Job Description

Senior Associate I - Quality Assurance Operations, Data Review

· Work Schedule: Monday – Friday 8am-5pm

· 100% on-site

Catalent Madison is a pharmaceutical manufacturing site specializing in the development and production of high-quality drug products, with a strong focus on biologics and sterile injectables. The site supports global clients by delivering compliant, reliable, and scalable manufacturing solutions.

The Senior Associate I– Quality Assurance Operation, Data Review at Catalent Madison supports Quality Assurance across a broad range of functions to ensure compliance with FDA regulations and internal quality systems, directly contributing to the production of safe, high-quality biologic drug products. This position spans equipment management, document control, materials quality, training, investigations/CAPA, audits, and on-the-floor manufacturing support. The Senior Associate I– Quality Assurance Operations, Data Review requires close cross-functional collaboration to maintain inspection readiness, drive continuous improvement, and support end-to-end quality oversight from raw materials through final product release.

The Role:

• Responsible for maintaining and enhancing the effectiveness of the Quality System through ensuring compliant preparation and execution of quality control operations.
• Review analytical and microbiology data and documentation including raw data, test methods, protocols, and reports for accuracy, completeness, and compliance in a timely manner.
• Review and report unusual or out-of-specification testing results
• Review supporting documentation including laboratory records and associated documents to ensure traceability to raw data and verify all reagents, standards and equipment used are within the acceptance range.
• Ensure analysts follow all applicable SOPs and CGMP regulations and work with analysts for document corrections and provide guidance accordingly.
• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Other duties as assigned.

The Candidate:

• Master’s degree in STEM discipline with minimum of 0 years related experience.
• OR
• Bachelor's Degree in STEM discipline with minimum of 3 years related experience.
• OR
• Associates Degree in STEM discipline with minimum of 6 years related experience.
• OR
• High School Diploma with a minimum of 7 years related experience.

Why you should join Catalent:

• Potential for career growth on an expanding team
• Abundance of cross-functional exposure to other areas within the organization
• Opportunity to work globally
• 152 hours of paid time off annually + 8 paid holidays
• Day one benefits! Medical, dental, vision and 401K benefits effective on your first day

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 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