Senior Associate I - Quality Assurance Operations, On the Floor

About 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 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 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. Perform or support any other tasks necessary to maintain the product quality and site CGMP compliance. Files and maintains controlled documents. 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 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