We're hiring a Senior Associate I – Quality Assurance to support the QA raw materials team at our facility in Madison, Wisconsin!

Catalent is a global, high-growth company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Senior Associate I – Quality Assurance is responsible for the support of onsite quality systems related to raw materials. This team handles the release of raw materials, technical writing, deviations, and supplier change notification assessments. This is a full-time, salaried position and is 100% site based. The schedule is Monday – Friday 1st shift.

Catalent’s Madison, Wisconsin site is a state-of-the-art biomanufacturing facility specializing in integrated formulation and analytical services. Our site features our proprietary Gene Expression Technology (GPEx) cell line engineering platform, and biomanufacturing capabilities utilizing single-use systems. Our 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 is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

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 to the material lifecycle and lot disposition.

• Other duties as assigned.

The Candidate

• Master’s degree in STEM discipline with some related experience preferred, 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.

• Previous cGMP experience preferred.

• Previous quality experience in a pharmaceutical environment preferred.

• Experience working with Standard Operating Procedures (SOPs) preferred.

Why you should join Catalent

• Medical, dental, vision, and wellness benefits are effective on the first day of employment.

• Potential for career growth on an expanding team and organization.

• 152 hours of paid time off annually plus 8 paid holidays.

• Community engagement and green initiatives.

• Engaging D&I Employee Resource Groups.

• Tuition reimbursement program.

• Generous 401K match.

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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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .