Quality Specialist I

Catalent Pharma Solutions•Greendale, IN

9d•Onsite

About The Position

The Quality Assurance Specialist I is responsible for auditing the products and processes at various points in the areas of production and packaging to ensure adherence to company quality standards. The Quality Assurance Specialist I will communicate any deviations to management & assist the Quality Assurance team with special projects as required. Greendale is one of Catalent’s gummy technology development and manufacturing facilities in North America. The site manufactures organic and vegan-based nutraceuticals via confection to enhance wellness for all consumers.

Requirements

High School Diploma/GED required.
For business and safety reasons, must be able to communicate effectively verbally and in written English.
Ability to communicate with all line level positions and management.
Knowledge of GMP and Quality systems

Nice To Haves

BS in Food Science or related major is preferred.

Responsibilities

Conduct thorough and detailed quality audits of lines to ensure products meet established quality standards.
Equipment verification including metal detector, x-ray, scales, etc.
Audit paperwork of operators to ensure they are meeting quality standards
Report any deviations to QA Supervisor in complete appropriate details.
Report any housekeeping issues that need attention.
Document all areas of non-compliance and ensure corrective action to eliminate them.
Work with Production and Packaging Managers, Supervisors, and hourly associates on daily issues and problems
Utilize computer to enter and track result data
Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards.
Responsible for ensuring compliance to FDA and cGMP standards for Quality Control, including continuous training.
Responsible for ensuring Dietary Supplement’s Identity, Purity, Strength and Quality.
Participate in all necessary training is required to successfully perform job responsibilities.
Other duties as assigned.