Quality Assurance Specialist II

Position Summary Quality Assurance Specialist II – supports clinical trial projects through quality assurance processes throughout the product lifecycle. Work Schedule: Monday-Friday, core hours 8:00am-4:30pm, 100% on-site (San Diego). This position is part of Catalent’s San Diego facility, which focuses on early-stage development of small molecule and peptide drug candidates. Responsibilities Pre- and post-execution batch record review Authoring and updating documents related to Material Management Quality Control, Material Management Quality Assurance, Batch Records, Compliance, and Validation Systems Participate in investigations and deviation writing Support client communications Review and approve change controls and action plans Adhere to GMP standards with limited errors and guidance Other duties as assigned Qualifications High School Diploma or GED required; Bachelor’s or Master’s degree in a scientific discipline preferred High School Diploma with 10+ years of relevant GMP experience, or comparable pharmaceutical knowledge and experience BS with 7+ years in GMP environment, or comparable experience MS with 5+ years in GMP environment, or comparable experience JD Edwards or comparable ERP systems preferred Proficient knowledge of MS Office and query-based systems (Pivot Tables, VLOOKUP, Excel formulas, PowerPoint) Physical Requirements Frequent standing, walking, and sitting; occasional lifting up to 35 lbs, kneeling, and reaching. Compensation Annual salary range: $85,000 – $89,000 (California). Final salary determined by experience, education, and business needs. Equal Opportunity Statement All qualified applicants, including those who are disabled or veterans, will receive equal consideration for employment. Applicants requiring reasonable accommodations for the application or hiring process should contact View email address on click.appcast.io with the job number, title, and location. #J-18808-Ljbffr