Quality Assurance Specialist II

Quality Assurance Specialist II – San Diego By Catalent, Inc., a leading global contract development and manufacturing organization (CDMO), this 100% on‑site position focuses on early‑stage development of small molecule and peptide drug candidates. Position Summary Supports clinical trial projects by ensuring compliance with regulatory requirements, good manufacturing practices (cGMP), and standard operating procedures. Responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. Responsibilities Perform pre- and post‑execution batch record review. Author and update documents related to material management quality control, batch records, compliance, and validation systems. Participate in investigations and deviation writing. Support client communications. Review and approve change controls and change actions. Adhere to GMP standards routinely 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 experience in a GMP environment, or comparable pharmaceutical knowledge and experience. Bachelor of Science with 7+ years of experience in a GMP environment, or comparable pharmaceutical knowledge and experience. Master of Science with 5+ years of experience in a GMP environment, or comparable pharmaceutical knowledge and experience. Experience with JD Edwards or comparable ERP systems preferred. Proficient knowledge of MS Office and query‑based systems (e.g., Pivot Tables, VLOOKUP, Excel formulas, PowerPoint). Physical Requirements Frequent standing, walking, and sitting required; occasional lifting, pushing, and pulling of up to 35 lbs.; occasional kneeling and reaching. Pay The anticipated salary range for this role in California is $85,000 to $89,000 annually. Benefits Employee activities such as movie day, birthday celebrations, bagel breakfast, and on‑site fitness center. Environmentally friendly green initiatives and community engagement. Defined career path with annual performance reviews and feedback. Employee Resource Groups focusing on diversity and inclusion. Competitive salary with bonus potential. Generous 401(k) match and paid time off accrual. Medical, dental, and vision benefits effective day one. 152 hours of paid time off plus 10 paid holidays. Tuition reimbursement. WellHub program for overall wellness. Perkspot discount program. Equal Opportunity Employer Catalent is an Equal Opportunity Employer, including disability and veterans. Reasonable accommodation requests should be submitted to the Disability Accommodations team. #J-18808-Ljbffr Catalent