Quality Specialist I

Quality Specialist I

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Welcome to Greendale, Indiana! Greendale is one of two gummy technology development and manufacturing facilities in North America. The site has the capability to manufacture traditional gelatin gummies as well as 100% plant-based pectin gummies for nutritional supplements and nutraceuticals. With extensive development and manufacturing expertise and a wide range of flavors, shapes, sizes, and colors available, we can work with complex ingredients to help create engaging new products consumers will love.

The Quality 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 Specialist I will communicate any deviations to management & assist the Quality Assurance team with special projects as required. The shift for this position will be Monday - Thursday from 6 am - 6 pm.

The Role

• 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. 

The Candidate

• High School Diploma. BS in Food Science or related major is preferred.

• 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.

• The employee must be able to lift and/or move up to 50 pounds. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl, and talk or hear. The employee is required to sit, climb, or balance and taste or smell. The position requires a great deal of walking and standing, approximately 85%.

Why You Should Work At Catalent

• Spearhead exciting and innovative projects

• Fast-paced, dynamic environment

• High visibility to members at all levels of the organization

• 152 hours of PTO + 8 paid holidays

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who i