Principal Specialist I 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 263000 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.

The Role:

• 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

The Candidate:

• STEM-related degree is required: Associates Degree minimum is required with 25 years of related experience. Highly preferred to have a Bachelors with 22 years OR Masters 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 TrackWise or ComplianceWire
• 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.

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 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 your career! Join the global drug development and delivery leader and help us bring over 7000 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 . 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.