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Associate II - Quality Assurance

Position Summary:

+ **Work Schedule:** Sunday - Wednesday, 6:00am to 4:00pm CST

+ 100% on-site

Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 102,723 sq. ft. site offers integrated formulation and analytical services to address complex development challenges in biologics.

The Quality Assurance Operations group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping.

The Role:

+ Accountable for execution of the QA on the Floor program

+ Performs routine walkthroughs of the Manufacturing Area partnering with manufacturing on Quality best practice implementation and troubleshooting when problems arise

+ Provides direct quality support for routine manufacturing operations

+ Responsible for issuance of controlled documents for production, including Batch Production Records, Product Labels and forms

+ Responsible for review of documentation, including batch records, test data and logbooks, for production of solutions and columns used in the manufacture of bulk drug substance

+ Assists with inspection of final product container

+ Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance

+ Other duties as assigned

The Candidate:

+ Must have Bachelor's Degree in STEM discipline with minimum of 1 years related experience **OR** Associate’s Degree in STEM discipline with minimum of 4 years related experience **OR** High School Diploma with a minimum of 6 years related experience

+ Must have a basic understanding of pharmaceutical laboratory and/or production operations

+ Must be detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines

+ Proficiency in MS Office is required

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 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 (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 [email protected] . 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 [email protected] 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) .