Catalent Inc
Senior Quality Systems Specialist
Position Summary
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.
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.
Catalent Consumer Health is seeking a
Senior Quality Management Systems Specialist
to join our dynamic Quality Assurance team at our Greendale, Indiana site. This role is critical to the integrity and continuous improvement of our site's Quality Systems and will be responsible for managing and supporting key compliance and quality system activities such as Change Controls, Deviations, Complaints, CAPAs, Metrics, Statistical Analysis, and Data Integrity for computerized systems. The
Senior Quality Management Systems Specialist
will bring a strong understanding of GMP principles, experience in pharmaceutical or dietary supplement manufacturing, and a proactive mindset to drive system improvements. This position is 100% based on-site in Greendale, IN.
The Role
Own and manage site-level quality systems such as: Change Control and Deviation processes in accordance with internal procedures and regulatory expectations.
Ensure timely and thorough investigation, documentation, and closure of quality events.
Support cross-functional teams in root cause analysis and CAPA development.
Develop and maintain Quality System metrics and dashboards to monitor performance and identify trends.
Perform statistical analysis using tools such as Minitab or equivalent to support investigations and continuous improvement.
Present data-driven insights to site leadership and global stakeholders
Support Data Integrity initiatives for electronic systems including TrackWise, EDMS, and other validated platforms.
Participate in system upgrades, validation activities, and periodic reviews to ensure ongoing compliance.
Collaborate with Document Control and QA teams to ensure controlled documents are accurate, current, and compliant.
Support internal, client, and regulatory audits by preparing documentation and responding to inquiries.
Other duties assigned
The Candidate
Bachelor's degree in scientific, engineering, or technical discipline required
5+ years of experience in a GMP-regulated environment required. Pharmaceutical or dietary supplement industry experience preferred.
Strong working knowledge of Change Control, Deviation, and CAPA processes.
Experience with TrackWise, EDMS, and Microsoft Office Suite.
Familiarity with statistical tools such as Minitab or JMP.
Experience supporting Data Integrity and computerized system validation.
Prior involvement in audit preparation and response.
Lean Six Sigma or similar continuous improvement training.
Project Management experience is a plus.
Technical Writing experience is preferred.
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 (https://careers.catalent.com/us/en) 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:
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 spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .
Position Summary
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.
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.
Catalent Consumer Health is seeking a
Senior Quality Management Systems Specialist
to join our dynamic Quality Assurance team at our Greendale, Indiana site. This role is critical to the integrity and continuous improvement of our site's Quality Systems and will be responsible for managing and supporting key compliance and quality system activities such as Change Controls, Deviations, Complaints, CAPAs, Metrics, Statistical Analysis, and Data Integrity for computerized systems. The
Senior Quality Management Systems Specialist
will bring a strong understanding of GMP principles, experience in pharmaceutical or dietary supplement manufacturing, and a proactive mindset to drive system improvements. This position is 100% based on-site in Greendale, IN.
The Role
Own and manage site-level quality systems such as: Change Control and Deviation processes in accordance with internal procedures and regulatory expectations.
Ensure timely and thorough investigation, documentation, and closure of quality events.
Support cross-functional teams in root cause analysis and CAPA development.
Develop and maintain Quality System metrics and dashboards to monitor performance and identify trends.
Perform statistical analysis using tools such as Minitab or equivalent to support investigations and continuous improvement.
Present data-driven insights to site leadership and global stakeholders
Support Data Integrity initiatives for electronic systems including TrackWise, EDMS, and other validated platforms.
Participate in system upgrades, validation activities, and periodic reviews to ensure ongoing compliance.
Collaborate with Document Control and QA teams to ensure controlled documents are accurate, current, and compliant.
Support internal, client, and regulatory audits by preparing documentation and responding to inquiries.
Other duties assigned
The Candidate
Bachelor's degree in scientific, engineering, or technical discipline required
5+ years of experience in a GMP-regulated environment required. Pharmaceutical or dietary supplement industry experience preferred.
Strong working knowledge of Change Control, Deviation, and CAPA processes.
Experience with TrackWise, EDMS, and Microsoft Office Suite.
Familiarity with statistical tools such as Minitab or JMP.
Experience supporting Data Integrity and computerized system validation.
Prior involvement in audit preparation and response.
Lean Six Sigma or similar continuous improvement training.
Project Management experience is a plus.
Technical Writing experience is preferred.
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 (https://careers.catalent.com/us/en) 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:
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 spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .