Senior Specialist I - Quality Assurance Operations, On the Floor

Senior Specialist I – Quality AssurancePosition Summary:Work Schedule: M-F 8am-5pm100% on-siteWorking 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 Specialist I – Quality Assurance.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.The Role:Ensures compliant manufacturing execution. Participates in deviations, CAPA, and change control investigations.Oversees Cell Bank inventory.Reviews and approves production and technical documents.Supports QA-on-the-floor and CGMP documentation review.Leads continuous improvement initiatives.Notifies management of quality or regulatory risks.Performs additional duties to maintain compliance.Other duties as assigned All other duties as assigned.The Candidate:PhD in STEM discipline with 7+ years of related experience, ORMaster’s in STEM discipline with 10+ years of related experience, ORBachelor’s in STEM discipline with 15+ years of related experience, ORAssociate’s in STEM discipline with 17+ years of related experienceStrong knowledge of: cGMP, FDA, EMA, ICH guidelinesExperience with: TrackWise, ComplianceWireCapabilities: Investigations, deviations, CAPA, Risk assessments (FMEA, FTA, etc.), Data analysis and trend interpretationWhy 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 innovativePotential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidaysGenerous 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 View email address on click.appcast.io. 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 View email address on click.appcast.io for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE.SummaryLocation: Madison, WIType: Full time