Incident Management Coordinator- Kdc/One Columbus

KDC is a network of best-in-class custom formulators and manufacturers of color cosmetics, skincare, haircare, bath & body, fragrance, deodorant, home, health, industrial, and auto care products. KDC delivers high-touch innovation, operational excellence, and speed to market to well-known and emerging beauty, personal, and specialty companies from coast to coast. KDC has its head office in Longueuil, Québec. In addition, KDC has 10 operating facilities located throughout North America. Altogether, the company employs nearly 4,800 talented and dedicated employees in North America.

Scope:

The Incident Management Coordinator will be responsible for ensuring that any non-conformances (raw material, bulk, finished product, EMP) are documented per site requirement. All non-conformances, corrections/corrective actions and deviations will be tracked to completion and timeliness, monitored during all phases. The position requires skills necessary for auditing, writing investigations, non-conformance reports (NCR), corrections, corrective actions, and document control updates. Ideal candidate must have good understanding of all cGMP and other laboratory related regulatory requirements.

Primary Responsibilities/Accountabilities

• Responsible for managing the investigation of Non-Conforming Materials and Holds ensuring all NCR investigations are complete, are properly closed out, documented as per procedure, and ensuring overall procedural compliance.

• Works with the Quality Control Manager or designee in integrating the Laboratory and Microbiology Out of Specification investigations within the TrackWise system as needed.

• Supports Quality Management during external regulatory and Customer audits.

• Manages audit findings by assigning them to area owners, tracks and facilitates the closure of findings in a timely manner.

• Works with Quality management on the preparation of the Quality Management Review Reports both weekly and monthly metrics as needed.

• Trends complaints, non-conformances, NCR investigations, Corrective Actions and Laboratory and Micro OOS investigations, providing explanation for the significant trends, and calling out when action is required to improve trends. Manages multiple tracking spreadsheets and communications with assigned owners.

• Creates and updates procedures, work instructions, forms, and job aids, when required.

• Performs other duties as necessary.

Education & Experience:

• BA/BS degree in a science related field preferred.

• Minimum of 2 years working in a Quality role in a manufacturing environment.

Knowledge, Skills, and Abilities

• Excellent problem solving , analytical, oral, and written communication skills

• Excellent investigative skills

• Strong organizational skills with the ability to multi-task

• Knowledge of cGMP practices, of Quality laboratory practices and processes, and current FDA guidelines

• Demonstrates attention to detail

• Display high standards of ethical behavior

• Works with minimal supervision

• Skilled in use of computers, particularly word processing software

• Ability to listen, note key points, and work independently

• Flexible to constantly changing priorities.

Minimum Requirements:

• Must be 18 years or older.

• Able to work overtime & weekends, as required.

• Wear hairnet, safety glasses, long pants, steel toe shoes/boots and any other uniform standards.

• Read, comprehend, and follow written and verbal instructions.

• Sit, bend, stoop, climb, and stand for long periods of time in one place.

• Lift items up to 50lbs

KDC-ONE is an equal opportunity employer and does not discriminate on the basis of race, religion, color, national origin, age, sex, gender, disability or any other characteristic protected by law. I understand that employment with KDC-ONE Company is at-will, meaning that I or KDC-ONE Company may terminate my employment at any time, or for any reason consistent with applicable state or federal law. I understand that KDC-One requires the successful completion of a drug and/or alcohol test as a condition of employment.

Other details

• Pay Type Hourly

• Employment Indicator SG&A

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• kdc/one Columbus, 8825 Smith's Mill Rd N, New Albany, Ohio, United States of America