Quality Specialist I

Posted 15 Hours Ago
Be an Early Applicant
Greendale, IN
Entry level
Biotech • Pharmaceutical
The Role
As a Quality Specialist I, you will perform quality audits on production and packaging processes, ensuring compliance with quality standards. You'll document non-compliance, report issues, and support the Quality Assurance team. The role involves using a computer for data tracking and requires knowledge of GMP and food safety regulations.
Summary Generated by Built In

Quality 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 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 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 [email protected]. 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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

The Company
HQ: Somerset, NJ
13,715 Employees
On-site Workplace
Year Founded: 2007

What We Do

Catalent Inc. (NYSE: CTLT), an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.

Catalent supports our partners in introducing 200 new products and manufacturing over 70 billion doses each year. Since becoming a publicly traded company in 2014, we have grown to become a community of approximately 19,000+ workers who support over 7,000 products for over 1,000 customers around the world. We share a common goal: to put patients first and help people around the world live better and healthier lives.

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. We have the deepest expertise, the broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging results.

more products. better treatments. reliably supplied.™

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech, and healthcare companies, will help bring life-enhancing products to life.

Grow with us. Be challenged. Make a personal impact.

Visit https://careers.catalent.com/us/en to explore career opportunities

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