Quality Assurance Specialist I

Position Summary Work Schedule: Monday‑Friday, core hours 8am‑4:30pm; 100% on‑site (San Diego). Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Our San Diego facility focuses on early‑stage development of small molecule and peptide drug candidates from bench to clinic, supporting oral and injectable dosage forms and offering services that include pre‑formulation testing, formulation and analytical development, cGMP manufacturing, clinical packaging, labeling, and worldwide distribution. The location is the home of Catalent’s Spray Drying technologies with downstream roller compaction capabilities. 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 compliance with GMP and regulatory requirements. 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 effective rapid‑response activities. Train, mentor, and develop Quality Specialists while supporting onboarding, process improvements, and continuous quality enhancement initiatives. Demonstrate a One Catalent approach by collaborating across site and global quality functions to maintain compliance, operational excellence, and customer satisfaction. Other duties as assigned. Qualifications High School Diploma or GED required. High School Diploma with 7+ years of relevant work experience in a GMP environment, or comparable pharmaceutical knowledge. Bachelor’s degree with 5+ years of experience in a GMP environment, or comparable pharmaceutical knowledge. Master’s degree with 3+ years of experience in a GMP environment, or comparable pharmaceutical knowledge. Minimum of 3 years of customer service experience. Bachelors or Master’s degree in a scientific discipline preferred. JD Edwards or comparable ERP systems experience preferred. Proficient knowledge of MS Office software and query‑based systems activities (e.g., Pivot Tables, VLOOKUP, Excel formulas, PowerPoint presentations). Physical Requirements: frequent standing, walking, and sitting; occasional lifting, pushing, pulling up to 35 lbs; occasional kneeling and reaching. Pay The anticipated salary range for this role in California is $72,000 to $74,000 annually. The final salary offered may vary based on experience, industry, skills, education, and business needs. Benefits Competitive salary with bonus potential. Generous 401K match and paid time off accrual. Medical, dental, and vision benefits effective day one. 152 hours of PTO plus 10 paid holidays. Tuition reimbursement. WellHub program to promote overall physical wellness. Perkspot discounts with over 900 merchants. Employee resource groups focused on diversity and inclusion. Environmentally friendly initiatives and community engagement events. Positive, fast‑paced environment focused on continuous process improvement. 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, please submit your request by emailing the accommodation team with the job number, title, and location to View email address on click.appcast.io. #J-18808-Ljbffr