Quality Assurance Specialist I
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 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.
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide.
Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
Hours: Monday -Thursday 6am to 4:30 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 work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate to loud. The position requires working in a humid and warm environment.
- 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 Join Catalent
- Competitive medical benefits and 401K
- 152 hours of PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes