Quality Assurance Specialist I

About the role

This Quality Assurance Specialist I position supports clinical trial projects at Catalent's San Diego facility, ensuring compliance with regulatory requirements, GMP, and SOPs. The role involves implementing and maintaining quality assurance processes, performing quality reviews, conducting inspections, leading investigations, and training and mentoring colleagues.

Responsibilities

• Serve as a Quality Systems SME, using JDE to manage 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.

Requirements

• High School Diploma or GED required.
• 7+ years of relevant work experience in a GMP environment, or comparable pharmaceutical knowledge and experience.
• Bachelor's or Master's degree in a scientific discipline preferred.
• JD Edwards or comparable ERP systems preferred.
• Proficient knowledge of MS Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUP’s, Excel Formulas, building presentations in PowerPoint, etc.).

Qualifications

• Frequent standing, walking, and sitting required.
• Occasional lifting, pushing, and pulling of up to 35 lbs.
• Occasional kneeling and reaching required.

Skills

• Quality Systems expertise.
• MS Office proficiency.
• ERP system experience (JDE).

Benefits

Includes comprehensive benefits package, including medical, dental, and vision coverage, 401(k) matching, and paid time off. Catalent also offers tuition reimbursement, a fitness center, and various employee resource groups focused on diversity and inclusion.

Pay

The anticipated salary range for this role in California is $72,000 to $74,000 annually. Final salary offered will depend on experience, skills, and other factors.

Schedule

Monday-Friday, core hours 8am-4:30pm. On-site (San Diego).