Specialist I, Quality Assurance

About SiteCatalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.Position SummaryWe 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-5pmLocation: Kansas City, MO100% OnsiteThe RoleProcess documents submitted to Quality, including scanning, printing, and filingPerform laboratory data verification and data auditsLead laboratory facility auditsReview and approve Certificates of Analysis, Analytical Result Forms, Stability Reports, and Stability ProtocolsFollow Good Manufacturing Practices and Good Documentation Practices to ensure compliance with FDA, European, and other applicable guidelinesPerform all other duties as assignedThe CandidateMinimum RequirementsBachelor’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 requiredClear communicator in written and verbal form; seeks answers from standards and regulations and escalates when neededDemonstrates Catalent Leadership Competencies at the Individual level: Integrity, Delivers Results, Business Acumen, Champions Change, Engages, and DevelopsResponds to problems and identifies solutions; develops methods to address constraints and waits for approval before implementationCollaborates effectively with others; handles conflict constructively and communicates necessary informationBuilds trust by acting ethically and inclusively; ensures compliance with regulations, policies, and standards; raises questions or concerns when neededPreferred Skills & BackgroundVeterinary or Human Pharmaceutical Quality Assurance or Quality Control experience strongly preferredWhy You Should Join CatalentDefined career path with annual performance reviews and feedbackDiverse and inclusive cultureOpportunities for career growth within an organization dedicated to improving livesCompetitive paid time off plus 8 paid holidaysCommunity engagement and green initiativesMedical, dental, and vision benefits effective on day oneTuition reimbursementCatalent 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.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.SummaryLocation: Kansas City, MOType: Full time