Tech II QC - 2nd Shift

What Quality Control contributes to Cardinal Health

This position is responsible for carrying out the precise inspection of in-process and final pack inspections performed to the sub-assemblies and finished products, following the established procedures & specifications. Produces, inspects and controls label copy for all products manufactured in the Plant.  Controls requisition of label raw materials from stores and maintain up to date material requisitions transactions. This position is also required to perform First Article and validation protocol inspections as required. Completes the appropriate control documents for inspections required.  Incumbent must comply with regulatory requirement, (Quality Systems Regulations, ISO, Quality Manual, EHS, etc) as they apply to the position. May serve as backup for incoming quality inspections.

Qualifications

  • HS Diploma or GED , preferred
  • 2+ years experience in related field, preferred

Accountabilities

  • The incumbent is responsible for verifying, inspecting, dispositioning, and documenting results of all the in-process and final pack product inspections as per applicable procedures including line clearances.
  • Follow the appropriate QCIC's, blue prints or specifications, S.O.P.'s, TM, and determines the disposition of subassemblies and finished goods. Ensures non-conformant product is identified and segregated. Escalates issues to supervisor when non-conformances are issued.
  • Performs validation protocol inspections as per business needs.
  • Inspect all first articles, following the appropriate QCIC's, blue prints or specifications, S.O.P.'s, TM, and determines the disposition of such goods.
  • The incumbent performs line clearances, including label room, and ensures documentation completeness according to procedures.
  • Maintains quality control records, procedures and other documentation accurate, updated and properly organized files.
  • The incumbent is responsible for assuring that all shop orders are accompanied with the corresponding copy of Non Conformance Reports when applicable. Ensures material is segregated when required.
  • Maintains all equipment used for testing and measuring, and keeps the working area in a clean, well-organized condition.
  • Performs review of shop orders for completeness and accuracy. Follows all good documentation practices.
  • Control forms and distributes to manufacturing personnel as required.
  • Coordinates outside laboratory bioburden and pyrogen testing, and prepares required samples and documentation.
  • Reviews and organizes manufacturing Shop Orders by sterilization lot.
  • Performs transactions in PRMS after reconciliation of sterilization lots. Inspects pallet configuration, quantity and information at finished goods staging area as required.
  • Submits DCN’s when updates to controlled documents is required. Produces printed labels per instructions contained in the Label Control Room (official form).
  • Ensures that all labels are correctly printed according to the Device Master Records, including specifications, drawings, procedures and electronic files.
  • Calculates shelf life for products as per applicable procedure. Assures that no labels corresponding to same shop order can have the same sequential number repeated.
  • Assures that lot number, catalog number and expiration date are correct on each roll label.
  • Requests labeling raw material and maintains in process inventory.
  • Documents material requisition transactions. Works on priority orders when released before others to assure compliance with production schedules.
  • Assists in training of new Quality Inspectors.
  • May be assigned to different workstations as required.