Senior Associate I - Quality Assurance Systems, SQM

Senior Associate I - Quality Assurance Systems, SQM

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 Associate I - Quality Assurance Systems, SQM.
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 actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients.

The Role:

• Accountable for the incoming material inspection and disposition process.
• Collaborates with Quality Control, Materials Management and Manufacturing to ensure that suitable
  materials are available for use.
• Manage processing defective materials, including disposition and identification of corrective action as
  necessary. Provides support for the introduction of new materials.
• Creates, revises, and maintains material specifications.
• Support management and assessment of supplier notifications and material change requirements.
• Maintains the records pertaining the material lifecycle and lot disposition
• Assists in the customer and supplier auditing process providing administrative support including
  information gathering and organization.
• 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:

• 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 a