Quality Specialist I

Position Summary 

• Work Schedule: Monday to Friday, 3PM - 11:30PM

• 100% on-site in Greendale, IN

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. 

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.

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/GED required. 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 

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 is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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