Packaging Associate II 2nd Shift

Sharp ServicesMacungie, PA
120d

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 the requirements outlined in the associated Batch Record or MPR.

Requirements

  • High School Diploma or GED required.
  • Some college education desired.
  • Knowledge of FDA regulations related to cGMP is desired.
  • Prior experience within a manufacturing or alike assembly process preferred.
  • Good documentation and communication skills are required.
  • General knowledge of quality control processes is desired.
  • 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.

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 in the Batch Record.
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