Packaging Associate II 2nd Shift

SUMMARY

Function as lead associate responsible for verifying that all systems and processes are compliant with Work Instructions and Company requirements in order to begin and/or finish production activities within a specified room or rooms. Throughout production conduct attribute inspections, asset verifications and component delivery and removals according to the requirements outlined in the associated Batch Record or MPR.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Adherence to and enforcement of GMP compliance, performing Quality inspections (equipment challenges and verification, components, bulk product, work-in-process and finished goods)
• Reviewing documentation and verifying component attributes
• Ensuring compliance during the packaging process by reading and understanding process steps within the packaging record
• Absorbing and assisting with the overall efficiency of the production within the assigned room or rooms
• Inspecting units for quality as they are packaged
• Performing quality inspections as required per the packaging record and per AQL requirements
• Verifying the accuracy, completeness and supported documentation of the packaging requirements outlined below and ensuring all are supported by the appropriate documentation within the Batch Record
• Conducting pre-start Equipment Room Check and Area clearance pages, Pre-Post Production Pages, Pre-Packaging Steps, Equipment Verification pages, Equipment / Component Startup Verification pages, Challenges, In-Process Inspections, Quality Samples, Reconciliation, Check weigher Sheets, Product/Component Transactions, Waste logs, TOR Logs as applicable

QUALIFICATIONS

• High School Diploma or GED required
• Some college education desired
• Knowledge of FDA regulations related to cGMP is desired
• Prior experience within a manufacturing or alike assembly process preferred
• Good documentation and communication skills are required
• General knowledge of quality control processes is desired
• Highly attuned and focused on attention to detail is required
• Good organizational and planning skills are required
• Successful completion of the Quality@Source (Q@S) training assessment for the Quality In-Process Inspections as assigned to this position

PHYSICAL DEMANDS

• Regularly required to use hands to handle or write and to speak and hear
• Frequently required to stand, walk, and reach with hands and arms
• Occasionally required to lift and/or move up to 30 pounds
• Subject to mandatory overtime if scheduling requires
• Requires close vision, distance vision, and ability to adjust focus

WORK ENVIRONMENT

• Normally required to stand for long periods of time within a production room
• Exposed to moving mechanical parts
• Noisy environment with moderate noise levels
• Clean and not normally subject to hazardous environment or conditions