Alphanumeric is hiring a PACKAGING OPERATOR - Level 1 to work in Lincoln, NE with one of the largest pharmaceutical companies in the world.
Independently perform clean, change over, set up, operation of packaging equipment, and 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; support process and equipment improvements; maintain accurate documentation for duties performed; and assist others in their training, understanding and performance of tasks and duties
* PACKAGING OPERATIONS: In accordance with cGMP documents, standard work documents, and other instructional materials, independently operate packaging equipment at various workstations; 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.
* EQUIPMENT CLEAN, CHANGE OVER and SET UP: Independently perform cleans, changeovers, and set ups of multiple pieces of equipment in support of effective operations in accordance with required timeframes and cGMP documents, standard work documents, and other instructional materials.
* EQUIPMENT TROUBLESHOOTING and REPAIRS: Perform basic equipment adjustments during production at the direction of senior operators which do not require intermediate or advanced mechanical or technical skills as to include, but not limited to, clearing jams, making adjustments, stopping and restarting machines, loading materials, etc.; escalate issues appropriately.
* AUTONOMOUS MAINTENANCE / PROCEDURE DEVELOPMENT: Perform and/or assist as directed with autonomous maintenance activities as required by cGMP documents, standard work documents, and other instructional materials; participate in procedure development, revision, and documentation.
* 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, cleanings, calibrations, adjustments, and troubleshooting for GMP documents, equipment logs, cleaning logs, Tier 1 boards, and all other required records used to track equipment activity and status for activities performed. Perform all assigned ERP transactions for the work center.
* COACHING, 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
This position requires that all workers be fully vaccinated against COVID-19 and proof of vaccination will be required. Considerations will be made for those seeking Medical Exemption under ADA or Religious exemption under Title VII