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Quality Lab Schedule
1st Shift QC Technician 07:15am-03:15pm
2nd Shift QC Technician 03:15pm-11:15pm
3rd Shift QC Technician 11:15pm-07:15am
Description:
The Quality Technician is capable of conducting, auditing, inspecting, and testing of the Quality System Programs. Each technician must appropriately monitor and respond to all process operating guidelines.
QC Technician Daily Responsibilities
Key point of contact to help identify and resolve issues for any and all food safety, regulatory and quality issues on the shift (holds, sanitation concerns, start-ups, extraneous investigations, etc.)
Product attributes for the previous shift must be reviewed at the beginning of each shift (including net contents). Operations will print all holdable attributes from KPOG for the shift folder which is turned into QA at the end of their shift.
Each technician is to review mixing sheets (207’s) during the shift. When auditing the mixing sheets, errors such as incorrect lot numbers, quantities, temperatures, etc. should be identified.
Review Metal Detector checks completed during the shift and react to any non-conformities, sign off at the end of the shift.
If any metal detector failure/deviation occurs a risk assessment must be completed by the end of your shift on the day of the occurrence.
Create and maintain test packages.
Technician will lead the initial investigation and get the right resources involved in the investigation to complete the 5 why and corrective action sections.
Holds must be documented in the database and must clearly identify the non-conformities. Supporting data should be documented in the hold details. Supporting data includes, but is not limited to, the following: Investigation details, root cause/corrective action, KPOGs data points, specification limits .
Categorize (I, II, or III) holds appropriately
Take pictures of any issues that will support the hold for non-conforming product.
Perform traces in Red Prairie and notify Supervisor/manager if suspect product has shipped.
Request product from the hi-rise, assess pallet timeframes to see which pallets fit the hold timeline for disposition or rework.
Set up rework form and pull samples for retesting. Work with operations to sample/rework Quality Holds.
Reconcile hold folder up to and including holds database, Kwik report and hold form.
Model 26 Documentation is to be reviewed daily. Any deviations should be captured in the Deviation report & Finished Goods hold notice to Quality management and operations (BUMS, Supervisor, etc.).
Extraneous findings should be uploaded to the TeamSite and stored in the file cabinet in the Main Quality office. They are not to be left on the counter.
Lead the extraneous investigations to determine the source. Assist operations in completing the Deviation Reports.
GMP/Food Safety Inspections
Pre-operational inspections must be completed prior to start-up whenever an area has been idle for 8 hours or more. Production lines should not start up unless the required paperwork ins turned into Quality and completed forms are stored in the appropriate binder located in the Quality office
Equipment must be inspected after maintenance work is completed. An orange tag will need to be signed off for these events.
Ad hoc inspections are required for other events that are Quality or Food Safety concerns: environmental issues, bloodborne pathogens, brittle plastic or broken glass
Each QC technician is expected to troubleshoot and resolve issues for equipment occurring on their shift.
Shift Reports must be completed and saved to the team site on a daily basis to keep track of all quality issues that occur on each shift.
_________________________________________________________________________________ Applied Medical is a new generation medical device company with a proven business model…