2nd Shift Quality Agent

KDC/ONE POSITION DESCRIPTION

POSITION CODE _____

04/2023

Title: Quality Agent

Reports to: Quality Agent Supervisor

Department: Quality Assurance

Basic Function:
Ensure customer satisfaction though the relentless pursuit of Operational and Quality excellence. To deliver quality products and services, that meet or exceed customer requirements with consideration to cGMP guidelines.

Responsibilities:

1.Reporting to the designated work area at a minimum of 30 minutes prior to shift start.

2.Review, verify, and confirm the following:

2.1)Completion of Line Clearance before starting of line

2.2)Availability and accuracy of Bill of Material (BOM) and Fill & Assembly spec.

2.3)Fill weights are calculated correctly.

2.4)Lot code is accurately assigned by Line Lead

2.5)Pack out is correct.

2.6)Availability of standard, and where applicable, a range board on the line.

2.7)All measuring equipment is calibrated and operated correctly.

2.8)Production personnel follows good hygiene policies and practices.

3.Inspect& approve First Article (FAI) unit prepared by Line Lead before starting of line.

4.Randomly review, verify, and confirm that the production line adheres to specified product requirement, standards, and procedures.

5.Record inspection results by completing reports, summarizing re-works and wastes and inputting data into quality database.

4.Familiar with all quality requirements, procedures, and auditing techniques to the extent for which they are trained.

5.Selectively perform Full Quality Audits on two (2) production lines with potential high-risk to ensure quality requirements are met.

6.Conduct a daily Hand-off/ Pre-shift meeting with the next shift Quality Agents to briefly cross-communicate between the shifts and prepare the incoming team for status updates, changes, or issues relevance to the Production of the upcoming shift.

7.Maintain effective communication among all team members associated to the assigned area(s).

8.Review and confirm the accuracy of Production & Quality Agent documents before submitting to the Product Release Team.

Qualifications:

1.General learning ability to carry out related duties for customer and kdc/one’s quality and quantity standards.

2.Excellent visual inspection to identify defects on the line.

3.Satisfactory clerical ability needed to accurately record necessary data.

4.Excellent eye-hand coordination, finger and manual dexterity needed.

5.Must have ability to read, write and comprehend operating procedures in English.

6. Proficient in mathematics and calculations.(Addition, subtraction, multiplication, division, rounding, and averaging.)

7.Understands assembly operations and basic quality functions.

8.Thorough knowledge of production, cGMP, safety, environmental, quality and HR procedures.

9.Basic computer skills – Entering and printing data.