances, and safely moves and documents product and materials, including in room-temperature and cold-storage locations. The role also maintains facility environmental controls, performs scheduled cleaning of manufacturing surfaces and equipment, checks process documentation for accuracy and completeness, and participates in a weekly rotation monitoring temperature chart recorders. Packaging duties include manually packaging products, verifying lot information, and operating labeling, cartoning, serialization, and aggregation equipment independently or with minimal supervision after skills assessment. The technician also troubleshoots basic line issues and identifies and champions process improvements. Training and education may be conducted using virtual reality or artificial intelligence.

Requirements

High school diploma or equivalent.
Minimum of 1 year of relevant experience.
Ability to work independently with limited supervision.
Knowledge and ability to make process-related decisions.
Knowledge of cGMP and CFR requirements.

Responsibilities

Demonstrate competency on assigned qualification blocks, including job-specific Standard Operating Procedures and annual inspector re-qualification.
Execute and document procedural steps in compliance with cGMP standards.
Perform room clearances in accordance with relevant Standard Operating Procedures.
Follow procedures and safe practices for moving products and materials, and accurately complete applicable documentation, including for room-temperature and cold-storage locations.
Maintain facility environmental controls, including preparing defined concentrations of cleaning solutions and performing scheduled cleaning of manufacturing surfaces and equipment.
Review documentation generated at each process step for accurate calculations and data entry and complete process signature steps.
Monitor chart recorders for temperature-controlled areas as part of a weekly rotation.
Manually package products in final packaging components and verify lot information, including lot number and expiration date.
Operate labeling, cartoning, serialization, and aggregation equipment independently or with minimal supervision after skills assessment.
Load and unload cartoning, serialization, and aggregation equipment as required.
Identify and champion process improvement initiatives.
Perform basic troubleshooting of line issues.