Principal Specialist - Quality Assurance

Principal Specialist I - Quality Assurance (QA) Position Summary

Work Schedule:

Monday – Friday, core hours 8am-5pm
100% on-site (Madison, WI)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics.

The Principal Specialist I in QA will support the QA Systems group which has ownership over the quality systems, including deviations and Corrective and Preventive Actions (CAPAs), change controls, document control, Standard Operating Procedure (SOP) revisions, and training. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients.

• Responsible for managing individual quality systems (QMS), such as:
  Investigation, CAPA Management and Change Control Systems
• Responsible for managing complex and high-level deviations and change controls, supporting Out-of-Specification (OOS) investigations, and collaboration with internal Catalent stakeholders to support the effective execution of the quality 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, OOS, CAPA, and Change Control processes
• Develops and provides training to support consistent and effective execution of the Change Control, Investigation, and CAPA Management Systems
• Provides notification to external clients on Change Controls, Deviations, or Investigations, as required. Files and maintains controlled documents
• Drives alignment and improvement initiatives, leading cross functional teams, to address process improvement, system improvement, and new regulations/expectations. Provides technical assistance and training for personnel
• Other duties as assigned

• STEM-related degree is required:
  Associate’s Degree minimum is required with 25 years of related experience. Highly preferred to have a Bachelor’s with 22 years OR Master’s with 17 years OR a PhD with 14 years of relevant experience (defined below)
• Must have deep technical understanding of Microsoft Office programs and a QMS such as Track Wise or Compliance Wire
• Must have strong understanding of regulatory guidelines (i.e. cGMP, ICH, FDA, EMA, etc.) and the ability to complete investigations, deviations, and change controls independently
• Advanced understanding of pharmaceutical laboratory and/or production operations. Biologics knowledge in a CDMO environment highly preferred.
• Hands on experience with Risk Assessment (especially Hazard Analysis, Fault Tree Analysis, FMEA, etc.)
• 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
• Physical requirements:
  
  Individual must be able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities.

• 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 PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

Catalent offers rewarding opportunities to further…