Quality Assurance Specialist I Quarantine

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.

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 [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.