Quality Packaging Associate II - 3rd Shift

Sharp Packaging Services • Allentown, PA

7d • 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.

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.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 1,001-5,000 employees