Specialist I, Quality Assurance

About Site Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. Position Summary We have an opportunity for a Specialist I, Quality Assurance to join our team. In this role, you will focus on auditing laboratory data to ensure compliance with procedures and regulations in the pharmaceutical industry. You will review critical documentation and support quality processes to maintain high standards. This position plays a key role in ensuring adherence to Good Manufacturing Practices and regulatory guidelines. Shift: M-F 8am-5pm Location: Kansas City, MO 100% Onsite The Role Process documents submitted to Quality, including scanning, printing, and filing Perform laboratory data verification and data audits Lead laboratory facility audits Review and approve Certificates of Analysis, Analytical Result Forms, Stability Reports, and Stability Protocols Follow Good Manufacturing Practices and Good Documentation Practices to ensure compliance with FDA, European, and other applicable guidelines Perform all other duties as assigned The Candidate Minimum Requirements Bachelor’s degree in a science-related field and 4+ years of related work experience, or Master’s degree in a science-related field with no experience required Clear communicator in written and verbal form; seeks answers from standards and regulations and escalates when needed Demonstrates Catalent Leadership Competencies at the Individual level: Integrity, Delivers Results, Business Acumen, Champions Change, Engages, and Develops Responds to problems and identifies solutions; develops methods to address constraints and waits for approval before implementation Collaborates effectively with others; handles conflict constructively and communicates necessary information Builds trust by acting ethically and inclusively; ensures compliance with regulations, policies, and standards; raises questions or concerns when needed Preferred Skills & Background Veterinary or Human Pharmaceutical Quality Assurance or Quality Control experience strongly preferred Why You Should Join Catalent Defined career path with annual performance reviews and feedback Diverse and inclusive culture Opportunities for career growth within an organization dedicated to improving lives Competitive paid time off plus 8 paid holidays Community engagement and green initiatives Medical, dental, and vision benefits effective on day one Tuition reimbursement 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. Catalent is an Equal Opportunity Employer, including disability and veterans. California Job Seekers can find our California Job Applicant Notice HERE. Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis. Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment. #J-18808-Ljbffr Socket.dev