Packaging Associate II 2nd or 3rd Shift

Sharp Services•Macungie, PA
•Onsite

About The Position

Our work truly matters and our resourcefulness can make all the difference in getting life-saving drugs to the people who need them, when they need them. We’re more efficient and effective when we’re not overly bound to a set way of working. Bring your resourcefulness and agility to continue your career at Sharp. 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 Batch Record or MPR.

Requirements

  • 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 Batch Record or MPR.
  • 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.
  • 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.

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

Benefits

  • Competitive salary and benefits.
  • Opportunities for continuous learning and advancement.
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