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Sharp Services · 3 months ago

Quality Packaging Associate II - 2nd Shift

Macungie, PA

Full-time

Onsite

New Grad, Entry Level

Sharp Services is seeking a Quality Packaging Associate II to function as a lead associate ensuring compliance with Work Instructions and Company requirements during production activities. The role involves conducting quality inspections, verifying documentation, and ensuring adherence to regulatory standards to maintain customer satisfaction.

Health CareLife Science

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

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