Coordinator - QA Product Release NL - 1st Shift

KDC One•Manitowoc, WI

4d•Onsite

About The Position

The purpose of this position is to ensure the totality of features and/or processes (which deem a product as being “fit for use”) are met, prior to release of the product for shipping. The scope of this position pertains to the release of finished goods.

Requirements

Experience with ISO 9001, BRCGS Consumer Product, Good Documentation Practices (GDPs) and current Good Manufacturing Practices (cGMP) preferred.
Stand 20% of the time.
Walk 20% of the time.
Sit 60% of the time.
Use hands to handle or touch 100% of the time.
Reach above shoulders less than 10% of the time.
Climb or balance less than 10% of the time.
Talk or hear 50% of the time.
Smell up to 10% of the time.
Lift up to 50 pounds up to 5% of the time.
Close Vision (clear vision at 20 inches or less).
Color Vision (ability to identify and distinguish colors).
Ability to Adjust Focus (ability to adjust the eye to bring an object into sharp focus).
Use the Computer up to 85% of the time.
Use the Copier less than 5% of the time.
Use the Telephone up to 10% of the time.
Work near moving mechanical parts less than 15% of the time.
Work in high, precarious places less than 5% of the time.
Exposed to fumes or airborne particles up to 50% of the time.
Risk of electrical shock less than 5% of the time.
Work/job related travel less than 5% of the time.
Moderate Noise.

Responsibilities

Timely review completed production paperwork to ensure the conformity of the produced lots of products (i.e., in-process and QC checks of fill weights, torques, lot codes, components; 1st Case & 1st Pallet Checks; line clearance; C&S steps, etc.).
Ensure each completed lot of finished goods had the required retains collected.
Ensure GDPs are followed; have incomplete/incorrect entries properly corrected.
Based on the above, decide if the product can be Released or it must be Rejected. If rejected, ensure/follow up the investigation (which may involve a finished good audit, component recount, rework, Deviation/Waiver, or CPA), so that all aspects are complete prior to potential release of the product.
Create rework plan & packet.
Once rework packet is completed, packet is passed to Planner.
Review completed reworks to ensure all aspects of the rework plan were followed; update the NC report in the system, prior to potential release of the product.
Once released, scan completed production lot paperwork and save in the system database.
Collect, document & ship micro samples.
Update any specific customer spreadsheet tracker.
Release products based on confirmation from Microbiologist or Lab Supervisor based on micro results.
Ensure obsolete items (raws, components, formulas, finished goods, etc.) are efficiently made obsolete, by maintaining, updating, and coordinating the reporting with various departments.
Conduct assigned sections of Annual Product Reviews (APRs).
Perform other duties as assigned by management.