Quality Inspector

Primary Function:

The Quality Inspector is a supporting role for the monitoring of manufacturing and filling/packaging daily activities, coordinating training as needed and support for any challenges on the production floor. The Quality Inspector also supports miscellaneous activities including light clerical and support and pulling of retain samples. Basic decision-making skills are required for how to prioritize work, manage your time, resolve daily challenges with duties listed below.

Key Responsibilities:

• Monitor environmental conditions in the GMP areas
• Daily reading of USP water for production release
• Cleaning Inspection and approval of equipment
• Perform swab sample for equipment cleaning verification
• Approve line clearance of the Packaging / Filling Line Equipment before production runs
• Verify that equipment logbooks have been completely and accurately filled out by Quality and the production associates at the beginning and end of packaging runs
• Ensure the Packaging / Filling lines have the correct and appropriate documentation, packaging components and product before and during packaging runs
• Complete accurately the Packaging Pages
• Complete in-process fill checks throughout the packaging run in accordance with SOP and Packaging Pages.
• Collect Retain and Laboratory evaluation samples as per SOP or Packaging page
• Perform Finished Product counts including Date, Number of pallets, number of cases and performing the appropriate calculations to document accurate counts.
• Back-flush products as pallets complete. This is done in the BEAS system which is an interface to the SAP system
• Print and verify Pallet count sheet and attach Pallet count sheets to the Pallets.
• Back-up to perform
  • Issue of labeling material
  • Label reconciliation sheets
  • Return of unused labels to the label room
• Report Quality non-conformances and Deviations to the Quality Lead and Management.
• Ensure all documentation is reported utilizing cGMP / Good documentation practices and all applicable SOP as well as industry best practices.
• Other duties as assigned by management.

Skills & Knowledge Required:

• Preferred High School Diploma or equivalent.
• Read, Write, Comprehend SOP, Master Batch records, Test procedures and other relevant technical documents in English.
• Perform Calculations
• High level of attention to detail
• Effective written and oral communication in English.