Quality Packaging Associate II - 3rd Shift

Sharp Packaging Services•Allentown, PA

1d•Onsite

About The Position

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: The following is a list of minimum responsibilities related to the Packaging Associate II position. Other duties may also be assigned. Adherence to and enforcement of GMP compliance, performing Quality inspections (equipment challenges and verification, components, bulk product, work-in-process and finished goods) related to contract packaging, reviewing documentation and verifying component attributes. The impact of the quality inspection process directly impacts company compliance with regulatory requirements and customer satisfaction. Read and understand process steps within the packaging record to ensure compliance during the packaging process. Assist where needed with the overall efficiency of the production within the assigned room or rooms. Inspect units for quality as they are packaged. Responsible for performing quality inspections as required per the packaging record and per AQL requirements. Inspections may include visual, functional, destructive and count checks. Verify the accuracy, completeness and supported documentation of the packaging requirements outlined below and ensure all are supported by the appropriate documentation within the Batch Record. Pre-start Equipment Room Check and Area clearance pages Pre-Post Production Pages Pre-Packaging Steps Equipment Verification page(s) Equipment / Component Startup Verification page(s) Challenges In-Process Inspections Quality Samples Reconciliation Check weigher Sheets Product/Component Transactions Waste logs TOR Logs as Applicable

Requirements

High School Diploma or GED required
Good documentation and communication skills are required
Highly attune and focus 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

Nice To Haves

Some college education desired
Knowledge of FDA regulations related to cGMP is desired
Prior experience within a manufacturing or alike assembly process preferred
General knowledge of quality control processes is desired

Responsibilities

Adherence to and enforcement of GMP compliance
Performing Quality inspections (equipment challenges and verification, components, bulk product, work-in-process and finished goods) related to contract packaging
Reviewing documentation and verifying component attributes
Read and understand process steps within the packaging record to ensure compliance during the packaging process
Assist where needed with the overall efficiency of the production within the assigned room or rooms
Inspect units for quality as they are packaged
Responsible for performing quality inspections as required per the packaging record and per AQL requirements
Verify the accuracy, completeness and supported documentation of the packaging requirements outlined below and ensure all are supported by the appropriate documentation within the Batch Record
Pre-start Equipment Room Check and Area clearance pages
Pre-Post Production Pages
Pre-Packaging Steps
Equipment Verification page(s)
Equipment / Component Startup Verification page(s)
Challenges
In-Process Inspections
Quality Samples
Reconciliation
Check weigher Sheets
Product/Component Transactions
Waste logs
TOR Logs as Applicable