Quality Assurance Specialist I

Overview Quality Assurance Specialist I. Schedule: Monday-Friday, core hours 8:00am-4:30pm. 100% on-site (San Diego). Catalent, Inc. is a global CDMO with a San Diego facility focused on early-stage development of small molecule and peptide drug candidates, offering services from pre-formulation testing to cGMP manufacturing, clinical packaging, labeling, and worldwide distribution. The Quality Assurance Specialist I supports clinical trial projects, ensuring work complies with regulatory requirements, cGMP, and SOPs. This role involves implementing and maintaining QA processes throughout the product lifecycle, ensuring documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements. Responsibilities Serve as a Quality Systems subject matter expert (SME), utilizing JDE to support material management, batch records, product inspection, label release, and quality processes. Independently perform quality review and release activities, including materials, labels, batch records, certificates of analysis/compliance, audits, and quality holds/releases. Conduct inspections of incoming materials, bulk drug products, finished goods, packaging operations, and quality incidents to ensure GMP and regulatory compliance. Lead and support investigations, deviations, complaints, change controls, engineering studies, equipment qualifications, and corrective actions. Author, review, update, and approve quality documentation, procedures, reports, and regulatory records. Partner with cross-functional teams and clients to resolve quality issues, provide guidance, present quality metrics, and drive rapid-response activities. Train, mentor, and develop Quality Specialists while supporting onboarding, process improvements, and continuous quality enhancements. Demonstrate a One Catalent approach by collaborating across site and global quality functions to maintain compliance, operational excellence, and customer satisfaction. Perform other duties as assigned. Candidate Qualifications Education: High School Diploma or GED required. Higher degrees or years of GMP experience to specified levels in the original description (e.g., BS/MS with relevant experience) are acceptable in lieu of or in addition to the minimum requirements. Experience: 7+ years (High School Diploma path) or a BS with 5+ years or an MS with 3+ years of GMP/pharmaceutical experience; minimum 3 years of customer service experience. Preferred: Bachelors or Master’s degree in a scientific discipline; JD Edwards or comparable ERP systems; proficient MS Office and query-based skills (Pivot Tables, VLOOKUP, Excel formulas, PowerPoint). Physical Requirements Frequent standing, walking, and sitting. Position may require lifting, pushing, and pulling up to 35 lbs; occasional kneeling and reaching. Compensation and Benefits Pay: California range $72,000 to $74,000 annually. Final salary depends on experience and other factors. Benefits: Medical, dental, vision; 152 hours of PTO + 10 paid holidays; 401(k) with company match; tuition reimbursement; WellHub program; discount programs; and other employee benefits as described by Catalent. Equal Opportunity 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 email with the job number, title, and location to View email address on click.appcast.io. #J-18808-Ljbffr Catalent Pharma Solutions