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Allentown, Pennsylvania, United States
Onsite
We’re part of a team where ideas spark change. At Sharp we embrace innovation; we are open to new technology and new thinking. Each day we volunteer ideas, ask questions, and encourage others to do the same - always trying to make things better. Our culture celebrates learning and we expand our skills and gain new knowledge with every project and initiative.
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
What We Offer:
We believe it is a privilege to work in the life science industry. We believe that our work matters. We are united through our values and our common purpose which is to help our clients succeed and ensure their patients who have medical needs can live a better life.
Apply now and become part of a workplace where commitment drives success, and every voice matters.
Let’s build Sharp. Let’s grow bold. Let’s do more—together.
