Specialist I - Quality Assurance, Systems
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 Quality Assurance Department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients
and their patients.
The Quality Assurance Systems group has ownership over the quality systems, including deviations and CAPAs, change controls, document control, raw material testing and disposition, and training.
This is a full-time on-site salaried position, Monday - Friday, 8:00am - 5:00pm
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.
The Role:
- Accountable for the Investigation and CAPA Management Systems
- Responsible for managing complex and high-level deviations, supporting OOS investigations, and collaboration with internal Catalent stakeholders to support the effective execution of the Investigation and CAPA systems
- Maintains and enhances effectiveness of the Quality System, including developing and reporting metrics, identification, and implementation of improvement opportunities for established Quality Systems, processes, procedures, and training to support Deviation, Out-of-Specification and CAPA processes
- Drives alignment and improvement initiatives, leading cross function teams, to address process
improvement, system improvement, and new regulations/expectations - Provides technical assistance and training for personnel
- Files and maintains controlled documents
- Other duties as assigned
The Candidate:
- Must have Doctorate Degree in STEM discipline with minimum of 0 years related experience OR
- Master's Degree in STEM discipline with minimum of 4 years related experience OR
- Bachelor's Degree in STEM discipline with minimum of 6 years related experience OR
- Associate’s Degree in STEM discipline with minimum of 10 years related experience.
- Prior work experience with quality management software such as TrackWise preferred
Why you should join Catalent:
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 hours of paid time off annually + 8 paid holidays
- Competitive salary with yearly bonus potential
- Community engagement and green initiatives
- Generous 401K match and Paid Time Off accrual
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement
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.
Top Skills
What We Do
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. For more information, visit www.catalent.com.
