Assistant Quality Supervisor

Assistant Quality Supervisor

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.

Under the direction of the QA Manager, the Assistant Quality Supervisor will lead Dietary Supplement and food manufacturing QA activities in line with Food Safety and 21 CFR 111, 21 CFR 117 and 21 CFR 11 Quality programs. This includes participation and oversight of activities supporting Safe Quality Foods (SQF) Certification, Environmental Monitoring Programs, Testing and Release of products to customers. The Assistant Quality Supervisor will assist in investigations, Deviations and CAPAs related to product quality and Customer Complaint Investigations. The regular working hours for this position are Monday - Thursday from 6 pm - 6 am.

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

• Conducts routine GMP internal audits and daily checks, issue batch records to the manufacturing and packaging floor. 

• Review executed batch records and addresses issues found with other departments during their shift. 

• As required, will support customer, and certification, and Regulatory Audits.

• Ensures compliance with SQF requirements, monitoring of critical control points per the HACCP Plan and current Catalent SOPs. 

• Collection and submission of product, water, surface & air samples, and review of COAs from third party Labs against current specifications. 

• Conducts effectiveness checks to confirm corrective actions were implemented to prevent reoccurrences.

• Creates and assists operations in the initiation of incident reports, deviations, investigations and ensures appropriate follow-up and corrective actions.

• Provide training and guidance to quality assurance specialists on a day-to-day basis and sets priorities for the team to ensure task completion, coordinates work activities with other department leaders. 

• Provide coverage during production runs on extended shifts and weekends. 

• All other duties as assigned.

The Candidate

• Bachelor’s degree in food science/food technology, Biology/Chemistry preferred.   

• Prior experience in a food processing or dietary supplements manufacturing environment under 21 CFR 111, 117, 11 HACCP, and SQF required.

• Demonstrated leadership experience. Direct people management experience required. 

• Must work well in team-based environment as well as can work alone on various projects.

• Strong leadership skills, proven experience as team lead/people management experience. 

• Ability to analyze processes for Biological, Chemical and Physical hazards at each step of a production process. 

• Ability to work with cross functional departments within the organization. 

• Good problem solving, verbal and communication skills, excellent analytical and decision-making abilities. Ability to prioritize and follow-through to achieve results and meet deadlines. 

• 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 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.

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