Senior Specialist I - Quality Assurance Operations, On the Floor

Senior Specialist I – Quality Assurance

Position Summary:

• Work Schedule: M-F 8am-5pm
• 100% on-site

Working  for  Catalent  Biologics  is  an  opportunity  to  join  an  entrepreneurial  team.   Catalent  Biologics  is  making significant investments in people and capabilities.  This is a unique opening to join a small, fast-growing business, backed by a global public company.  People joining our team will have the opportunity for career development as our  business  continues  to  grow  and  expand.   Catalent-Madison  employees  are  helping  to  improve  future  patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s. 

Catalent Pharma Solutions in Madison, WI is hiring a Senior Specialist I – Quality Assurance.
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.

The Role:

• Ensures compliant manufacturing execution.
•  Participates in deviations, CAPA, and change control investigations.
• Oversees Cell Bank inventory.
• Reviews and approves production and technical documents.
• Supports QA-on-the-floor and CGMP documentation review.
• Leads continuous improvement initiatives.
• Notifies management of quality or regulatory risks.
• Performs additional duties to maintain compliance.
• Other duties as assigned All other duties as assigned.
   

The Candidate:

• PhD in STEM discipline with 7+ years of related experience, OR
• Master’s in STEM discipline with 10+ years of related experience, OR
• Bachelor’s in STEM discipline with 15+ years of related experience, OR
• Associate’s in STEM discipline with 17+ years of related experience
• Strong knowledge of: cGMP, FDA, EMA, ICH guidelines
• Experience with: TrackWise®, ComplianceWire®
• Capabilities: Investigations, deviations, CAPA, Risk assessments (FMEA, FTA, etc.), Data analysis and trend interpretation

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Positive working environment focusing on continually improving processes to remain innovative
• 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 effective day one of employment 
• 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 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