Quality Specialist I

Catalent•Greendale, IN

2d•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. This role conducts thorough and detailed quality audits of lines to ensure products meet established quality standards. It also involves equipment verification including metal detector, x-ray, scales, etc., and auditing operator paperwork to ensure they are meeting quality standards. The specialist will report any deviations to the QA Supervisor with complete and appropriate details, and report any housekeeping issues that need attention. Documenting all areas of non-compliance and ensuring corrective action to eliminate them is also a key responsibility. This role works with Production and Packaging Managers, Supervisors, and hourly associates on daily issues and problems, utilizes a computer to enter and track result data, and complies with SQF, Food Safety Plan (HACCP), and Food Quality Plan (FQP) standards. The position is responsible for ensuring compliance to FDA and cGMP standards for Quality Control, including continuous training, and ensuring the Identity, Purity, Strength, and Quality of Dietary Supplements. Participation in all necessary training is required to successfully perform job responsibilities. Other duties as assigned.

Requirements

High School Diploma/GED required.
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.