Jobs and Careers

Quality Assurance Specialist I Quarantine

United Statesfull_timeVerifiedPosted 18 Dec 2024

About the role

Quality Assurance Specialist I Quarantine

Position Summary

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 Assurance Specialist I Quarantine, is responsible for sampling and testing of inbound raw materials and packaging materials to ensure adherence to company quality standards. Communicate any deviations to management. The Quality Assurance Specialist I Quarantine will assist the Quality Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards. This position is a Monday - Friday, 7:30 am - 6 pm shift.

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.

The Role

Responsible for sampling inbound raw materials and packaging materials.
Responsible for completing testing of raw materials and packaging materials.
Report any deviations to QA Supervisor in complete appropriate details.
Document all areas of non-compliance and ensure corrective action to eliminate them.
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

For business and safety reasons, must be able to communicate effectively verbally and in written English.
This position requires BS in Food Science and/or related major or have High School diploma with significant experience in manufacturing and training - HACCP, PCQI, GFSI, cGMP.
Ability to communicate with all line level positions and management.
Attention to detail.
Able to assert himself / herself effectively.
Strong problem-solving skills.
Strong interpersonal skills are essential. Ability to develop cross functional and multinational relationships to support interaction with various internal customers.
Strong analytical skills.
Ability to read and follow documents (Standard Operating Procedures and Test Methods).
Knowledge of GMP and Quality systems.
Knowledge of spoken Spanish is a plus.
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.