Quality Specialist I

Catalent Pharma Solutions • Greendale, IN

3d • Onsite

About The Position

Quality Specialist I Position Summary Work Schedule: Monday to Friday, 11PM-7:30AM 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.

Requirements

• High School Diploma or GED required.
• 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%.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees