Quality Engineer I

Quality Engineer I

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent Pharma Solutions in San Diego is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. We focus on bringing client drug compounds from discovery to the clinic with services that include analytical development, pre-formulation testing, formulation development, GMP (Good Manufacturing Practices) manufacturing and stability storage and testing as well as Clinical Supply Services.  At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. 

Catalent Pharma in San Diego, CA is hiring a Quality Engineer (QE) I. The Quality Engineer will understand the relevant site systems and processes and begin to expand their knowledge of deviations and investigations and review requirements. The individual in this position is primarily responsible for the review and approval of investigations and deviations based upon regulations, corporate policies, and site procedures. This individual works with cross-functional teams to identify root causes and trends, implement lasting corrective actions, and drive continuous improvement in the investigation process. This position gives opportunities to develop analytical/manufacturing expertise and expand knowledge of overall site-wide operations in a fast-paced, early phase-focused, dynamic setting to assess the quality of pharmaceutical products under cGMP and minimal supervision.

This is a full-time salaried position: Monday – Friday, 1st shift from 8am-4pm on-site with flexibility offered.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role:

• Interfaces with internal teams and coordinates cross-departmental discussions to perform Root Cause Analysis (RCA)
• Writing and review of deviation and investigation details, RCA, and review of recurrence.  May begin to write complaints
• Identifies applicable corrective and preventative actions to facilitate deviation, investigation, and complaint closures
• Evaluates issues to identify root cause and trends and to ensure they are addressed with the appropriate degree of risk documentation
• Manages timelines for deviations and investigations to ensure they are addressed in a timely manner
• Provides knowledge of applicable activities, processes, data analysis, cross-departmental contribution, and limitations
• Grow understanding of cGMP, Catalent SOPs (Standard Operating Procedures) and Catalent systems applicable to work performed, and application of ICH (International Council for Harmonization) and FDA guidance
• Other duties as assigned

The Candidate:

• Bachelor’s degree in Science/Engineering is required with a minimum of two years of experience in the pharmaceutical/GMP industry. We will also accept a high school diploma with a minimum of five years of industry experience in a relatable QA function in a pharmaceutical GMP environment 
• Must have experience using Microsoft Office products. Preferred experience using TrackWise and SharePoint 
• Must be highly detail-oriented and organized, able to work both independently and as a team player, with a positive and collaborative attitude
• Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift up to 20 pounds; ability to communicate orally with customers, vendors, and co-workers. Regular use of telephone and email. Hearing, vision, and speaking within normal ranges is essential for normal conversations, to receive ordinary information and to prepare or inspect documents. Good manual dexterity for the use of common office equipment such as computer terminals, ca