Quality Assurance Specialist I

Catalent • San Diego, CA

2d • $72,000 - $74,000 • Onsite

About The Position

The Quality Assurance Specialist I supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements.

Requirements

• High School Diploma or GED required.
• High School Diploma with 7+ years of relevant work experience in a GMP environment, or comparable pharmaceutical knowledge and experience.
• BS with 5+ years of experience in a GMP environment, or comparable pharmaceutical knowledge and experience.
• MS with 3+ years of experience in a GMP environment, or comparable pharmaceutical knowledge and experience.
• Minimum of 3 years of customer service experience.
• Proficient knowledge of MS Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUP’s, Excel Formulas, building presentations in PowerPoint, etc.).

Nice To Haves

• Bachelors or Master’s degree in a scientific discipline preferred.
• JD Edwards or comparable ERP systems preferred.

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.

Benefits

• Competitive salary with bonus potential.
• Generous 401K match
• Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment.
• 152 hours of PTO
• 10 paid holidays
• Tuition Reimbursement
• WellHub program to promote overall physical wellness.
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED