Senior Associate I - Quality Assurance

Company: Disability Solutions
Location: Madison
Posted on: February 2, 2025

Job Description:

Senior Associate I - Quality AssurancePosition SummaryCatalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. --The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI.--Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.The Senior Assocaite I - Quality Assurance provides direct quality support for routine manufacturing operations. The Senior Associate I - Quality Assurance reviews documentation for production of solutions and columns used in the manufacture of bulk drug substance.Shift: Monday-Friday 2 PM-10 PMCatalent 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 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.
• 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, environmental monitoring data, and logbooks, for production of solutions and columns used in the manufacture of bulk drug substance.
• Performs release of produced solutions and columns.
• Assists with inspection of final product containers and supports shipment of finished products.
• Responsible for review of facility and equipment records in support of GMP operations.
• Accountable for control and management of Cell Bank inventory.
• Notifies Management of potential quality or regulatory issues that may affect product quality or regulatory compliance and perform or support any other tasks necessary to maintain the product quality and site CGMP compliance Files and maintains controlled documents.
• Other duties as assignedThe Candidate
  • Masters degree in STEM discipline with minimum of --0 years related experience, OR Bachelors 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 --
  • Ability to use Excel, Word, and other office systems. Ability to learn and use quality management software such as TrackWise or ComplianceWire. Ability to understand and independently apply CGMPs to everyday work.
  • Intermediate understanding of pharmaceutical laboratory and/or production operations.
  • Ability to see and hear and read and write clear English. Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping.Why You Should Join Catalent
    • Several Employee Resource Groups focusing on D&I--
    • Tuition Reimbursement---- Let us help you finish your degree or earn a new one!--
    • Generous 401K match--
    • 152 hours accrued PTO + 8 paid holidays--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 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 . 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 .

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