Independently perform inspection of product / materials to routinely achieve production and quality standards while following GMPs, SOPs, and standard work documentation on assigned work center; maintain adequate supply / material levels to meet short and long-term safety, quality, and production needs; maintain accurate documentation for duties performed.
Key Responsibilities :
Packaging Operations : In accordance with cGMP documents, standard work documents, and other instructional materials, perform basic measures; weigh, process, and inspect product / materials; maintain adequate material / supply levels; and monitor product variables and attributes throughout preparation to ensure designated parameters and quality attributes are met. Manual Forklift use.
Materials & Supplies : Continuously monitor staging areas and stock materials as needed to maintain production, quality, and safety standards; use transporting equipment safely.
Record Keeping : Accurately maintain documentation related to equipment operations, and troubleshooting for GMP documents, equipment logs, and all other required records used to track equipment activity and status for activities performed.
Training & Instruction : Escalate issues to management for resolution and maintain training compliance in the Learning Management System
EHS Responsibilities – All Associates
Know, understand, and comply with all Environment, Health and Safety (EHS) guidelines
Report unsafe conditions
Report all injuries, illnesses, and hazardous materials releases
Wear personal protective equipment
Attend EHS training programs
Follow all safe work procedures
Quality Responsibilities – All Associates
Adhere to all Quality Compliance standards (Data Integrity, QA, and QC, etc.)
Adhere to QMS policy and regulatory requirements
Knowledge / Education / Experience Required :
Minimum Education Level - High School degree or equivalent
Other Job-Related Skills / Background :
Required -
Ability to follow both written and verbal instruction
Strong attention to detail and ability to create and follow detailed documentation
Current associate must meet requirements from Operator Career Path Job Ladder
Preferred -
Prior experience with cGMP documentation
Experience with a lean organization or other prior exposure to lean concepts, tools, and technique
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