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 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. The Quality Assurance Supervisor will participate and provide oversight of activities supporting Safe Quality Foods (SQF) Certification, Environmental Monitoring Programs, Testing and Release of products to customers. 

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

Hours: 2nd shift - afternoon hours

The Role

• Leads investigations, Deviations and CAPAs related to product quality and assists in Customer Complaint Investigations. Conducts GMP internal audits and supports customer and certification, Regulatory Audits.  Supports annual reviews of the HACCP Plan, SQF Code, SOPs, and other Quality Programs.
• Quality Control data base management and control over product specifications, batch records, labeling and testing of raw materials, WIP and Finished Goods.  Ongoing Food Safety and Quality Program execution – Ensure compliance with SQF/HACCP/QUALITY/SOP programs.
• Manages testing and trending results from Water, EMP & HACCP Programs and conducts OOS investigations as needed. Supports QA Managers in the continuous improvement of food safety and quality programs.
• Conduct verification activities to ensure corrective actions were implemented effectively to prevent reoccurrences. 
• Maintain food safety scorecard metrics and reports trends to Manager/Director of QA. 
• Manage incident reports to track deviations and ensure appropriate follow-up and corrective actions. Supervise, provide guidance and leadership to quality assurance technicians.
• Sets priorities for the team to ensure task completion, coordinates work activities with other supervisors. Training of new and existing employees on food safety and quality programs.
• Provide coverage during production runs on extended shifts and weekends, when needed.
• Participate in all required training.
• Additional QA duties as needed.

The Candidate

• Bachelor’s degree required. Food Science/Food Technology, Biology/Chemistry degree preferred.
• Prior experience in a food processing or dietary supplements manufacturing environment under 21 CFR 111, 117, 11 HACCP, and SQF required.
• Demonstrated leadership managing a team of 3 or more employees required.
• Must work well in team-based environment as well as have the ability to work alone on various projects. Strong organizations and leadership skills; 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.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
• 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

• 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. 

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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.

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:

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